Psychoeducation (brief) for people with serious mental illness (Review) Zhao S, Sampson S, Xia J, Jayaram MB

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 4 http://www.thecochranelibrary.com

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS

HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . . BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.1. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance. . . . . . . . . . . . . . . . . Analysis 1.2. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With medication - partial compliance (medium term). . . . . . . . . . Analysis 1.4. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 4 Compliance: 1d. With medication - very good/ good compliance (numberic compliance scale). . Analysis 1.5. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 5 Compliance: 2a. With follow-up - loss to follow-up for any reason. . . . . . . . . . . . Analysis 1.6. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 6 Relapse: 1. Relapse for any reason. . . . . . . . . . . . . . . . . . . . . . . Analysis 1.7. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 7 Relapse: 2. Relapse with readmission. . . . . . . . . . . . . . . . . . . . . . Analysis 1.8. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales. . . . . . . . . Analysis 1.11. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 11 Knowledge: 2. Average endpoint scores (SAUMD, high = poor) (short term). . . . . . . . Analysis 1.12. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 12 Global state: 2. Average endpoint scale score. . . . . . . . . . . . . . . . . . . Analysis 1.13. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 13 Service utilisation: rehospitalisation. . . . . . . . . . . . . . . . . . . . . . Analysis 1.14. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 14 Mental state: 1a. Global - average total endpoint scale scores (BPRS, high = poor). . . . . . Analysis 1.15. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 15 Mental state: 1b. Global - average change scale scores (GWB/SES, high = good) (medium term). Analysis 1.17. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 17 Mental state: 2a. Specific symptoms - short term. . . . . . . . . . . . . . . . . . Analysis 1.18. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 18 Mental state: 2b. specific symptoms - average total endpoint scale score (high = poor) (short term). Analysis 1.20. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 20 Social functioning: 1a. Average change scores on various scales (high = poor) (medium term). . . Analysis 1.21. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 21 Expressed emotion: Participants with high EE relatives (FQ). . . . . . . . . . . . . . Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Analysis 1.22. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 22 Expressed emotion for relatives: Average change scores on FQ scales (high = good). . . . . . Analysis 1.23. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good). . . . . . . . . . Analysis 1.24. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 24 Quality of life: 1b. Average endpoint scores (FAD, high = poor). . . . . . . . . . . . . Analysis 1.26. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 26 Satisfaction with mental health services: 1. Average change score (VSS, high = good) (short term). Analysis 1.27. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 27 Satisfaction with mental health services: 2. Average change (VSS Scale, high = good) (long term at 1 year). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.28. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 28 Patients’ satisfaction with mental health services: average endpoint scores (CSQ, high = good) (short term). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.29. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 29 Adverse event: Death. . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 2.1. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Compliance: With medication (numberic compliance scale, high = good). . . . . . . . . . . . . . . . . . . . . Analysis 2.2. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 2.3. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 3 Service utilisation: hospitalisation (long term). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 2.4. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 4 Mental state: Specific - average endpoint PANSS scores (high = poor). . . . . . . . . . . . . . . . . . . . . . . Analysis 2.5. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 5 Quality of life: Average endpoint MSQoL-54 score (high = good). . . . . . . . . . . . . . . . . . . . . . . . . Analysis 3.1. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication non-compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 3.2. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With follow up loss to follow-up for any reason. . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 3.3. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 3 Relapse: 1. Relapse for any reason. Analysis 4.1. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Relapse: Relapse for any reason (medium term). . . . . . . Analysis 4.2. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term)-without assumption. Analysis 5.1. Comparison 5 SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance. . . . . . . ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Review]

Psychoeducation (brief) for people with serious mental illness Sai Zhao1 , Stephanie Sampson2 , Jun Xia3 , Mahesh B Jayaram4 1

Tianjin University of Traditional Chinese Medicine, Tianjin, China, Systematic Review Solutions Ltd, Yan Tai, China. 2 The University of Nottingham, Nottingham, UK. 3 Cochrane Schizophrenia Group, The University of Nottingham, Nottingham, UK. 4 Department of Psychiatry, Melbourne Neuropsychiatry Centre, Melbourne, Australia Contact address: Sai Zhao, Tianjin University of Traditional Chinese Medicine, Tianjin, China, Systematic Review Solutions Ltd, 5-6 West Tashan Road, Yan Tai, 264000, China. [email protected]. Editorial group: Cochrane Schizophrenia Group. Publication status and date: New, published in Issue 4, 2015. Review content assessed as up-to-date: 4 February 2014. Citation: Zhao S, Sampson S, Xia J, Jayaram MB. Psychoeducation (brief ) for people with serious mental illness. Cochrane Database of Systematic Reviews 2015, Issue 4. Art. No.: CD010823. DOI: 10.1002/14651858.CD010823.pub2. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background Those with serious/severe mental illness, especially schizophrenia and schizophrenic-like disorders, often have little to no insight regarding the presence of their illness. Psychoeducation may be defined as the education of a person with a psychiatric disorder regarding the symptoms, treatments, and prognosis of that illness. Brief psychoeducation is a short period of psychoeducation; although what constitutes ’brief psychoeducation’ can vary. A previous systematic review has shown that the median length of psychoeducation is around 12 weeks. In this current systematic review, we defined ’brief psychoeducation’ as programmes of 10 sessions or less. Objectives To assess the efficacy of brief psychoeducational interventions as a means of helping severely mentally ill people when added to ’standard’ care, compared with the efficacy of standard care alone. The secondary objective is to investigate whether there is evidence that a particular kind (individual/ family/group) of brief psychoeducational intervention is superior to others. Search methods We searched the Cochrane Schizophrenia Group register September 2013 using the phrase: [*Psychoeducat* in interventions of STUDY]. Reference lists of included studies were also inspected for further relevant studies. We also contacted authors of included study for further information regarding further data or details of any unpublished trials. Selection criteria All relevant randomised controlled trials (RCTs) comparing brief psychoeducation with any other intervention for treatment of people with severe mental illness. If a trial was described as ’double blind’ but implied randomisation, we entered such trials in a sensitivity analysis. Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Data collection and analysis At least two review authors extracted data independently from included papers. We contacted authors of trials for additional and missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data. For continuous data, we calculated the mean difference (MD), again with 95% CIs. We used a fixed-effect model for data synthesis, and also assessed data using a random-effects model in a sensitivity analysis. We assessed risk of bias for each included study and created ’Summary of findings’ tables using GRADE (Grading of Recommendations Assessment, Development and Evaluation). Main results We included twenty studies with a total number of 2337 participants in this review. Nineteen studies compared brief psychoeducation with routine care or conventional delivery of information. One study compared brief psychoeducation with cognitive behavior therapy. Participants receiving brief psychoeducation were less likely to be non-compliant with medication than those receiving routine care in the short term (n = 448, 3 RCTs, RR 0.63 CI 0.41 to 0.96, moderate quality evidence) and medium term (n = 118, 1 RCT, RR 0.17 CI 0.05 to 0.54, low quality evidence). Compliance with follow-up was similar between the two groups in the short term (n = 30, 1 RCT, RR 1.00, CI 0.24 to 4.18), medium term (n = 322, 4 RCTs, RR 0.74 CI 0.50 to 1.09) and long term (n = 386, 2 RCTs, RR 1.19, CI 0.83 to 1.72). Relapse rates were significantly lower amongst participants receiving brief psychoeducation than those receiving routine care in the medium term (n = 406, RR 0.70 CI 0.52 to 0.93, moderate quality evidence), but not in the long term. Data from a few individual studies supported that brief psychoeducation: i) can improve the long-term global state (n = 59, 1 RCT, MD -6.70 CI -13.38 to -0.02, very low quality evidence); ii) promote improved mental state in short term (n = 60, 1 RCT, MD -2.70 CI -4.84 to -0.56,low quality evidence) and medium term; iii) can lower the incidence and severity of anxiety and depression. Social function such as rehabilitation status (n = 118, 1 RCT, MD -13.68 CI -14.85 to -12.51, low quality evidence) and social disability (n = 118, 1 RCT, MD -1.96 CI -2.09 to -1.83, low quality evidence) were also improved in the brief psychoeducation group. There was no difference found in quality of life as measured by GQOLI-74 in the short term (n = 62, 1 RCT, MD 0.63 CI -0.79 to 2.05, low quality evidence), nor the death rate in either groups (n = 154, 2 RCTs, RR 0.99, CI 0.15 to 6.65, low quality evidence). Authors’ conclusions Based on mainly low to very low quality evidence from a limited number of studies, brief psychoeducation of any form appears to reduce relapse in the medium term, and promote medication compliance in the short term. A brief psychoeducational approach could potentially be effective, but further large, high-quality studies are needed to either confirm or refute the use of this approach.

PLAIN LANGUAGE SUMMARY The effectiveness of brief psychoeducation (10 sessions or less) for people with serious mental illness Review question. To investigate the effectiveness of brief psychoeducation compared with standard care as a means of helping people with serious mental illness. To investigate whether any kind (individual/ family/group) of brief psychoeducation is better than others. Background. Schizophrenia is a serious, long-term mental illness where people experience hallucinations and/or delusions and are often unable to distinguish these experiences from reality. Hearing voices and seeing things can be disturbing, confusing and frightening and can lead to changes in behaviour. It is suggested that insight into the illness can help people to understand the need for treatment and subsequently improve the prognosis. However, the nature of schizophrenia is such that it alters peoples thought processes and they are often unable to have insight into their illness. The stigma of having a mental illness can also influence a person’s willingness to seek or take treatments. Effective education of people with schizophrenia can improve insight and understanding. Psychoeducation programmes have been developed, specifically aimed at people with mental health problems. It is not simply providing information to patients. Rather, it is a form of empowering training targeted at promoting awareness and providing tools to manage, cope and live with a mental illness. However, psychoeducation Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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can be time consuming; brief psychoeducation has been developed as a possible solution to this problem. In this review the authors defined brief psychoeducation to be a psychoeducation programme of 10 sessions or less. Study characteristics. The review authors searched for randomised trials in 2013 and found 20 relevant studies with 2337 participants. Half of the studies were carried out in China. These trials randomised people to receive either brief psychoeducation sessions (these ranged from one-day psychoeducation to eight sessions of psychoeducation over a period of one year) or routine care. Key results. Based on information from a limited number of studies, brief psychoeducation does seem to reduce relapse and encourage people to take their medication. Those receiving brief psychoeducation also have more favourable results for mental state and social functioning. Quality of the evidence. Although initial results are encouraging, most information and data for the main outcomes of interest, were rated as low or very low quality, and the number of trials providing useful data is small. Until further large, high-quality studies become available, the usefulness of brief psychoeducation remains debatable. Ben Gray, Senior Peer Researcher, McPin Foundation.http://mcpin.org/

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]

ANY FORM OF PSYCHOEDUCATION compared with ROUTINE CARE/INFORMATION for people with serious mental illness Patient or population: people with serious mental illness Settings: China (54%); Germany (14%); Denmark (8%); Pakistan (8%); Scotland (8%); Malaysia (8%). Intervention: ANY FORM OF PSYCHOEDUCATION Comparison: ROUTINE CARE/INFORMATION Outcomes

Illustrative comparative risks* (95% CI)

Assumed risk

Relative effect (95% CI)

No of Participants (studies)

Quality of the evidence (GRADE)

RR 0.63 (0.41 to 0.96)

448 (3 studies)

⊕⊕⊕ moderate2

RR 0.7 (0.52 to 0.93)

406 (4 studies)

⊕⊕⊕ moderate4

Corresponding risk ANY FORM OF BRIEF PSYCHOEDUCATION

Compliance: 1a. With Study population medication - non-com205 per 10001 pliance - short term Follow-up: 12 weeks

129 per 1000 (84 to 197)

Moderate 137 per 10001

Relapse: 1. Relapse for Study population any reason - medium 354 per 10003 term Follow-up: 12-52 weeks

86 per 1000 (56 to 132)

248 per 1000 (184 to 329)

Moderate 351 per 1000 3

246 per 1000 (183 to 326)

Comments

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Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Global state: 2. Average endpoint scale score medium term (GAF/GAS, high = good) Follow-up: 12-52 weeks

The mean global state: medium term in the control groups was -56.6 points

The mean global state: 2. average endpoint scale score - medium term (GAF/GAS, high = good) in the intervention groups was 0.5 lower (5.48 lower to 4.47 higher)

101 (2 studies)



very low5,6,7

Mental state: 1a. Global The mean mental state: - average total endpoint short term in the control scale scores (BPRS, group was 23.33 points high = poor) - short term Follow-up: up to 12 weeks

The mean mental state: 1a. global - average total endpoint scale scores (BPRS, high = poor) short term in the intervention groups was 2.7 lower (4.84 to 0.56 lower)

60 (1 study)

⊕⊕

very low5,8,9

Social functioning: 1a. Average change scores on various scales medium term (high = poor) - SDSS Follow-up: 12-52 weeks

The mean social functioning: medium term in the control groups was -0.29 points

The mean social functioning: medium term in the intervention groups was 1.96 lower (1.83 to 2.09 lower)

118 (1 study)

⊕⊕

low8,9

Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good) - short term Follow-up: up to 12 weeks

The mean quality of life: short term in the control groups was 16.72 points

The mean quality of life: short term in the intervention groups was 0.63 higher (0.79 lower to 2.05 higher)

62 (1 study)

⊕⊕

low8,9

154 (2 studies)

⊕⊕

low5,7

Adverse event: Death - Study population medium term Follow-up: 12-52 weeks

RR 0.99 (0.15 to 6.65)

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Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

13 per 100010

13 per 1000 (2 to 85)

Moderate 23 per 100010

23 per 1000 (3 to 153)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 Assumed

risk: median control group risk presented from studies, as little variation in baseline risk across studies (13.7%). Risk of bias: rated ’serious’ - two included studies rated as a ’high’ risk of bias across at least one of the ’Risk of bias’ domains, including selective reporting and incomplete outcome data. 3 Assumed risk: median control group risk presented from studies, as little variation in baseline risk across studies (35.1%). 4 Risk of bias: rated ’serious’ - three included studies rated as a ’unclear’ risk of bias across at least one of the ’Risk of bias’ domains, including selective reporting and incomplete outcome data. 5 Risk of bias: rated ’serious’ - one included study rated as a ’high’ risk of bias across at least one of the risk of bias domains, including incomplete outcome data. 6 Inconsistency: rated as ’serious’ - a considerable heterogeneity was detected (I2 = 58%). 7 Imprecision: rated ’serious’ - confidence intervals for best estimate of effect include both no effect and appreciable benefit/ harm. 8 Imprecision: rated as ’serious’, too small sample size. 9 We strongly suggested a publication bias because only one studies was included. 10 Assumed risk: median control group risk presented from studies, as little variation in baseline risk across studies (2.3%).

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BACKGROUND

Description of the condition The term ’serious’ or ’severe’ mental illness is widely used by mental health professionals, but there is no internationally agreed definition for the term, and limited consistency between definitions. The definition of severe mental illness which is most representative of definitions used in research is that of the National Institute of Mental Health (NIMH) (Schinnar 1990), which has three dimensions. 1. Clinical diagnosis: a diagnosis of non-organic psychosis or personality disorder. 2. Chronicity: a two-year, or longer history of mental illness or treatment. 3. Disability: functional impairment, limiting one or more major life activities (National Institute of Mental Health 1987). The UK Quality and Outcomes Framework, which encourages General Practices to maintain registers of patients with severe mental illness, uses the following inclusion criteria, based on diagnosis alone: schizophrenia, bipolar disorder and other psychoses (QOF 2009). This is representative of definitions used by the UK Department of Health, and used in practice. Ruggeri 2000 suggested that the total worldwide population-based annual prevalence of serious mental illness is approximately two per thousand. Current mental health policy objectives include ensuring optimal quality of life for those with severe mental illness, and providing evidencebased approaches to give people the greatest choice and control over their own lives (DoH 2011). Those with severe mental illness, especially schizophrenia and schizophrenic-like disorders, often have little to no insight regarding the presence of their illness (McCormack 2013). This means that people with severe mental illness will not understand that they are ill in the same way that third party observers do. The lack of understanding of their illness, ultimately leads to poor treatment compliance and can result in relapse and repeated hospitalisation (Gerhardstein 2013). Some people may feel stigmatised by their illness and may deny its existence, whereas others have a true lack of understanding (Harvey 2013); both, ultimately increase noncompliance. Non-compliance is even more of a problem when people are living in the community and is also often related to the adverse effects of medication, as well as a lack of adequate knowledge about medication (Antai-Otong 1989).

psychiatric condition, and changing behaviours and attitudes related to the condition (Colom 2011). Patient education can take a variety of forms and length. Some are as brief as one session (Razali 1997), others are as long as 18 months (Herz 2000). A previous systematic review has shown that the median length of psychoeducation is around 12 weeks (Xia 2011). Therefore, for psychoeducation to be considered ’brief ’ we have used a cut-off of 10 sessions or less. The terms ’patient education’, ’patient teaching’, and ’patient instruction’ have also been used for this process. All imply that there is a focus on knowledge. The purpose of patient education, ultimately, is to enable the patient to engage in behaviour change and build skills for illness management (Chien 2013c). The goal may be to try to prevent hospitalisation or to manage the illness or condition to help the patient attain her/his maximum degree of health and well-being.

How the intervention might work Education is a gradual process by which a person gains knowledge and understanding through learning. Learning, however, involves more than knowledge and, according to Rankin 1996, it can involve cognitive, affective and psychomotor processes. Learning implies changes in behaviour, skill or attitude (Falvo 1994). Patient education can take a variety of forms depending upon the abilities and interest of the patient and family. For example, the education may take place in small groups or on a one-to-one basis; it may involve the use of videotapes or pamphlets or a combination of these.

Why it is important to do this review Proposed benefits of psychoeducation as a psychological intervention are that it is clinically focused, straightforward to deliver, and does not require long and complex training (Colom 2011). However, a key drawback is that psychoeducation traditionally places demands upon therapist time, with programmes often comprising many modules. A recent narrative literature review has suggested that shorter psychoeducation programmes or ’brief psychoeducation’ may have long-term positive outcomes in schizophrenia (Rummel-Kluge 2008). It is therefore important to look at brief psychoeducation programmes.

Description of the intervention Psychoeducation may be defined as the education of a person with a psychiatric disorder regarding the symptoms, treatments, and prognosis of that illness. It is not simply ’providing information’, but rather empowering training for patients targeted at promoting awareness, providing tools to manage, cope and live with a chronic

OBJECTIVES To assess the efficacy of brief psychoeducational interventions as a means of helping severely mentally ill people when added to ’standard’ care, compared with the efficacy of standard care alone.

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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The secondary objective is to investigate whether there is evidence that a particular kind (individual/ family/group) of brief psychoeducational intervention is superior to others.

METHODS

Criteria for considering studies for this review

a multidimensional viewpoint, including familial, social, biological and pharmacological perspectives. Patients were provided with support, information and management strategies. Interventions including elements of behavioural training, such as social skills or life-skills training, as well as education, performed by patient peers, were excluded from this review. Staff education studies were also excluded. 2. Standard care was defined as the normal level of psychiatric care provided in the area where the trial was carried out.

Types of outcome measures Types of studies All relevant randomised controlled trials. If a trial was described as ’double blind’ but implied randomisation, we included such trials in a sensitivity analysis (see Sensitivity analysis). If their inclusion did not result in a substantive difference, they remained in the analyses. If their inclusion did result in important clinically significant but not necessarily statistically significant differences, we did not add the data from these lower quality studies to the results of the better trials, but presented such data within a subcategory. We excluded quasi-randomised studies, such as those allocating by alternate days of the week. Where people were given additional treatments within brief psychoeducation, we only included data if the adjunct treatment was evenly distributed between groups and it was only the brief psychoeducation that was randomised.

We divided all outcomes into short term (up to 12 weeks), medium term (13-52 weeks) or long term (over 52 weeks), and were interpreted as defined by each of the studies.

Primary outcomes

1. Compliance 1.1 Compliance with medication 1.2 Compliance with follow-up

2. Relapse

Types of participants Adults suffering from severe/serious mental illness as defined by National Institute of Mental Health 1987. In the absence of a formal diagnosis, we included people with illness such as schizophrenia, schizophrenia-like disorders, bipolar disorder, depression with psychotic features and/or personality disorder. Studies involving people with dual diagnosis of severe mental illness plus substance abuse were also included. However, trials involving particIpants with substance abuse alone were not included. Studies involving people with dementia or mental retardation were also excluded, as these illnesses are not considered as severe mental disorders. We included studies involving people with a range of severe mental illness diagnoses but only where the majority of people had a diagnosis of schizophrenia. A majority of the study participants were required to be within the age range 18 to 65 years.

Secondary outcomes

3. Knowledge 3.1 Improvement of understanding of his/her illness and need for treatment - recipient/family member 3.2 Level of knowledge about expected and undesired effects of medication - recipient/family member

4. Behaviour 4.1 Level of psychiatric symptoms 4.2 Symptom control skills 4.3 Problem-solving skills 4.4 Social skills

Types of interventions 1. All didactic interventions of psychoeducation or patient teaching, involving individuals or groups, considered to be ’brief ’ were included. For the purpose of this review, programmes of 10 sessions or less were considered as ’brief ’. We defined psychoeducational interventions as any group or individual programme involving interaction between information provider and patient. These programmes addressed the illness from

5. Global state 5.1 Overall improvement 5.2 Use of additional medication 5.3 Average endpoint in global state score 5.4 Average change in global state scores 5.5 Average dose of drug

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6. Global functioning

13. Adverse effects/event

6.1 Clinically important change in general functioning 6.2 Any change in general functioning 6.3 Average endpoint in general functioning score 6.4 Average change in general functioning scores

13.1 Clinically important general adverse effects 13.2 Any general adverse effects 13.3 Any serious, specific adverse effects 13.4 Average endpoint general adverse effect score 13.5 Average change in general adverse effect scores 13.6 Clinically important change in specific adverse effects 13.7 Any change in specific adverse effects 13.8 Average endpoint specific adverse effects 13.9 Average change in specific adverse effects

7. Service utilisation 7.1 Use of outpatient treatment 7.2 Length of hospitalisation

14. Health economic outcomes 8. Mental state

14.1 Treatment costs

8.1 Clinically important change in general mental state 8.2 Any change in general mental state 8.3 Average endpoint in general mental state score 8.4 Average change in general mental state scores

15. ’Summary of findings’ table

9. Social functioning 9.1 Clinically important change in social functioning 9.2 Any change in social functioning 9.3 Average endpoint in social functioning score 9.4 Average change in social functioning scores

10. Expressed emotion 10.1 Clinically important change in expressed emotion 10.2 Any change in expressed emotion 10.3 Average endpoint general expressed emotion score 10.4 Average change in general expressed emotion scores

11. Quality of life 11.1 Clinically important change in quality of life 11.2 Any change in quality of life 11.3 Average endpoint quality of life score 11.4 Average change in quality of life scores 11.5 Clinically important change in specific aspects of quality of life 11.6 Any change in specific aspects of quality of life 11.7 Average endpoint specific aspects of quality of life 11.8 Average change in specific aspects of quality of life

We used the GRADE approach to interpret findings (Schünemann 2008) and used GRADE profiler (GRADEPRO) to import data from RevMan 5.1 (Review Manager) to create ’Summary of findings’ tables. These tables provided outcome-specific information concerning the overall quality of evidence from each included study in the comparison, the magnitude of effect of the interventions examined, and the sum of available data on all outcomes we rated as important to patient-care and decision making. We selected the following main outcomes for inclusion in the ’Summary of findings’ table: 1. Compliance - compliance with medication 2. Relapse - as defined in each study 3. Global state - overall improvement 4. Mental state - clinically important change in general mental state 5. Social function - clinically important change in social functioning 6. Quality of life - clinically important change in quality of life 7. Adverse effects - clinically important general adverse effects

Search methods for identification of studies Electronic searches We searched the Cochrane Schizophrenia Group register September 2013 using the phrase: [*Psychoeducat* in interventions of STUDY]. This register is compiled by systematic searches of major databases, hand searches and conference proceedings (see Group Module).

12. Satisfaction with care 12.1 Clinically important change in satisfaction 12.2 Any change in satisfaction 12.3 Average endpoint in satisfaction score 12.4 Average change in satisfaction scores

Searching other resources

1. Reference searching

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We inspected references of all included studies for further relevant studies.

2. Personal contact

We contacted the first author of each included study for information regarding unpublished trials. If authors responded we noted their responses in Characteristics of included studies.

Data collection and analysis

2.2 Scale-derived data We included continuous data from rating scales only if: a) the psychometric properties of the measuring instrument have been described in a peer-reviewed journal (Marshall 2000); and b) the measuring instrument has not been written or modified by one of the trialists for that particular trial. Ideally, the measuring instrument should either be i. a self-report or ii. completed by an independent rater or relative (not the therapist). We realise that this is not often reported clearly, in Description of studies we noted if this was the case or not.

Selection of studies

2.3 Endpoint versus change data

Review author SZ inspected citations from the searches and identified relevant abstracts. A random 20% sample was independently re-inspected by JX to ensure reliability. Where disputes arose, the full report was acquired for more detailed scrutiny. Full reports of the abstracts meeting the review criteria were obtained and inspected by SZ. A random 20% of reports were re-inspected by JX in order to ensure reliable selection. Where it was not possible to resolve disagreement by discussion, we contacted the authors of the study for clarification.

There are advantages of both endpoint and change data. Change data can remove a component of between-person variability from the analysis. On the other hand, calculation of change needs two assessments (baseline and endpoint), which can be difficult in unstable and difficult to measure conditions such as schizophrenia. We decided primarily to use endpoint data, and only use change data where the former were not available. Had we extracted endpoint and change data from the same scales, they would have been combined in the analysis through use of standardised mean differences (SMD) rather than mean differences (MD) throughout (Higgins 2011).

Data extraction and management 2.4 Skewed data 1. Extraction

Review authors SS and AA (working as a team) extracted data from all included studies parallel to SZ . In addition, to ensure reliability, JX independently extracted data from a random sample of these studies, comprising 10% of the total. Again, any disagreement was discussed, decisions documented and, if necessary, authors of studies were contacted for clarification. We planned to consult MBJ for clarification of any remaining problems , but we did not request his assistance during this process Where data were presented only in graphs and figures, we attempted to extract the data whenever possible and include such data but only where the review authors independently found the same result. We attempted to contact authors through an open-ended request in order to obtain missing information or for clarification whenever necessary. Where studies were multi-centre, where possible, we extracted data relevant to each component centre separately.

2. Management

2.1 Forms We extracted data onto standard, simple forms.

Continuous data on clinical and social outcomes are often not normally distributed. To avoid the pitfall of applying parametric tests to non-parametric data, we aimed to apply the following standards to all data before inclusion: a) standard deviations (SDs) and means were reported in the paper or obtainable from the authors; b) when a scale starts from the finite number zero, the SD, when multiplied by two, is less than the mean (as otherwise the mean is unlikely to be an appropriate measure of the centre of the distribution, (Altman 1996); c) if a scale started from a positive value (such as the Positive and Negative Syndrome Scale (PANSS), (Kay 1986)), which can have values from 30 to 210), the calculation described above was modified to take the scale starting point into account. In these cases skew is present if 2 SD > (S-S min), where S is the mean score and ’S min’ is the minimum score. Endpoint scores on scales often have a finite start and end point and these rules can be applied. Skewed data pose less of a problem when looking at means if the sample size is large (> 200) and we entered these into the syntheses. We presented skewed endpoint data from studies of less than 200 participants as ’other data’ within the data and analyses section rather than enter such data into a statistical analyses.

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Measures of treatment effect When continuous data are presented on a scale that includes a possibility of negative values (such as change data), it is difficult to tell whether data are skewed or not. We presented and entered change data into analyses. 2.5 Common measure To facilitate comparison between trials, we intended to convert variables that can be reported in different metrics, such as days in hospital (mean days per year, per week or per month) to a common metric (e.g. mean days per month) - however, no such data were identified.

1. Binary data

For binary outcomes, we calculated a standard estimation of the risk ratio (RR) and its 95% confidence interval (CI). It has been shown that RR is more intuitive (Boissel 1999) than odds ratios and that odds ratios tend to be interpreted as RR by clinicians (Deeks 2000). The Number Needed to Treat/Harm (NNT/H) statistic with its CIs is intuitively attractive to clinicians but is problematic both in its accurate calculation in meta-analyses and interpretation (Hutton 2009). For binary data presented in the Summary of findings for the main comparison, where possible, we calculated illustrative comparative risks.

2.6 Conversion of continuous to binary Where possible, in future updates of this review, efforts will be made to convert outcome measures to dichotomous data. This can be done by identifying cut-off points on rating scales and dividing participants accordingly into ’clinically improved’ or ’not clinically improved’. It is generally assumed that if there is a 50% reduction in a scale-derived score such as the Brief Psychiatric Rating Scale (BPRS, Overall 1962) or the PANSS (Kay 1986), this could be considered as a clinically significant response (Leucht 2005; Leucht 2005a). If data based on these thresholds are not available, we will use the primary cut-off presented by the original authors.

2. Continuous data

For continuous outcomes, we estimated mean difference (MD) between groups. We preferred not to calculate effect size measures (standardised mean difference SMD). Had scales of very considerable similarity been used, we would have presumed there was a small difference in measurement, and we would have calculated effect size and transformed the effect back to the units of one or more of the specific instruments. Unit of analysis issues

2.7 Direction of graphs Where possible, we entered data in such a way that the area to the left of the line of no effect indicates a favourable outcome for brief psychoeducation. Where keeping to this makes it impossible to avoid outcome titles with clumsy double-negatives (e.g. ’Not improved’), we reported data where the left of the line indicates an unfavourable outcome. This is noted in the relevant graphs. Assessment of risk of bias in included studies Review authors SZ and MJ worked independently to assess risk of bias by using criteria described in the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011) to assess trial quality. This set of criteria is based on evidence of associations between overestimate of effect and high risk of bias of the article such as sequence generation, allocation concealment, blinding, incomplete outcome data and selective reporting. If the raters disagreed, the final rating was made by consensus, with the involvement of another member of the review group. Where inadequate details of randomisation and other characteristics of trials were provided, we contacted the authors of the studies in order to obtain further information. Had non-concurrence in quality assessment been found, this would have been reported, and all disputes would have been resolved by discussion. The level of risk of bias was noted in both the text of the review and in the Summary of findings for the main comparison.

1. Cluster trials

Studies increasingly employ ’cluster randomisation’ (such as randomisation by clinician or practice) but analysis and pooling of clustered data poses problems. Firstly, authors often fail to account for intra-class correlation in clustered studies, leading to a ’unit of analysis’ error (Divine 1992) whereby P values are spuriously low, CIs unduly narrow and statistical significance overestimated. This causes type I errors (Bland 1997; Gulliford 1999). No cluster trials were identified in this review’s trial search. In future versions, if cluster studies are included, where clustering is not accounted for in primary studies, we will present data in a table, with a (*) symbol to indicate the presence of a probable unit of analysis error and seek to contact first authors of studies to obtain intra-class correlation coefficients (ICCs) for their clustered data and to adjust for this by using accepted methods (Gulliford 1999). Where clustering has been incorporated into the analysis of primary studies, we will present these data as if from a non-cluster randomised study, but adjust for the clustering effect. We have sought statistical advice and have been advised that the binary data as presented in a report should be divided by a ’design effect’. This is calculated using the mean number of participants per cluster (m) and the ICC [Design effect = 1+(m-1)*ICC] (Donner 2002). If the ICC is not reported we will assume it to be 0.1 (Ukoumunne 1999).

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If cluster studies have been appropriately analysed taking into account ICCs and relevant data documented in the report, synthesis with other studies will be possible using the generic inverse variance technique. 2. Cross-over trials

Due to the nature of the intervention, cross-over trials were not anticipated, nor identified in our search. However, in future versions of this review, it will be considered that a major concern of cross-over trials is the carry-over effect. It occurs if an effect (e.g. pharmacological, physiological or psychological) of the treatment in the first phase is carried over to the second phase. As a consequence, on entry to the second phase the participants can differ systematically from their initial state despite a wash-out phase. For the same reason cross-over trials are not appropriate if the condition of interest is unstable (Elbourne 2002). As both effects are very likely in severe mental illness, we will only use data of the first phase of cross-over studies.

and adverse effects. For these outcomes, the rate of those who stay in the study - in that particular arm of the trial - were used for those who did not. We undertook a sensitivity analysis to test how prone the primary outcomes were to change when data only from people who completed the study to that point were compared to the ITT analysis using the above assumptions.

3. Continuous

3.1 Attrition In the case where attrition for a continuous outcome was between 0% and 50%, and data only from people who complete the study to that point are reported, we reproduced these.

3.2 Standard deviations 3. Studies with multiple treatment groups

Where a study involved more than two treatment arms, if relevant, the additional treatment arms were presented in the comparisons. If data were binary, these were simply added and combined within the two-by-two table. If data were continuous, we combined data following the formula in section 7.7.3.8 (Combining groups) of the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011). Where the additional treatment arms are not relevant, we did not use these data. Dealing with missing data

1. Overall loss of credibility

At some degree of loss of follow-up, data must lose credibility (Xia 2009). We chose that, for any particular outcome, should more than 50% of data have been unaccounted for, we would not reproduce these data or use them within analyses. If, however, more than 50% of those in one arm of a study were lost, but the total loss was less than 50%, we addressed this within the ’Summary of findings’ table by down-rating quality. Finally, we also downgraded quality within the ’Summary of findings’ table where loss was 25% to 50% in total. 2. Binary

In the case where attrition for a binary outcome was between 0% and 50% and where these data were not clearly described, we presented data on a ’once-randomised-always-analyse’ basis (an intention-to-treat (ITT) analysis). Those leaving the study early were all assumed to have the same rates of negative outcome as those who completed, with the exception of the outcome of death

If standard deviations (SDs) were not reported, we first tried to obtain the missing values from the authors. If not available, where there were missing measures of variance for continuous data, but an exact standard error (SE) and CIs available for group means, and either ’a P’ value or ’t’ value available for differences in mean, we calculated them according to the rules described in the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011). When only the SE was reported, SDs were calculated by the formula SD = SE * square root (n). Chapters 7.7.3 and 16.1.3 of the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011) present detailed formulae for estimating SDs from P values, t or F values, CIs, ranges or other statistics. If these formulae did not apply, we calculated the SDs according to a validated imputation method, which was based on the SDs of the other included studies (Furukawa 2006). Although some of these imputation strategies can introduce error, the alternative would have been to exclude a given study’s outcome and thus to lose information. We nevertheless examined the validity of the imputations in a sensitivity analysis excluding imputed values.

3.3 Last observation carried forward We anticipated that in some studies the method of last observation carried forward (LOCF) could be employed within the study report. As with all methods of imputation to deal with missing data, LOCF introduces uncertainty about the reliability of the results (Leucht 2007). Therefore, had LOCF data been used in the trial, if less than 50% of the data had been assumed, we planned to present and use these data and indicate that they were the product of LOCF assumptions. However, we did not come across data from trials employing LOCF.

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Assessment of heterogeneity

in the methods section of the trial report were compared with actually reported results.

1. Clinical heterogeneity

We considered all included studies initially, without seeing comparison data, to judge clinical heterogeneity. We simply inspected all studies for clearly outlying people or situations which we had not predicted would arise. When such situations or participant groups arose, these were fully discussed.

2. Funnel plot

These are again described in Section 10 of the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011). We are aware that funnel plots may be useful in investigating reporting biases but are of limited power to detect small-study effects. We did not use funnel plots as no outcomes had more than 10 studies reporting data.

2. Methodological heterogeneity

We considered all included studies initially, without seeing comparison data, to judge methodological heterogeneity. We simply inspected all studies for clearly outlying methods which we had not predicted would arise. When such methodological outliers arose, these were fully discussed. 3. Statistical heterogeneity

3.1 Visual inspection We visually inspected graphs to investigate the possibility of statistical heterogeneity. 3.2 Employing the I2 statistic Heterogeneity between studies was investigated by considering the I2 method alongside the Chi2 ’P’ value. The I2 provides an estimate of the percentage of inconsistency thought to be due to chance (Higgins 2003). The importance of the observed value of I 2 depends on i. magnitude and direction of effects and ii. strength of evidence for heterogeneity (e.g. ’P’ value from Chi2 test, or a confidence interval for I2 ). An I2 estimate greater than or equal to around 50% accompanied by a statistically significant Chi2 statistic, was interpreted as evidence of substantial levels of heterogeneity (Section 9.5.2 - Higgins 2011). When substantial levels of heterogeneity were found in the primary outcome, we explored reasons for heterogeneity (Subgroup analysis and investigation of heterogeneity). Assessment of reporting biases

Data synthesis We understand that there is no closed argument for preference for use of fixed-effect or random-effects models. The random-effects method incorporates an assumption that the different studies are estimating different, yet related, intervention effects. This often seems to be true to us and the random-effects model takes into account differences between studies even if there is no statistically significant heterogeneity. There is, however, a disadvantage to the random-effects model. It puts added weight onto small studies, which often are the most biased ones. Depending on the direction of effect, these studies can either inflate or deflate the effect size. We chose the fixed-effect model for all analyses. The reader is, however, able to choose to inspect the data using the randomeffects model. Subgroup analysis and investigation of heterogeneity

1. Subgroup analyses

1.1 Primary outcomes We planned to compare brief group psychoeducation and brief individual psychoeducation, for primary outcomes only. 1.2 Clinical state, stage or problem We proposed to undertake this review and provide an overview of the effects of brief psychoeducation for people with schizophrenia in general. In addition, however, we reported data on subgroups of people in the same clinical state, stage and with similar problems.

1. Protocol versus full study

Reporting biases arise when the dissemination of research findings is influenced by the nature and direction of results (Egger 1997). These are described in section 10.1 of the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011). We tried to locate the protocols of included randomised trials. If the protocol was available, outcomes in the protocol and in the published report were compared. If the protocol was not available, outcomes listed

2. Investigation of heterogeneity

If inconsistency was high, this was reported. First, we investigated whether data had been entered correctly. Second, if data were correct, we visually inspected the graph and outlying studies were successively removed to see if homogeneity was restored. For this review, we decided that should this occur with data contributing to the summary finding of no more than around 10% of the total

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weighting, data would be presented. If not, data were not pooled and issues were discussed. We know of no supporting research for this 10% cut-off, but are investigating use of prediction intervals as an alternative to this unsatisfactory state.

or the precision of the effect estimates, then data from these trials were included in the analysis.

When unanticipated clinical or methodological heterogeneity were obvious, we simply stated hypotheses regarding these for future reviews or versions of this review.

We had planned to undertake a sensitivity analysis to assess the effects of including data from trials where we used imputed values for ICC in calculating the design effect in cluster-randomised trials. If substantial differences had been noted in the direction or precision of effect estimates in any of the sensitivity analyses listed above, we would not have pooled data from the excluded trials with the other trials contributing to the outcome, but presented them separately. However, no cluster-randomised trials were identified.

Sensitivity analysis

1. Implication of randomisation

We aimed to include trials in a sensitivity analysis if they were described in some way as to imply randomisation. For the primary outcomes, we included these studies and if there was no substantive difference when the implied randomised studies were added to those with better description of randomisation, then all data were employed from these studies.

4. Imputed values

5. Fixed and random effects

All data were synthesised using a fixed-effect model, however, we also synthesised data for the primary outcome using a randomeffects model to evaluate whether this altered the significance of the results.

2. Assumptions for lost binary data

Where assumptions were made regarding people lost to followup (see Dealing with missing data), we compared the findings of the primary outcomes when we used our assumption/s and when we used data only from people who completed the study to that point. If there was a substantial difference, we reported results and discussed them, but continued to employ our assumption. Where assumptions were made regarding missing SDs data (see Dealing with missing data), we compared the findings of the primary outcomes when we used our assumption/s and when we used data only from people who completed the study to that point. A sensitivity analysis was undertaken to test how prone results were to change when completer-only data only were compared to the imputed data using the above assumption. If there was a substantial difference, we reported results and discussed them, but continued to employ our assumption.

RESULTS

Description of studies Please also see Characteristics of included studies and Characteristics of excluded studies. Throughout this review, study ID’s have received a prefix before the principal author’s name and year of study (Xia 2011); the prefixes used include ’group’, ’individual’, ’both or ’unclear’, and each correspond to whether the brief psychoeducation intervention was received either as a group, individually, a mixture of both group and individual, or whether lack of information renders how the intervention was received as ’unclear’ (e.g. see Both - Liu 2004; Group - Aguglia 2007; Individual - Cunningham 2001; Unclear - Li 2005). Results of the search

3. Risk of bias

We analysed the effects of excluding trials that were judged to be at high risk of bias across one or more of the domains of randomisation (implied as randomised with no further details available), allocation concealment, blinding and outcome reporting for the meta-analysis of the primary outcome. If the exclusion of trials at high risk of bias did not substantially alter the direction of effect

The search of the Cochrane Schizophrenia Group Trials Register, carried out in 2013, identified 268 references (see Figure 1), of which 20 studies were included (Characteristics of included studies), 19 were excluded (Characteristics of excluded studies), and 18 are awaiting classification (Characteristics of studies awaiting classification). Please refer to Figure 1 for the study screening process.

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Figure 1. Study flow diagram.

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Included studies

1. Setting

Ten of the 20 included studies were conducted in China, three studies were conducted in Germany, two in the UK, with the one each of the remaining studies conducted in either Italy, Malaysia, Pakistan, Denmark or Jamaica. Of the studies that described participant status, three studies included outpatients, and two conducted with hospital inpatients (one of which was an acute inpatient setting, Group - Bechdolf 2004). Three of the included studies were multi-centre (Group - Aguglia 2007; Group - Bauml 2007; Individual - Cunningham 2001).

5. Interventions

Types of brief family intervention differed between studies and ranged from one-day delivery (Group - Razali 1995) to sessions delivered over a period 12 months (Group - Aguglia 2007). We compared our defined brief family intervention (10 sessions or less) to standard/ routine care or information (as defined in each study), which included interventions such as cognitive behavioural therapy (CBT, as in Group - Bechdolf 2004), medication treatment alone (as specified in Group - Aguglia 2007; Group - Coyle 1988) or other routine forms of health education (Both - Zhang 2004) or rehabilitation (Both - Liu 2004). The remaining majority of the included studies used either the terms ’standard care’, ’routine care’ or simply ’no form of brief psychoeducation’ (however defined).

6. Outcome scales 2. Length of studies

Length of studies ranged from one day/one session (Group - Razali 1995) to eight sessions delivered over a period of 12 months ( Group - Aguglia 2007). The mean length of study was calculated at 13 weeks. Follow-up periods ranged from six months (Group Bechdolf 2004) to five years (Group - Hornung 1995).

3. Participants

In total, there were 2337 participants included in this review; only 50% of studies reported individual male and female numbers in study populations, with 612 known males and 473 known females included in, at least, 10 of the included studies. All participants had a diagnosis of schizophrenia or schizoaffective disorder; the most frequently used diagnostic criteria were Diagnostic and Statistical Manual of Mental Disorders (DSM-III or DSM-IV) (in nine of the included studies), Chinese Classification of Mental Disorders (CCMD-2 or CCMD-3) (in six of the included studies), International Classification of Diseases (ICD-9/10) (in one of the included studies) and F20.2/ F20.9 (in one of the included studies conducted in Denmark). The remaining three studies did not specify diagnostic criteria, but stated that participants had ’schizophrenia’. One of the included studies included acute patients (Group - Bechdolf 2004)

4. Trial size

Trial sizes ranged from n = 30 (Both - Tom 1989) to n = 286 participants (Unclear - Li 2005), with the mean sample size calculated at n = 117.

A variety of scales were used to assess clinical response and adverse events. We were, however, unable to use some of the scale-derived data due to poor reporting. Details of scales that provided usable data are shown below.

6.1 Compliance 6.1.1 Schedule for Assessment of Insight - SAI (David 1990) The SAI rates three dimensions of insight: treatment adherence, recognition of illness and symptom re-labelling. These three subscales provide a summed total of insight score. High score indicates better insight. One study reported skewed data from this scale. 6.1.2 Compliance scale ( Kemp 1998) The compliance scale is a four-point rating scale used by Kemp 1998, starting from 1 up to 4. A higher score represents better compliance: 1, complete or partial refusal (refused depot or accepts only minimum dose); 2, takes medication irregularly (interruption of medication < four weeks), reluctant, requires persuasion, disagrees with psychiatrist in charge about dose; 3, takes medication regularly (interruption of medication < one week), agrees with psychiatrist-in-charge about dose; 4, active participation, readily accepts and shows some responsibility for regimen.

6.2 Mental state 6.2.1 Brief Psychiatric Rating Scale - BPRS (Overall 1962) The BPRS is an 18-item scale measuring positive symptoms, general psychopathology and affective symptoms. The original scale has 16 items, but a revised 18-item scale is commonly used. Scores can range from 0 to 126. Each item is rated on a seven-point scale varying from ’not present’ to ’extremely severe’, with high scores indicating more severe symptoms. Four studies reported data from this scale.

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6.2.2 General Well-being Schedule - GWB (Taylor 2003) This is an 18-item, reliable measurement scale for psychological well-being. High scores indicate better outcome. One study reported data from this scale. 6.2.3 Positive and Negative Syndrome Scale - PANSS (Kay 1986) This is a 30-item scale, each of which can be defined on a sevenpoint scoring system from absent to extreme. It has three sub-scales for measuring the severity of general psychopathology, positive symptoms (PANSS-P), and negative symptoms (PANSS-N). A low score indicates lesser severity. One study reported data from this scale. 6.2.4 Rosenberg Self-esteem Scale - SES (Rosenberg 1965) The scale is a 10-item Likert scale with items answered on a fourpoint scale - from strongly agree to strongly disagree. High scores indicate better outcome. One study reported data from this scale. 6.2.5 Montgomery-Åsberg Depression Rating Scale - MADRS (Montgomery 1979) This is a 10-item, psychiatrist-administered scale to rate severity of depressive episodes in people with mood disorders. Overall scores range from 0 to 54 points, with a higher score indicating a worse outcome. One study reported skewed data using this scale. 6.2.6 Zung Self-Rating Anxiety Scale - SAS (Ramirez 2008) This scale is self-administered and has 20 questions. Each question is scored on a scale of one to four. High score indicates poor outcome. One study reported data from this scale. 6.2.7 Zung Self-Rating Depression Scale - SDS (Gregory 1994) High scores indicate a poor outcome. One study reported data from this scale. 6.3 Social functioning 6.3.1 Morningside Rehabilitation Status Scale - MRSS ( McCreadie 1987) High scores indicates a worse outcome. One study reported data from this scale. 6.3.2 Social Disability Screening Schedule - SDSS (Tu 1997) High scores indicate a poor outcome. One study reported data from this scale. 6.4 Quality of life 6.4.1 Family Assessment Device - FAD (Epstein 1983) High scores indicate unhealthy family functioning. One study reported data from this scale. 6.4.2 Family Burden Interview Schedule - FBIS (Pai 1981) High scores indicate a worse outcome. One study reported data from this scale. 6.4.3 General Quality of Life Inventory -74 - GQOLI-74 (Wang 1999) A 74-item quality of life assessment scale. It contains four subscales that assess physical functioning, psychological functioning, social functioning, and standard of living. High scores indicate better quality of life. One study reported data from this scale.

6.5 Knowledge 6.5.1 Insight Treatment Attitude Questionnaire - ITAQ (McEvoy 1989) The ITAQ is a 11-item semi-structured interview that measures awareness of illness and attitude to medication and services, as well as follow-up evaluation. Its scores range from 0 to 22, with high scores indicating better insight. Two studies reported data from this scale. 6.5.2 The Scale to Assess Unawareness of Mental Disorder SAUMD (Amador 1994) There is a total of 20 questions in SAUMD. Score range one to five points, a high score prompts a poor understanding and attribution. One study reported data from this scale. 6.5.3 Understanding of medication questionnaire - UMQ ( Macpherson 1996) UMQ measures knowledge of antipsychotic treatment. Fourteen stem questions generate eight sub-scale knowledge scores, relating to factual information, treatment practice, treatment rationale, effects of stopping treatment, side effects, precautions, tardive dyskinesia and risk/benefit evaluation.The UMQ is an extended version of scales measuring knowledge of illness and treatment and knowledge of tardive dyskinesia. Total knowledge score is 35. Knowledge scoring 0 = no understanding and 35 = full understanding. One study reported data from this scale. One study reported skewed data from this scale. 6.5.4 Knowlege About Schizophrenia Questionnaire-KSQ( Falloon 1983) KSQ is used to measure knowledge of mental illness and treatment, comprising of two parts.The first part consists of six openended questions and the second part contains 14 multiple-choice questions.The scores range from 0 to 44. A higher score prompts a better understanding of schizophrenia-related knowledge.One study reported data from this scale.

6.6 Global state 6.6.1 Global Assessment of Functioning - GAF (APA 1994) The scale is a 90-point rating scale that assesses psychological, social and occupational functioning. GAF is included in DSMIII- R as axis V, but in spite of this there is little research on the reliability and validity of the instrument. A few reliability and validity assessments have been made, indicating that an acceptable interrater reliability can be attained and that modest validity in relation to a disability measure has been demonstrated. High scores indicate a better outcome. One study reported data from this scale. 6.6.2 Global Assessment Scale - GAS (Endicott 1976) GAS is a 0-100 point rating scale, a global measure of overall functioning and symptomatology. High scores indicate better functioning. One study reported data from this scale.

6.7 Expressed emotion

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6.7.1 Family Questionnaire - FQ (Feinstein 1989) The FQ is based on the Camberwell Family Interview and is a 20-item questionnaire developed to enable a less time-consuming evaluation of expressed emotion in relatives. It covers the two dimensions of criticism and emotional over-involvement and the items are scored on a four-point scale. The questionnaire is reliability tested and validated in the German language (Feinstein 1994 personal communication). One study reported skewed data using this scale. One study reported data using this scale.

6.9 Missing outcomes Most studies reported outcomes of interest as specified in our protocol; however, some relevant outcomes of significance were either not measured or not reported, including global state outcomes, specific or general adverse events or effects, and changes in behaviour. Economic outcomes, which would be of particular interest regarding the nature of the intervention, were either not reported or not measured in the studies and references we obtained. Excluded studies

6.8 Satisfaction with care 6.8.1 Verona Service Satisfaction Scale - VSSS (Ruggeri 1993) The scale consists of 54 items in versions for patients and relatives. It is a questionnaire that covers seven dimensions of satisfaction with service: overall satisfaction, professionals’ skills and behaviour, information, access, efficacy, types of intervention and relatives’ involvement. (Ruggeri 1996) The VSSS satisfaction ratings are given on a five-point Likert scale. The instrument has been validated in community psychiatric samples (Ruggeri 1994; Ruggeri 1996). One study reported data from this scale. 6.8.2 Client Satisfaction Questionnaire-8 - CSQ-8 (Nguyen 1983) The CSQ-8 consists of eight items selected from the preliminary CSQ scale (Larsen 1979), which comprises 31 items in total.The eight questions could obtain a minimum score of eight to a maximum score of 32. A higher score will indicate a higher level of satisfaction. One study reported data from this scale.

In total, 19 studies were excluded with reasons, including non-randomised studies, irrelevant interventions, or no identifiable usable data. These studies are best inspected by viewing Characteristics of excluded studies. Awaiting assessment Eighteen studies are await assessment - descriptions of these studies can be found in Characteristics of studies awaiting classification. Ongoing Studies There are currently no ongoing studies that we are aware of.

Risk of bias in included studies See Figure 2 and Figure 3 as well as Characteristics of included studies for details as to each study’s ’Risk of bias’ assessment.

Figure 2. ’Risk of bias’ graph: review authors’ judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3. ’Risk of bias’ summary: review authors’ judgements about each risk of bias item for each included study.

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Allocation Overall, the majority of included studies were rated as a ’low’ risk of bias regarding random sequence generation, with 55% providing adequate detail regarding randomisation procedures. Methods of randomisation included computer-generated programmes (Group - Bechdolf 2004), central and independent randomisation at each study site in a multi-centre study (Group - Bauml 2007), drawing lots (Group - Chan 2009), as well as stratified random sampling (Group - Coyle 1988). The remaining 45% of studies were rated as ’unclear’ where the word ’randomised’ was stated but no further details were provided. Allocation concealment was generally rated as an ’unclear’ risk among the majority of the studies (75%), with the remaining providing description as to allocation concealment procedures permitting a rating of ’low’ risk of bias (25%).

continuous data from rating scales) (Both - Tom 1989; Group - Chan 2009; Group - Dai 2007) and inconsistency in reported participant numbers between multiple publications of the same study (Group - Bechdolf 2004).

Other potential sources of bias The majority of included studies were rated as a ’low’ risk of bias on this domain (60%); only one study was rated as a ’high’ risk (Group - Razali 1995), as participants in the control group received an unequal amount of therapist time than the intervention group. Only two studies provided details as to sources of funding, which was generally medical research council-funded, one in Germany (Group - Bauml 2007) and one in the UK (Individual - Cunningham 2001).

Blinding

Effects of interventions

Blinding of participants and outcome measures were largely rated as an ’unclear’ risk of bias across the two domains - only one included study mentioned blinding procedures (Group - Merinder 1999), which specified that outcomes were assessor-blinded. Due to the nature of the intervention, we were not anticipating studies to be double blind; however, there was lack of information as to whether raters were blinded as to allocation of intervention for purposes of rating outcomes such as compliance, relapse and other continuous measures.

See: Summary of findings for the main comparison ANY FORM OF BRIEF PSYCHOEDUCATION compared with for ROUTINE CARE/INFORMATION; Summary of findings 2 ANY FORM OF BRIEF PSYCHOEDUCATION compared with CBT for people with serious mental illness We calculated risk ratios (RR) for dichotomous data and estimated mean differences (MD) for continuous data, with their respective 95% confidence intervals (CIs).

Incomplete outcome data Generally, outcome-reporting was consistent and well-reported in 50% of the included studies rated as a ’low’ risk of bias, with 15% rated as an ’unclear’ risk where numbers leaving the study early were not made clear or no mention was made in the study report. The remaining 35% were rated as a ’high’ risk of bias on this domain, which included where a study did not state reasons for participants leaving the study early (Group - Aguglia 2007; Group - Bauml 2007), where participants leaving the study early were not considered (Group - Hornung 1995), or where such participants were expressly excluded from analysis (Group - Li 2003). Selective reporting The majority of studies were rated as a ’low’ risk of bias on this domain (60%), with outcomes generally well-reported. Those rated at an unclear risk (20%) included for reasons such as lack of thorough reporting of continuous outcome measures, i.e. no standard deviations (Group - Aguglia 2007; Group - Coyle 1988). The remaining 20% were rated as a ’high’ risk of bias for reasons including no presentation of pre-specified outcome measures (largely

COMPARISON 1: ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION

1.1 Compliance: 1a. With medication - non-compliance

1.1.1 short term In this subgroup we found three relevant trials (n = 448). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (RR 0.63 CI 0.41 to 0.96).

1.1.2 medium term In this subgroup we only found one relevant trial (n = 118) (Both Liu 2004). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (RR 0.17 CI 0.05 to 0.54).

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1.2 Compliance: 1b. With medication - partial compliance (medium term)

1.5.2 short term - received intervention but left the study early

In this subgroup we only found one relevant trial (n = 118) (Both - Liu 2004). There was no significant difference between any form of psychoeducation and routine care/information (RR 0.68, CI 0.39 to 1.18, Analysis 1.2).

In this subgroup we only found one relevant trial (n = 67) (Individual - Macpherson 1996). There was no significant difference between any form of psychoeducation and routine care/information (RR 3.06, CI 0.17 to 56.70).

1.3 Compliance: 1c.With medication - continuous outcomes (numeric compliance scale, data skewed)

1.5.3 medium term - loss to follow-up for any reason

Data for this outcome from one study were skewed, and are best inspected by viewing Analysis 1.3.

In this subgroup we found four relevant trials (n = 322). With assumption data, there was no significant difference between any form of psychoeducation and routine care/information (RR 0.74 CI 0.50 to 1.09).

1.4 Compliance: 1d. With medication - very good/good compliance

1.5.4 long term - loss to follow-up for any reason (by one year)

1.4.1 Medium term In this subgroup we only found one relevant trial (n = 236) (Group - Bauml 2007). There was no statistically significant difference between psychoeducation and routine care/information group. (RR 1.05 CI 0.93 to 1.18).

1.4.2 Long term by one year In this subgroup we only found one relevant trial (n = 236) (Group - Bauml 2007). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (RR 1.39 CI 1.16 to 1.66).

1.4.3 Long term by two years In this subgroup we only found one relevant trial (n = 236) (Group - Bauml 2007). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (RR 1.46 CI 1.20 to 1.76).

1.5 Compliance: 2a. With follow-up - loss to follow-up for any reason

In this subgroup we only found two relevant trials (n = 386) (Group - Aguglia 2007; Group - Bauml 2007). There was no significant difference between any form of psychoeducation and routine care/ information (RR 1.19, CI 0.83 to 1.72)

1.5.5 long term - loss to follow-up for any reason (by two years) In this subgroup we only found two relevant trials (n = 387) (Group - Bauml 2007; Group - Hornung 1995). There was no significant difference between any form of psychoeducation and routine care/ information (RR 0.83, CI 0.62 to 1.11).

1.5.6 long term - loss to follow-up for any reason (by five years or more) In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between any form of psychoeducation and routine care/information (RR 0.73, CI 0.44 to 1.21).

1.5.7 long term- received intervention but left the study early In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was a statistically significant (P = 0.05) difference favouring any form of psychoeducation over routine care/information (RR 0.58 CI 0.33 to 1.01).

1.6 Relapse: 1. Relapse for any reason

1.5.1 short term - loss to follow-up for any reason In this subgroup we only found one relevant trial (n = 30) (Both Tom 1989). There was no significant difference between any form of psychoeducation and routine care/information (RR 1.00, CI 0.24 to 4.18)

1.6.1 medium term In this subgroup we found four relevant trials (n = 406). There was a statistically significant difference (P = 0.01) favouring any

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form of psychoeducation over routine care/information (RR 0.70 CI 0.52 to 0.93).

1.10 Knowledge: 1c. Average endpoint (ITAQ, high = good, data skewed)

Data for this outcome from one study were skewed, and are best inspected by viewing Analysis 1.10. 1.6.2 long term In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between any form of psychoeducation and routine care/information (RR 0.85, CI 0.59 to 1.22)

1.6.3 long term (at five years follow-up) In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between any form of psychoeducation and routine care/information (RR 0.89, CI 0.73 to 1.08)

1.11 Knowledge: 2. Average endpoint scores(SAUMD, high = poor) (short term )

In this subgroup we only found one relevant trial (n = 81) (Group - Chan 2007). There was no statistically significant difference between any form of psychoeducation and routine care/information (MD -1.18, CI -2.46 to 0.10, Analysis 1.11)

1.12 Global state: 2. Average endpoint scale score

1.12.1 short term - (GAF/GAS, high = good) 1.7 Relapse: 2. Relapse with readmission

In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between any form of psychoeducation and routine care/information in the medium term (RR 0.85, CI 0.59 to 1.22) and long term (RR 0.83, CI 0.64 to 1.08) Analysis 1.7.

1.8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales

In this subgroup we only found one relevant trial (n = 41) (Group - Merinder 1999). There was no significant difference between any form of psychoeducation and routine care/information (MD -2.64, CI -12.74 to 7.46)

1.12.2 medium term - (GAF/GAS, high = good) In this subgroup we found two relevant trials (n = 101) (Group Hornung 1995; Group - Merinder 1999). There was no significant difference between any form of psychoeducation and routine care/ information (MD -0.50, CI -5.48 to 4.47). This subgroup had important levels of heterogeneity (Chi2 = 2.4; df = 1; P = 0.122; I2 = 58%).

1.8.1 short term (ITAQ, high = favourable)

1.12.3 long term - (GAS, high = good) - at two years

In this subgroup we found two relevant trials (n = 97) (Group Chan 2009; Both - Tom 1989). There was a statistically significant difference (P < 0.00001) favouring any form of psychoeducation over routine care/information (MD 7.39 CI 4.94 to 9.83).

In this subgroup we only found one relevant trial (n = 59) (Group - Hornung 1995). There was a statistically significant difference favouring routine care/information over any form of psychoeducation (MD -6.70 CI -13.38 to -0.02).

1.8.2 medium term (ITAQ, high = favourable)

1.12.4 long term - (GAS, high = good) - at five years or more

In this subgroup we only found one relevant trial (n = 73) (Group Chan 2009). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (MD 4.83 CI 1.51 to 8.15).

In this subgroup we only found one relevant trial (n = 60) (Group - Hornung 1995). There was no statistically significant difference between any form of psychoeducation and routine care/information (MD -3.80, CI -8.04 to 0.44).

1.13 Service utilisation: rehospitalisation 1.9 Knowledge: 1b. Average change (UMQ, high = good, data skewed)

Data for this outcome from one study were skewed, and are best inspected by viewing Analysis 1.9.

We found two relevant trials (n = 188). There was no significant difference between any form of psychoeducation and routine care/ information in the medium term (RR 0.88 CI 0.43 to 1.79) and long term (one trial, n = 141, RR 0.05 CI 0.51 to 1.00).

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1.14 Mental state: 1a. Global - continuous - average total endpoint scale scores (BPRS, high = poor)

1.18.2 depression - SDS

1.14.1 short term

In this subgroup we only found one relevant trial (n = 146) (Both - Zhang 2004). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (MD -7.62 CI -10.91 to -4.33).

In this subgroup we only found one relevant trial (n = 60) (Group - Zhang 2006). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (MD -2.70 CI -4.84 to -0.56).

1.19 Mental state: 2b. Specific - continuous - average endpoint scores (MADRS, high = poor, data skewed)

1.14.2 medium term

Data for this outcome from one study were skewed, and are best inspected by viewing Analysis 1.19.

In this subgroup we only found one relevant trial (n = 120) (Group - Li 2003). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (MD -5.36 CI -6.77 to -3.95).

1.20 Social functioning: 1a. Average change scores on various scales - medium term (high = poor)

1.15 Mental state: 1b. Global - continuous - average change scale scores (GWB/SES, high = good) (medium term)

1.20.1 rehabilitation status - MRSS

We only found one relevant trial (n = 118) (Both - Liu 2004). There was a statistically significant difference favouring any form of psychoeducation over routine care/information for both general well-being (MD 10.89 CI 9.82 to 11.96) and self-esteem(MD 8.00 CI 7.77 to 8.23) Analysis 1.15.

In this subgroup we only found one relevant trial (n = 118) (Both Liu 2004). There was a statistically significant difference favouring routine care/information over any form of psychoeducation (MD -13.68 CI -14.85 to -12.51).

1.16 Mental state: 1c. Global - continuous - average total endpoint scale scores (BPRS, high = poor, data skewed)

1.20.2 social disability - SDSS

Data for this outcome from two studies were skewed, and are best inspected by viewing Analysis 1.16.

1.17 Mental state: 2a. Specific symptoms - binary - specific symptoms - short term

We only found one relevant trial (n = 146) (Both - Zhang 2004). There was a statistically significant difference favouring any form of psychoeducation over routine care/information for anxiety (RR 0.49 CI 0.25 to 0.93) and depression (RR 0.47 CI 0.25 to 0.88) Analysis 1.17

1.18 Mental state: 2a. Specific symptoms - specific symptoms - short term

1.18.1 anxiety - SAS In this subgroup we only found one relevant trial (n = 146) (Both - Zhang 2004). There was a statistically significant difference favouring any form of psychoeducation over routine care/information (MD -6.11 CI -9.24 to -2.98).

In this subgroup we only found one relevant trial (n = 118) (Both Liu 2004). There was a statistically significant difference favouring routine care/information over any form of psychoeducation (MD -1.96 CI -2.09 to -1.83).

1.21 Expressed emotion (EE): Participants with high EE relatives (FQ)

1.21.1 short term - at end of interventions In this subgroup we only found one relevant trial (n = 46) (Group Merinder 1999). There was no significant difference between any form of psychoeducation and routine care/information(RR 0.65, CI 0.37 to 1.16)

1.21.2 medium term Data from the same trial found no significant difference between any form of psychoeducation and routine care/information (n = 46, RR 1.07, CI 0.64 to 1.78).

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1.22 Expressed emotion for relatives: Average Change scores on FQ scales (high = good) (short term - at end of interventions)

Only one trial reported the change of expressed emotion for relatives of schizophrenia patients. Result showed that there is no significant difference between any form of psychoeducation and routine care (n = 29, MD -3.25, CI -8.24 to 1.74, Analysis 1.22). 1.23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = favourable)

In this subgroup we only found one relevant trial (n = 62) (Group Lv 2007). There was no significant difference between any form of psychoeducation and routine care/information in the short term (MD 0.63, CI -0.79 to 2.05), but a statistically significant difference favouring any form of psychoeducation over routine care/ information in the medium term (MD 2.13 CI 1.03 to 3.23). Analysis 1.23

1.27 Satisfaction with mental health services: 2. Average change - at one year (VSS Scale, high = good)

1.27.1 patients’ satisfaction with relatives’ involvement mean change In this subgroup we only found one relevant trial (n = 30) (Group - Merinder 1999). There was a statistically significant difference favouring routine care/information over any form of psychoeducation (MD -4.35 CI -7.09 to -1.61).

1.27.2 relatives’ involvement satisfaction In the same trial (n = 21) (Group - Merinder 1999), there was no significant difference between any form of psychoeducation and routine care/information .(MD -2.17, CI -6.11 to 1.77)

1.27.3 relatives’ efficacy satisfaction 1.24 Quality of life: 1b. Average endpoint scores (FAD, high = poor)

In this subgroup we only found one relevant trial (n = 62) (Group Lv 2007). There was no significant difference between any form of psychoeducation and routine care/information in the short term (MD -0.42, CI -5.45 to 4.61), but a statistically significant difference was found favouring any form of psychoeducation over routine care/information (MD -6.79 CI -11.67 to -1.91). Analysis 1.24 1.25 Quality of life: 1c. Average endpoint scores (FBIS, high = poor, data skewed)

In the same trial (n = 24) (Group - Merinder 1999), there was no significant difference between any form of psychoeducation and routine care/information (MD -2.16, CI -7.29 to 2.97).

1.27.4 relatives’ intervention satisfaction In the same trial (n = 26) (Group - Merinder 1999), there was no significant difference between any form of psychoeducation and routine care/information .(MD -3.43, CI -9.83 to 2.97)

1.28 Patients’ satisfaction with mental health services: average endpoint scores - short term (CSQ, high = good)

Data for this outcome from one study were skewed, and are best inspected by viewing Analysis 1.25 .

In this subgroup we only found one relevant trial (n = 24) (Both Tom 1989). There was no significant difference between any form of psychoeducation and routine care/information Analysis 1.28.

1.26 Satisfaction with mental health services: 1.Average change score - short term (VSS Scale/CSQ, high = good)

1.29 Adverse event: Death

1.26.1 patients’ satisfaction

1.29.1 medium term

In this subgroup we only found one relevant trial (n = 32) (Group - Merinder 1999 ). There was no significant difference between any form of psychoeducation and routine care/information (MD -2.15, CI -13.96 to 9.66)

In this subgroup we found two relevant trials (n = 154) (Group Merinder 1999; Individual - Nasr 2009). There was no significant difference between any form of psychoeducation and routine care/ information (RR 0.99, CI 0.15 to 6.65) .

1.26.2 relatives’ satisfaction

1.29.2 long term

In this subgroup we only found one relevant trial (n = 17) (Group - Merinder 1999). Again, there was no significant difference between any form of psychoeducation and routine care/information (MD -10.81, CI -32.22 to 10.60).

In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between any form of psychoeducation and routine care/information (RR 0.85, CI 0.05 to 13.30).

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Comparison 2: ANY FORM OF BRIFE PSYCHOEDUCATION versus Cognitive Behavourial Therapy (CBT)

2.1 Compliance: 1b. With medication (numeric compliance scale, high = good)

In this subgroup we only found one relevant trial (Group Bechdolf 2004). There was no statistically significant difference between any form of psychoeducation and routine care/information at either short term (n = 88, MD -0.20, CI -0.42 to 0.02), medium term (n = 88, MD -0.30, CI -0.70 to 0.10), nor long term (n = 41, (MD -0.50, CI -1.05 to 0.05, Analysis 2.1).

3.1.1 group - short term In this subgroup we found two relevant trials (n = 162). There was no statistically significant difference between group psychoeducation and routine care/information (Analysis 3.1).

3.1.2 unclear - short term We identified one relevant trial in this subgroup (n = 286, Unclear - Li 2005). There was no statistically significant difference between either group psychoeducation or individual psychoeducation (unclear) and routine care/information (Analysis 3.1).

3.1.3 both - medium term 2.2 Relapse: Relapse for any reason (medium term)

There is no statistical difference between brief psychoeducation and CBT for this outcome in the medium term (n = 88, RR1.67, CI 0.62 to 4.48, Analysis 2.2), however this no difference may due to the wide confidence interval resulting from the small sample size. 2.3 Service utilisation: hospitalisation (long term)

There is no statistical difference between brief psychoeducation and CBT for this outcome in the long term (n = 43, RR1.58, CI 0.78 to 3.20, Analysis 2.3). In the same case with relapse, this no difference may due to the wide confidence interval. 2.4 Mental state: Specific - continuous - average endpoint PANSS scores (high = poor)

We only found one relevant trial (n = 88) (Group - Bechdolf 2004). There was no significant difference between any form of psychoeducation and routine care/information in the short or medium term, nor in the long term (n = 41). Analysis 2.4

In this subgroup we only found one relevant trial (n = 118) (Both Liu 2004). There was a statistically significant difference favouring psychoeducation delivered either via group or individually (’both’) over routine care/information (RR 0.17 CI 0.05 to 0.54, Analysis 3.1).

3.2 Compliance: 1b. With follow up - loss to follow-up for any reason

3.2.1 both - short term - loss to follow-up for any reason In this subgroup we only found one relevant trial (n = 30) (Both - Tom 1989). There was no significant difference between group psychoeducation and routine care/information (Analysis 3.2).

3.2.2 group - medium term - loss to follow-up for any reason In this subgroup we found three relevant trials (n = 208). There was no significant difference between group psychoeducation and routine care/information (Analysis 3.2).

2.5 Quality of life - Average endpoint MSQoL-54 score

In this subgroup we only found one relevant trial (n = 63) (Group - Bechdolf 2004). There was no significant difference between any form of psychoeducation and routine care/information in the short term (MD 1.80, CI -10.17 to 13.77) or medium term (n = 64, MD 4.50, CI -6.66 to 15.66). Analysis 2.5 SUBGROUP ANALYSES 3. GROUP PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION versus ROUTINE CARE/INFORMATION

3.1 Compliance: 1a. With medication - non-compliance

3.2.3 individual - medium term - loss to follow-up for any reason In this subgroup we only found one relevant trial (n = 114) (Individual - Cunningham 2001). There was no significant difference between individual psychoeducation and routine care/information (Analysis 3.2).

3.2.4 group - long term - loss to follow-up for any reason (by one year) In this subgroup we found two relevant trial (n = 386) (Group Aguglia 2007). There was no significant difference between group psychoeducation and routine care/information (Analysis 3.2).

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3.2.5 group - long term - loss to follow-up for any reason (by two years) In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between group psychoeducation and routine care/information (Analysis 3.2).

3.2.6 group - long term - loss to follow-up for any reason (by five years or more) In this subgroup we only found one relevant trial (n = 124) (Group - Hornung 1995). There was no significant difference between group psychoeducation and routine care/information (Analysis 3.2).

3.3 Relapse: 1. Relapse for any reason

4.1.1 Compliance: With medication - non-compliance After excluding studies with high risk of bias assessment, no data are left to compare in this outcome (Both - Liu 2004; Group - Dai 2007; Group - Zhang 2006; Unclear - Li 2005).

4.1.2 Compliance: With follow up - loss to follow-up for any reason There is no difference in the estimate of the effect in data analyses when the one study that implied randomisation was removed from synthesis (Group - Aguglia 2007).

4.1.3 Relapse: Relapse for any reason After removing the two studies that merely implied randomisation from data synthesis (Group - Chan 2007; Group - Razali 1995), there is no significantly difference in the estimate of effect.

3.3.1 group - medium term

4.2 Assumptions for lost binary data

In this subgroup we found 3 relevant trials (n = 292). There was no statistically significant difference between group psychoeducation and routine care/information. (RR 0.72 CI 0.51 to 1.02, Analysis 3.3).

4.2.1 Compliance: With medication - non-compliance

3.3.2 individual - medium term We found one relevant trial in this subgroup (n = 114, Individual - Cunningham 2001). There was no significant difference between individual psychoeducation and routine care/information (Analysis 3.3).

3.3.3 group - long term In this subgroup we only found one relevant trial (n = 124, Group - Hornung 1995). There was no significant difference between group psychoeducation and routine care/information (Analysis 3.3).

3.3.4 group - long term (at five years follow-up) In this subgroup we only found one relevant trial (n = 124, Group - Hornung 1995). There was no significant difference between group psychoeducation and routine care/information (Analysis 3.3)

4. SENSITIVITY ANALYSIS

4.1 Implication of randomisation

There was no difference in the estimate of the effect when our assumptions were replaced with completer-only data.

4.2.2 Compliance: With follow-up - loss to follow-up for any reason There was no difference in the estimate of the effect when our assumptions were replaced with completer-only data.

4.2.3 Relapse: Relapse for any reason There is no missing data for the primary outcomes in comparison 1; For comparison 2, there is no difference between brief psychoeducation and CBT for relapse after removing the assumptions (Group - Bechdolf 2004, Analysis 4.1)

4.3 Risk of bias

4.3.1 Compliance: With medication - non-compliance After removing the two studies that were rated as a ’high’ risk of bias across one or more of the risk of bias domains from data synthesis (Group - Dai 2007; Unclear - Li 2005), results were no longer significantly in favour of brief psychoeducation in the short term, and instead demonstrating no difference between groups (n = 60, RR 0.67, CI 0.12 to 3.71) Analysis 5.1. However, this nonsignificance is more likely due to the small sample size resulting in a wider confidence interval.

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4.3.2 Compliance: With follow-up - loss to follow-up for any reason There was no difference in the estimate of the effect when studies that were rated as a ’high’ risk of bias across one or more of the risk of bias domains were removed from synthesis.

4.5 Fixed and random effects

4.5.1 Compliance: With medication - non-compliance There was no difference in the estimate of the effect when a random-effects model was used for data synthesis instead of a fixedeffect model.

4.3.3 Relapse: Relapse for any reason After removing the two studies that were rated as a ’high’ risk of bias across one or more of the risk of bias domains from data synthesis (Group - Bechdolf 2004; Group - Razali 1995), there was no difference in the estimate of the effect.

4.5.2 Compliance: With follow-up - loss to follow-up for any reason There was no difference in the estimate of the effect when a random-effects model was used for data synthesis instead of a fixedeffect model.

4.4 Imputed values

We had planned to undertake a sensitivity analysis to assess the effects of including data from trials where we used imputed values for ICC in calculating the design effect in cluster-randomised trials. however, no cluster-randomised trials were identified.

4.5.3 Relapse: Relapse for any reason There was no difference in the estimate of the effect when a random-effects model was used for data synthesis instead of a fixedeffect model.

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Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

A D D I T I O N A L S U M M A R Y O F F I N D I N G S [Explanation]

ANY FORM OF BRIEF PSYCHOEDUCATION compared with CBT for people with serious mental illness Patient or population: patients with people with serious mental illness Settings: Intervention: ANY FORM OF BRIEF PSYCHOEDUCATION Comparison: CBT Outcomes

Compliance: With medication (numeric compliance scale, high = good) - short term Follow-up: up to 12 weeks

Illustrative comparative risks* (95% CI)

Assumed risk

Corresponding risk

CBT

ANY FORM OF BRIEF PSYCHOEDUCATION

The mean compliance: with medication in the control groups was 3.9 points.

The mean compliance: with medication (numeric compliance scale, high = good) - short term in the intervention groups was 0.2 lower (0.42 lower to 0.02 higher)

Relapse: Relapse for any Study population reason (medium term) Follow-up: 12-52 weeks 125 per 10004

RR 1.67 (0.62 to 4.48) 209 per 1000 (78 to 560)

Moderate 125 per 10004

Relative effect (95% CI)

209 per 1000 (78 to 560)

No of Participants (studies)

Quality of the evidence (GRADE)

88 (1 study)



very low1,2,3

88 (1 study)



very low1,2,3

Comments

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Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Mental state: 2b. Specific - average endpoint PANSS scores (high = poor) - short term - positive score Follow-up: up to 12 weeks

The mean mental state: average positive score in the control groups was 11.3 points.

The mean Mental state: specific- average endpoint PANSS scores (high = poor)-short term-positive score in the intervention groups was 0.10 higher (1.72 lower to 1.92 higher)

88 (1 study)



very low1,2,3

Quality of life: 1a. Average endpoint scores on various scales (MSQoL54, high = good) - short term Follow-up: up to 12 weeks

The mean quality of lifeshort term in the control groups was 52.8 points.

The mean Quality of life: average endpoint scores on various scales- short term in the intervention groups was 1.80 higher (10.17 lower to 13.77 higher)

63 (1 study)



very low1,2,3

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; CBT: Congnetive Behavoural Therapy. GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 2 3 4

Risk of bias: rated ’serious’ - one included study rated as a ’high’ risk of bias across two of the ’Risk of bias’ domains, including incomplete outcome data and selective reporting. Imprecision: rated as ’serious’, too small sample size. We strongly suggested a publication bias because only one studies was included. Assumed risk: median control group risk presented from studies, as little variation in baseline risk across studies (12.5%).

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DISCUSSION

Summary of main results 1. ANY FORM OF BRIEF PSYCHOEDUCATION versus ROUTINE CARE/INFORMATION See Summary of findings table 1 for grading of the quality of the evidence relating to our primary outcomes of interest. 1.1. Compliance Based on our results, compliance with medication was shown to be significantly better in participants receiving psychoeducation, with significantly fewer people receiving psychoeducation not complying with their medication regimen in the short term based on a sample size of n =448. This may produce attrition and reporting bias on the result. This significant benefit also extended to the medium term. The sensitivity analysis also shows that more rigorous studies with large sample size are required. However, as regards the majority of our primary outcome measures of compliance is concerned, there was no difference in the estimate of the effect for levels of compliance measured using continuous rating scales, nor partial non-compliance. This conclusion is not robust due to the sparse data, and the wide confidence interval for overall effect also demonstrated the result as lack of precision. Furthermore, significant outcomes have been identified across degrees of compliance (i.e. ’very good compliance’ significantly in favour of brief psychoeducation) at one-year and two-year follow-up. As regards compliance with follow-up, there seemed to be no significant difference between groups for those lost to follow-up by medium term (n = 322), by one year (n = 386) and bytwo2 years (n = 387). Fewer participants in the psychoeducation group left the study early after receiving the intervention than those in routine care group. For short-term compliance with follow-up, the results showed no significance between groups; however, this is likely due to the sparse data resulting in a wide confidence interval, more data for this outcome should be reported in the future studies. 1.2. Relapse By replacing assumptions with completer-only data, relapse was significantly greater by medium term amongst participants receiving routine or standard care (n = 406); the quality of evidence is moderate because of serious risk of bias across studies. However longer-term follow-up (at one and five years) demonstrated no difference (n = 124). The small sample size indicates an inaccuracy of the result. The result is also likely to be confounded with performance bias, detection bias and reporting bias. As it stands with the current data, it is unclear how effective any form of brief psychoeducation is compared with routine/standard care - particularly for the longer term.

1.3. Knowledge Again, skewed data draws uncertainty onto any results due to uneven distribution - therefore, where results are descriptively stated in ’other tables’, data are not pooled with similar outcomes. Such skewed data needs interpreting with caution. With what we could use from the included studies, sample sizes were too small to detect any meaningful significance in the results; data from the (Insight Treatment Attitude Questionnaire) (ITAQ) scale does indicate a trend that people receiving brief psychoeducation have significantly better knowledge and understanding of the illness, again to be read in the light of the small study population (n = 97). The result may also be affected by attrition bias and selective reporting. 1.4. Global state Follow-up data at long-term (at two years) using the Global Assessment Scale (GAS) significantly favoured the psychoeducation group, but results are from a small sample size (n = 59). Other data from the Global Assessment of Functioning (GAF) or GAS demonstrated no significant difference. A consistent approach to recording data would greatly help understand findings. Due to a serious risk of bias, inconsistency and imprecision, the quality of evidence is very low. One included study was rated as high risk due to incomplete data. This may induce serious attrition bias to the result. A wide confidence interval of the overall effect also impacts the precision of the result. 1.5. Service utilisation Only two studies provided data on this important outcome, which could provide a level of understanding regarding service utilisation and associated resource use - an important factor when considering economic viability of the intervention. Data demonstrate no significant difference between groups; the result may be underpowered because of too small sample size. 1.6. Mental state Generally, studies indicated a greater improvement for participants in the psychoeducation group compared with those allocated to standard care, but the differences in overall reduction were small, and the clinical significance of a difference of this magnitude may be questioned. The quality of evidence was rated as low because of serious imprecision and strongly detected publication bias. One study (n = 118) demonstrated a better general well-being and selfesteem in the psychoeducation group rather than the routine care group. The reliability of this result may be compromised by the small sample size and unclear risk of bias across most of domains. Only one study reported the outcome on specific mental state symptoms of anxiety and depression (Both - Zhang 2004); results suggested that less participants in the psychoeducation group suffered from these symptoms and that brief psychoeducation can

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decrease the level of both symptoms. As with all findings from a few small studies, these findings should be replicated before being considered reliable and conclusive.

1.7. Social functioning Results from one small study supported that brief psychoeducation can improve the patients social function such as rehabilitation status and social disability; because of the small sample size (n = 118) of the only included study, this result has serious imprecision and this positiveness is likely ascribe to publication bias. So the quality of evidence was downgraded and rated as low.

1.8. Expressed emotion The one study that provided data for this outcome (n = 46, Group - Merinder 1999) did not demonstrate and significant differences between groups. Without more data, it is difficult to conclude if psychoeducation is indeed better than standard care on reducing expressed emotion in relatives.

1.9. Quality of life Data tended to favour the brief psychoeducation group in medium-term improvement for quality of life. although measured by two different scales. The short-term quality of life is similar between groups. Consistency of measures and more data are needed before confidence can be drawn on the effects of brief psychoeducation and quality of life. Because of a small sample size (n = 62), imprecise result and suspected publication bias, the quality of evidence was rated as very low.

2.ANY FORM OF BRIEF PSYCHOEDUCATION versus Cognitive Behavourial Therapy (CBT) Only one study provided data for this comparison, there is no statistical difference between psychoeducation and CBT for compliance, relapse, hospitalisation, mental state and patients’ quality of life. The quality of the evidence is very low because of serious risk of bias, wide confidence interval and suspected publication bias. However, this result may not indicate a similar effect between the two groups, but may be caused by the small sample size resulting in a wide confidence interval. So more data are required to compare the difference between brief psychoeducation and CBT.

3. SUBGROUP ANALYSIS: GROUP PSYCHOEDUCATION/ INDIVIDUAL PSYCHOEDUCATION versus ROUTINE CARE/INFORMATION Indirect comparisons of the 13 studies that provided data for our primary outcomes of interest were undertaken, comparing any difference in the estimate of effect with either individual brief psychoeducation versus group brief psychoeducation. These findings were, however, not direct comparisons, and were not well powered and serve only to generate theories for future studies.

3.1 Compliance We found no convincing evidence that those given psychoeducation in a group differed in terms of compliance with those where the intervention was delivered individually. However, the one study that delivered the intervention ’both’ as a group and individually did demonstrate statistical significance in favour of brief psychoeducation in the medium term (n = 118, Both - Liu 2004). Again, these results serve as an indirect comparison, with no definitive conclusions to be drawn just yet.

1.10. Satisfaction with care All data for levels of satisfaction with care derive from only one of the included studies (n = 46, Group - Merinder 1999); data indicated an equivocal effect between groups. This is an important outcome, and much more data are needed to understand how psychoeducation really effects this outcome.

3.2 Relapse Group-delivered brief psychoeducation can result in an short-term improvement for relapse, however this improvement was not observed in either the long-term measurement nor in individual-delivered psychoeducation. This may due to the insufficient data, more data should be collected before a definitive conclusion.

1.11. Adverse events: death Across the time periods of the few studies that reported on this outcome (about two years), approximately 1% of people died. There was no suggestion that psychoeducation had any effect on this outcome.Two included studies were rated as high risk in the domain of “blinding” and “incomplete data”.These may introduce performance or detection bias. Coupled with a wide confidence interval which indicates a imprecise result, the quality of evidence was downgraded as low.

4. Sensitivity analysis

4.1 Implication for randomisation There is no significant difference by removing the studies that implied randomisation (Group - Chan 2007; Group - Razali 1995), which means that the randomisation of included studies was acceptable and did not generate further bias.

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4.2. Asumption for lost binary data

Quality of the evidence

Apart from relapse rate for any reason, there is no significant difference between the assumed data and completer-only data, which means that the assumed data were acceptable and did not produce further bias (Analysis 4.1).

Overall, the quality of reporting was low; half of the included studies did not describe how the randomisation was conducted. Blinding was only mentioned in one study and blinding concealment was not tested. Therefore, there is a moderate risk of overestimating the estimate of effect. For some outcomes, imprecision and publication bias were considered serious enough to warrant downgrading quality of evidence. Please refer to Figure 2 and Figure 3 for a graphic representation of the methodological quality of included studies. The quality of evidence gradings for main outcomes of interest are also presented in Summary of findings for the main comparison and Summary of findings 2.

4.3.Risk of bias After removing studies with a high risk of bias, there were no longer significant differences between brief psychoeducation and routine care groups in short-term compliance to medication and relapse rate. Based on the values of overall effect and confidence intervals, we attribute these disagreements to the decrease of total sample size (from n = 448 to n = 60) (Analysis 5.1).

Potential biases in the review process 4.4 Fixed and random effects There was no difference in the estimate of the effect when a random-effects model was used for data synthesis instead of a fixedeffect model in compliance and other outcomes, which means that fixed random effects is acceptable for the data analysis.

Overall completeness and applicability of evidence

1. Completeness As regards our primary outcomes of interest, most included studies reported data for compliance, with just under half reporting on the outcome of relapse. More binary data and less, or even more consistently-reported, continuous data would be widely welcomed for a review such as this - it difficult to make concrete decisions as to the estimate of the effect when the evidence provided within study reports are inconsistent with each other. More data on participant satisfaction with services or care would be needed to accompany the other patient-oriented outcomes that this intervention seeks to provide. Policy makers will certainly want more and better reported economic data. 2. Applicability Most trials were undertaken in hospital, whereas the majority of people with schizophrenia are treated in the community. We are unsure that, in the context of well-functioning community services, psychoeducation, as a separate package, has a place. This is the sort of information that would not be difficult to generate. As regards a context in which fully-functioning community services do not exist, further evidence is needed from such countries and contexts in order to clarify how far a brief psychoeducation package would be effectively received, in terms of compliance with medication, relapse and other global state outcomes.

The process of searching for studies was thorough. We strictly followed the review protocol in the process of study selection, data extraction and analysis. However, we only worked with published reports in this review and may be perpetuating a publishing bias. Half of the included studies were from the People’s Republic of China. The quality of some of the Chinese trials has been called into question (Wu 2006), as many that are stated to be randomised are not.

Agreements and disagreements with other studies or reviews This review largely concurs with findings from the previous related Cochrane review (Xia 2011).

AUTHORS’ CONCLUSIONS Implications for practice 1. For people with schizophrenia For schizophrenia patients in China, Germany, Denmark, Pakistan, Scotland and Malaysia, brief psychoeducation may improve short-term and medium-term compliance with medication as well as the degree of compliance with medication. Whether brief psychoeducation can improve the compliance with follow-up remains uncertain. In the medium term, brief psychoeducation can reduce the risk of relapse, but the long-term effect remains unclear because of insufficient evidence. The patients’ knowledge on schizophrenia may also be improved by brief psychoeducation. Insufficient data supported that brief psychoeducation: i) can improve the longterm global state; ii) has no effect for rehospitalisation; iii) can achieve a short-term and medium-term greater improvement for

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mental state; iv) has a better general well-being and self-esteem; and v) can lower the incidence and severity of anxiety and depression. Social function such as rehabilitation status and social disability were also improved by brief psychoeducation. A greater medium-term improvement of quality of life was also observed in the psychoeducation group; adverse events were similar between psychoeducation and routine care group. As far as this review is concerned, data from 20 studies are not strong enough to conclude with any certainty the benefits that may be received from participating in this therapy. Larger studies are needed to confirm or refute any benefit. Unreliable evidence supported that brief psychoeducation has similar effects with CBT for compliance, relapse, re-hospitalisation, mental state and quality of life.

2. For clinicians It is not possible to say with a degree of certainty the true benefits that people with schizophrenia will obtain from a brief psychoeducational approach. Evidence does suggest better compliance in the short term and lower relapse rates in the medium term with the intervention than without it; however, studies were not highlypowered enough, with small sample sizes and varying times in which the interventions were delivered, to confirm this.

2. Specific See Table 1 for a suggested design of future study, modified from that included in the full version of the Cochrane psychoeducation review (Xia 2011). The key difficulty in assessing the efficacy of a brief psychoeducational approach is the heterogeneity between studies regarding the delivered intervention. Surprisingly, heterogeneity was not found to be a huge problem in the results of this review; however, well-standardised brief psychoeducational programmes with clear definitions of the content of interventions to help professionals planning evidence-based psychoeducational interventions, people with schizophrenia and family members participating in psychoeducation programmes will go a long way to determining the true effect of this intervention. Furthermore, any continuous measures must be consistent, using internationally-recognised, peer-reviewed rating scales, and include full reports with means and standard deviations. It is clear that larger studies are needed, with more research into specific participant populations, including acute and treatment-resistant people with schizophrenia, as current evidence is lacking. It is also clear that economic evidence is tantamount, and comes hand-in-hand when considering efficacy of a new treatment in the treatment of serious mental illness. Table 2 also shows where excluded studies in this area could be included either in reviews already underway or in reviews for the future, which when complete can help provide an overview of research and evidence in this area.

3. For managers and policy makers Few data exist concerning the economic consequences of implementing brief psychoeducation as a routine service. More extensive economic research should be undertaken in this area to explore the true costs of the brief version of the intervention as compared to a longer version, to more accurately consider any cost-benefit.

ACKNOWLEDGEMENTS

1. General

The Cochrane Schizophrenia Group Editorial Base in Nottingham produces and maintains standard text for use in the Methods section of their reviews. We have used this text as the basis of what appears here and adapted it as required. The search term was developed by the Trial Search Co-ordinator of the Cochrane Schizophrenia Group and the contact author of the original protocol.

Adherence to CONSORT for good reporting of clinical trials more closely would have helped to considerably increase the amount of data available in this review.

We would like to thank Raija Kontio and Lilas Ali for peer reviewing this version of the review. Athfah Akhtar helped with data extraction of two included studies, we would like to acknowledge and thank her for her contribution.

Implications for research

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REFERENCES

References to studies included in this review Both - Liu 2004 {published data only} Liu L, Gao CF, Yue SY, Zhan LY, Liu WG. Effect of family intervention on rehabilitation of schizophrenic patients in community. Journal of Nursing Science 2004;3(19):3–6. Both - Tom 1989 {published data only} Tom L. Psychoeducational approach with chronically mentally ill Chinese-Americans: a cultural framework. PhD dissertation submitted to the City University of New York, USA 1989:161. Both - Zhang 2004 {published data only} Zhang L, Ren QL, Li CP, Yao N, Han FZ. Improvement of anxiety and depression in patients with schizophrenia at recovery stage via education of health conviction mode. Journal of Nursing Science 2004;19(15):51–3. Group - Aguglia 2007 {published data only} Aguglia E, Pascolo-Fabrici E, Bertossi F, Bassi M. Psychoeducational intervention and prevention of relapse among schizophrenic disorders in the Italian community psychiatric network. Clinical Practice and Epidemiology in Mental Health 2007;3:1745–79. Group - Bauml 2007 {published data only} Bauml J, Kissling W, Buttner P, Pitschel Walz G, Boerner R, Engel R, et al. Specific effects of psychoeducational groups on the relapse rates of schizophrenic patients. Pharmacopsychiatry 1995;28:161. Bauml J, Kissling W, Buttner P, Schlag K, Pitschel Walz G, Borner R, et al. Psychoeducational groups for schizophrenic patients and their relatives: influence on compliance, rate of rehospitalization and social functioning (PIP-study, Munchen). Pharmacopsychiatry 1993;26:140. Bauml J, Kissling W, Pitschel-Walz G. Psychoeducational groups among schizophrenic patients: Influence on knowledge and compliance. Results of the Munich PIP study. Nervenheilkunde 1996;15:145–50. Bauml J, Pitschel-Walz G, Kissling W. Group psychoeducation in schizophrenic psychoses. Psycho 1997; 23:38–45. ∗ Bauml J, Pitschel-Walz G, Volz A, Engel RR, Kessling W. Psychoeducation in schizophrenia: 7-year follow-up concerning rehospitalization and days in hospital in the Munich Psychosis Information Project Study. Journal of Clinical Psychiatry 2007;68:854–61. Pitschel-Walz G, Bauml J, Bender W, Engel R R, Wagner M, Kissling W. Psychoeducation and compliance in the treatment of schizophrenia: results of the Munich Psychosis Information Project Study. Journal of Clinical Psychiatry 2006;67:443–52. Pitschel-Walz G, Boerner R, Mayer C, Wagner M, Engel RR, Peuker I, et al. Effects of psychoeducational groups for schizophrenic patients and their relatives on knowledge, compliance and relapse. Pharmacopsychiatry 1995;28:204.

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psychoterapeutischer behandlung]. Fortschritte der Neurologie Psychiatrie 2000;68(2):54–60. Hornung WP, Buchkremer G, Redbrake M, Klingberg S. Patient modified treatment. What are the effects of neuroleptic drugs on people with schizophrenia? [Patientmodifizierte medikation: Wie gehen schizophrene patienten mit ihren neuroleptika um?]. Nervenarzt 1993; 64:434–9. Hornung WP, Feldmann R, Klingberg S, Buchkremer G, Reker T. Long term effects of a psychoeducational psychotherapeutic intervention for schizophrenic outpatients and their key persons: results of a five year follow-up. European Archives of Psychiatry and Clinical Neuroscience 1999;249:162–7. Hornung WP, Feldmann R, Schonauer K, Schafer A, Monking HS, Klingberg S, et al. Psychoeducational psychotherapeutic treatment of schizophrenic patients and their caregivers. II. Supplementary findings at a 2 year follow up. Der Nervenarzt 1999;70:444–9. ∗ Hornung WP, Holle R, Schulze Monking H, Klingberg S, Buchkremer G. Psychoeducational-psychotherapeutic treatment of schizophrenic patients and their caregivers. Results of a one-year catamnestic study. Der Nervenarzt 1995;66:828–34. Hornung WP, Kieserg A, Feldman R, Buchkremer G. Psychoeducational training for schizophrenic patients: background, procedure and empirical findings. Patient Education and Counseling 1996;29:257–68. Hornung WP, Klingberg S, Feldmann R, Schonauer K, Schulze Monking H. Collaboration with drug treatment by schizophrenic patients with and without psychoeducational training: results of a 1-year follow-up. Acta Psychiatrica Scandinavica 1998;97:213–9. Hornung WP, Schonauer K, Feldmann R, Monking HS. Medication-related attitudes of chronic schizophrenic patients. A follow-up study after psycho-educational intervention [Medikationsbezogene einstellungen chronisch schizophrener patienten. Eine follow–up untersuchung 24 monate nach psychoedukativer Intervention]. Psychiatrische Praxis 1998;25(1):25–8. Klingberg S, Buchkremer G, Holle R, Schulze-Monking H, Hornung WP. Differential therapy effects of psychoeducational psychotherapy for schizophrenic patients: results of a 2 year follow up. European Archives of Psychiatry and Clinical Neuroscience 1999;249(2):66–72.

Knowledge, Satisfaction With Services and Clinical Outcome in Schizophrenia. Faculty of Health Sciences, University of Aarhus, Department of Psychiatric Demography, Institute for Basic Psychiatric Research. Psychiatric Hospital in Aarhus, 2000. Merinder LB, Viuff AG, Laugesen H, Clemendsen K, Misfelt S, Espensen B. Effects of psychoeducative methods: a randomized controlled study. Nordisk Psykiatrisk Tidsskrift 1998;52:144. ∗ Merinder LB, Viuff AG, Laugesen HD, Clemmensen K, Misfelt S, Espensen B. Patient and relative education in community psychiatry: a randomized controlled trial regarding its effectiveness. Social Psychiatry and Psychiatric Epidemiology 1999;34:287–94. Merinder LB, Viuff AG, Laugesen HD, Clemmensen K, Misfelt S, Espensen B. Patient and relative education in community psychiatry; a randomised trial regarding its usefulness. Proceedings of the 9th Congress of the Association of European Psychiatrists; 1998 Sep 20-24; Copenhagen, Denmark. 1998. Group - Razali 1995 {published data only} ∗ Razali MS, Yahua H. Compliance with treatment in schizophrenia: a drug intervention program in a developing country. Acta Psychiatrica Scandinavica 1995;91:331–5. Razali SM, Yahua H. Health education and drug counselling for schizophrenia. International Medical Journal 1997;4(3): 187–9. Group - Zhang 2006 {published data only} Zhang H, Wang P, Wu Z. Influence of health education on compliance of orally taking medicines in schizophrenia patients of the first episode seeing doctor in out-patient clinic. Chinese Nursing Research 2006;20(5):1246–7. Individual - Cunningham 2001 {published data only} Cunningham Owens DG, Carroll A, Fattah S, Clyde Z, Coffey I, Johnstone EC. A randomized, controlled trial of a brief interventional package for schizophrenic out-patients. Acta Psychiatrica Scandinavica 2001;103(5):362–9. Individual - Macpherson 1996 {published data only} Macpherson R, Jerrom B, Hughes A. A controlled study of education about drug treatment in schizophrenia. British Journal of Psychiatry 1996;168:709–17.

Group - Li 2003 {published data only} Li FM, Xu JH. Comparative study on the effect of family intervention on schizophrenia patients in convalescence and their family members. Health Psychology Journal 2003;11 (2):129–30.

Individual - Nasr 2009 {published data only} Nasr T, Kausar R. Psychoeducation and the family burden in schizophrenia: a randomized controlled trial. Annals of General Psychiatry 2009;8:17.

Group - Lv 2007 {published data only} Lv C-M, Lu D-C, Lv W-Q, Jin L-Z, Zheng Q-L. Effects of follow- up on family function of schizophrenia patients’ families and their quality of life. Nanfang Journal of Nursing 2007;14(9):7–9.

Unclear - Li 2005 {published data only} Li H. Systematic psychoeducation for medication compliance in patients with schizophrenia. Journal of Qilu Nursing 2005;11(7B):897–8.

Group - Merinder 1999 {published data only} Merinder LB. Impact of Patient and Relative Education on

References to studies excluded from this review

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Carra 2010 {published data only} ∗ Carra G. Multiple group family treatment for schizophrenia in Italy. Schizophrenia Research 2010;117: 121. Carra G, Montomoli C, Clerici M, Cazzullo CL. Family interventions for schizophrenia in Italy: randomized controlled trial. European Archives of Psychiatry and Clinical Neuroscience 2007;257:23–30. Chabannes 2009 {published data only} Chabannes JP, Bazin N, Leguay D, Nuss P, Peretti CS, Tatu P, et al. Of the interest of the SoleducReg educational program in the prevention of relapses in schizophrenia. Annales Medico-Psychologiques 2009;167:115–8. Cheng 2005 {published data only} Cheng L Y, Chan S. Psychoeducation program for Chinese family carers of members with schizophrenia. Western journal of nursing research 2005;27:583–99. Chien 2013 {published data only} Chien WT, Chan SWC. One-year follow-up of a multiplefamily-group intervention for Chinese families of patients with schizophrenia. Psychiatric Services (Washington, D.C.) 2004;55:1276–84. Chien WT, Chan SWC, Thompson D R. Effects of a mutual support group for families of Chinese people with schizophrenia: 18-month follow-up. British Journal of Psychiatry 2006;189:41–9. Chien WT, Lee IY. The mindfulness-based psychoeducation program for Chinese patients with schizophrenia. PsychiatrIc ServIces 2013;64(4):376–9. Chien WT, Leung SF. A controlled trial of a needs-based, nurse-led psychoeducation programme for Chinese patients with first-onset mental disorders: 6 month follow up. International Journal of Nursing Practice 2013;18:3–13. Fries 2003 {published data only} Fries A, Pfammatter M, Andres K, Brenner HD. Outcome and process characteristics of a psychoeducational, coping oriented group therapy for schizophrenia and schizoaffective patients. Verhaltenstherapie 2003;13(4):237–43. Hamann 2006 {published data only} Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S, et al. Shared decision making for in-patients with schizophrenia. Acta Psychiatrica Scandinavica 2006;114: 265–73. Magliano 2004 {published data only} Magliano L, Fiorillo A, Malangone C, Rosa CDe, Avino C, Amato AG, et al. Effectiveness of a psychoeducational family intervention on social functioning of patients with schizophrenia. (Conference proceedings). 2004. McFarlane 1995 {published data only} McFarlane WR, Link B, Dushay R, Marchal J, Crilly J. Psychoeducational multiple family groups: four-year relapse outcome in schizophrenia. Family process 1995;34:127–44. O’Callaghan 2009 {published data only} O’Callaghan E. Psychoeducation for carers of bipolar and schizophrenia patients. Stanley Foundation Research Programs 2009.

Pfammatter 1999 {published data only} Pfammatter M, Andres K, Brenner HD. Evaluation of psychoeducative and coping-oriented group therapy for patients with schizophrenic and schizoaffective disorders: a multi centre study. Schizophrenia Research 1999;36:331. Pitschel-Walz 2013 {published data only} Pitschel-Walz G, Gsottschneider A, Frobose T, Kraemer S, Bauml J, Jahn T. Neuropsychology of psychoeducation in schizophrenia: Results of the Munich COGPIP study. Der Nervenarzt 2013;84:79–90. Posner 1992 {published data only} Posner CM, Wilson KG, Kral MJ, Lander S. Family psychoeducational support groups in schizophrenia. American Journal of Orthopsychiatry 1992;62:206–18. Ran 2003 {published data only} Ran M. Community mental health in China : a randomized controlled trial of psychoeducational family intervention for carers of persons with schizophrenia in a rural area in Chengdu. Community mental health in China : a randomized controlled trial of psychoeducational family intervention for carers of persons with schizophrenia in a rural area in Chengdu [thesis] 2002. Ran M, Xiang M, Huang M. A control study of psychoeducational family intervention for relatives of schizophrenics in a Chinese rural community. Chinese Journal of Psychiatry 2001;34:98–101. ∗ Ran MS, Xiang MZ, Chan CL, Leff J, Simpson P, Huang M S, et al. Effectiveness of psychoeducational intervention for rural Chinese families experiencing schizophrenia. A randomised controlled trial. Social Psychiatry and Psychiatric Epidemiology 2003;38:69–75. Rotondi 2005 {published data only} Rotondi AJ, Haas GL, Anderson CM, Newhill CE, Spring MB, Ganguli R, et al. A clinical trial to test the feasibility of a telehealth psychoeducational intervention for persons with schizophrenia and their families: intervention and 3month findings. Rehabilitation Psychology 2005;50:325–36. Schlosser 2012 {published data only} Schlosser DA, Miklowitz DJ, O’Brien MP, De Silva SD, Zinberg JL, Cannon TD. A randomized trial of family focused treatment for adolescents and young adults at risk for psychosis: Study rationale, design and methods. Early Intervention in Psychiatry 2012;6(3):283–91. Shin 2002 {published data only} Shin SK, Lukens EP. Effects of psychoeducation for Korean Americans with chronic mental illness. Psychiatric Services (Washington, D.C.) 2002;53:1125–31. Sibitz 2007 {published data only} Sibitz I, Amering M, Gossler R, Unger A, Katschnig H. One-year outcome of low-intensity booster sessions versus care as usual in psychosis patients after a short-term psychoeducational intervention. European Psychiatry 2007; 22:203–10.

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Xiang 1994 {published data only} Xiang M, Ran M, Li S. A controlled evaluation of psychoeducational family intervention in a rural Chinese community. British Journal of Psychiatry 1994;165:544–8. Ying 2006 {published data only} Ying Z P, Wu DC. A control study psychoeducational family intervention for relatives of schizophrenics in a Chinese rural community. Chinese Journal of Primary Medicine Pharmacy 2006;13:819–20.

References to studies awaiting assessment Bechdolf 2000 {published data only} Bechdolf A, Knost B, Pukrop R, Hambrecht M, Klosterkotter J. Coping strategy orientated therapy versus psychoeducational group therapy of post acute patients with schizophrenia or schizoaffective disorders: initial results of a randomised study. Der Nervenarzt 2000;71:379. Cormier 1995 {published data only} Cormier H, Leblanc G, Picher F, Lachance L. Results of a clinical trial of the symptom and medication modules in schizophrenia. Schizophrenia Research 1995;15:146. Eguiluz 1998 {published data only} Eguiluz I, Gonzalez-Torres MA, Munoz P, Guadilla M, Gonzalez G. Evaluation of the efficacy of psychoeducative groups in schizophrenic patients. Actas Luso-Espanolas de Neurologia, Psiquiatria y Ciencias Afines 1998;26:29–34. Hahlweg 1997 {published data only} Hahlweg K. Psychoeducative family care in schizophrenia. conference proceedings. Lengerich, Germany: Pabst, 1997: 56–72. Hornung 1998a {published data only} Hornung WP, Schonauer K, Feldmann R, Monking HS. Medication related attitudes of chronic schizophrenic patients. A follow up study after psycho educational intervention. Psychiatrische Praxis 1998;25(1):25–8. Kissling 2007 {published data only} Kissling W. How can rehospitalisations of patients with schizophrenia be avoided? A comparison between different compliance programs. http://www.controlled-trials.com 2007. Lacruz 1999 {published data only} Lacruz M, Masanet MJ, Bellver F, Asencio A, Ruiz I, Iborra M, et al. Changes in the knowledge of the key relatives about schizophrenia after a psychoeducational family intervention. Archivos de Neurobiologia 1999;62:49–64. Mihai 2005 {published data only} Mihai A, Nirestean A. Psychoeducation improve patient compliance to psychiatric treatment. (conference abstract only). 2005. Motlova 2002 {published data only} Motlova L, Dragomirecka E, Spaniel F, Selepova P. Family psychoeducation in schizophrenia and quality of life in patients and their relatives. Psychiatrie (Stuttgart, Germany). 2002:46–9.

Nischk 2011 {published data only} Nischk D, Gasser M, Polaine K, Rusch J, Schonauer K, Rockstroh B. Effects of a brief psychoeducative intervention for acute psychotic patients. Zeitschrift fur klinische Psychologie und Psychotherapie 2011;40:1616–3443. Pitschel-Walz 1993 {published data only} Bauml J, Kissling W, Buttner P, Schlag K, Pitschel Walz G, Borner R, et al. Psychoeducational groups for schizophrenic patients and their relatives: influence on compliance, rate of rehospitalization and social functioning (PIP-study, Munchen). Pharmacopsychiatry 1993;26:140. Pitschel-Walz G, Boerner R, Mayer C, Engel R, Peuker I, Welschehold M, et al. Psychoeducational groups for schizophrenic patients and their relatives: influence on knowledge, attitudes and familial expressed emotions. Pharmacopsychiatry 1993;26:186. Pitschel-Walz 1997 {published data only} Pitschel-Walz G, Engel R R. Psychoeducation in the treatment of schizophrenia. Psycho 1997;23:22–36. Poplawska 2004 {published data only} Poplawska R, Czernikiewicz A, Szulc A, Galinska B, Konarzewska B, Rudnik-Szalaj I. The effectiveness of psychoeducation in schizophrenic and depressive patients-preliminary report. Psychiatria Polska 2004;38:433–42. Schonell 1995 {published data only} Schonell H, Kumpf S, Gralle J, Gebhardt R. Efficacy of psychoeducational training for schizophrenic and schizoaffective disorders. Pharmacopsychiatry 1995;28:213. Spencer 1988 {published data only} Glick ID, Clarkin JF, Haas GL, Spencer JH. Clinical significance of inpatient family intervention: conclusions from a clinical trial. Hospital & Community Psychiatry 1993; 44:869–73. Spencer JH Jr, Glick ID, Haas GL, Clarkin JF, Lewis AB, Peyser J, et al. A randomized clinical trial of inpatient family intervention, III: effects at 6-month and 18-month followups. American Journal of Psychiatry 1988;145:1115–21. Tarrier 2000 {published data only} Tarrier N. A family support and psychoeducation service for schizophrenia: effectiveness and training. National Research Register 2000. Wirshing 2000 {published data only} Wirshing D, Rossoto E, Wirshing WC, Gonzalez L. The community re-entry program for schizophrenia: preliminary findings. Conference proceedings. 2000. Wirshing 2002 {published data only} Wirshing DA, Wirshing WC, Rossoto E, Gonzalez L, Watson J, Ballon J, et al. The community re-entry program for schizophrenia: correlates of treatment response. Conference proceedings. 2002.

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Amador 1994 Amador XF, Endicott J, Flaum MM, Strauss DH. Validity of the scale to assess unawareness of mental disorder: reply. American Journal of Psychiatry 1994;151(12):1843.

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Elbourne 2002 Elbourne D, Altman DG, Higgins JPT, Curtina F, Worthingtond HV, Vaile A. Meta-analyses involving crossover trials: methodological issues. International Journal of Epidemiology 2002;31(1):140–9.

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Harvey 2013 Harvey C, O’Hanlon B. Family psycho-education for people with schizophrenia and other psychotic disorders and their families. Australian and New Zealand Journal of Psychiatry 2013;47(6):516–20. [PUBMED: 23393269] Herz 2000 Herz MI, Lamberti JS, Minz J, Scott R, O’Dell SP, McCartan L, et al. A program for relapse prevention in schizophrenia: a controlled study. Archives of General Psychiatry 2000;57(3):277–83. Higgins 2003 Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327: 557–60. Higgins 2011 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 [updated September 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.. Hutton 2009 Hutton JL. Number needed to treat and number needed to harm are not the best way to report and assess the results of randomised clinical trials. British Journal of Haematology 2009;146(1):27–30. Kay 1986 Kay SR, Opler LA, Fiszbein A. Positive and Negative Syndrome Scale (PANSS) Manual. North Tonawanda, NY: Multi-Health Systems, 1986. Kemp 1998 Kemp R, Kirov G, Everitt B, Hayward P, David A. Randomised controlled trial of compliance therapy. 18month follow-up. British Journal of Psychiatry 1998;172(5): 413–9. Larsen 1979 Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Evaluation and Program Planning 1979; Vol. 2, issue 3:197–207. Leucht 2005 Leucht S, Kane JM, Kissling W, Hamann J, Etschel E, Engel RR. What does the PANSS mean?. Schizophrenia Research 2005;79(2-3):231–8. [PUBMED: 15982856] Leucht 2005a Leucht S, Kane JM, Kissling W, Hamann J, Etschel E, Engel R. Clinical implications of brief psychiatric rating scale scores. British Journal of Psychiatry 2005;187:366–71. [PUBMED: 16199797] Macpherson 1996 Macpherson R, Jerrom B, Hughes A. A controlled study of education about drug treatment in schizophrenia. British Journal of Psychiatry 1996;168:709–17. Marshall 2000 Marshall M, Lockwood A, Bradley C, Adams C, Joy C, Fenton M. Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for

schizophrenia. British Journal of Psychiatry 2000;176: 249–52. McCormack 2013 McCormack M, Tierney K, Brennan D, Lawlor E, Clarke M. Lack of Insight in Psychosis: Theoretical Concepts and Clinical Aspects. Behavioural and Cognitive Psychotherapy 2013;12:1–12. [PUBMED: 23578588] McCreadie 1987 McCreadie RG, Affleck JW, McKenzie Y, Robinson AD. A comparison of scales for assessing rehabilitation patients. British Journal of Psychiatry 1987;151:520–2. [PUBMED: 3447668] McEvoy 1989 McEvoy JP, Apperson LJ, Appelbaum PS, Ortlip P, Brecosky J, Hammill K, et al. Insight in schizophrenia. Its relationship to acute psychopathology. Journal of Nervous and Mental Disease 1989;177(1):43–7. [PUBMED: 2562850] Montgomery 1979 Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. British Journal of Psychiatry 1979;134(4):382–9. National Institute of Mental Health 1987 National Institute of Mental Health. Towards a Model for Comprehensive Community-Based Mental Health System. Washington, DC: NIMH 1987. Nguyen 1983 Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Evaluation and Program Planning 1983;6(3-4):299–313. [PUBMED: 10267258] Overall 1962 Overall JE, Gorham DR. The brief psychiatric rating scale. Psychological Reports 1962;10:799–812. Pai 1981 Pai S, Kapur RL. The burden on the family of a psychiatric patient: development of an interview schedule. British Journal of Psychiatry 1981;138:332–5. [PUBMED: 7272637] QOF 2009 NICE. Quality and outcomes framework (QOF) indicator development programme. http://www.nice.org.uk/ nicemedia/live/13088/50094/50094.pdf 2009:1–13. Ramirez 2008 Ramirez SZ, Lukenbill J. Psychometric properties of the zung self-rating anxiety scale for adults with intellectual disabilities (SAS-ID). Journal of Developmental and Physical Disabilities 2008;20(6):573–80. Rankin 1996 Rankin SH, Stallings KD. Patient Education: Issues, Principles, Practices. Philadelphia: Lippincott-Raven, 1996. Razali 1997 Razali SM, Yahua H. Health education and drug counselling for schizophrenia. International Medical Journal 1997;4(3): 187–9.

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Rosenberg 1965 Rosenberg M. Society and the Adolescent Self-Image. Princeton, NJ: Princeton University Press, 1965. Ruggeri 1993 Ruggeri M, Dall’Agnola R. The development and use of the Verona expectations for care scale (VECS) and the Verona service satisfaction scale (VSSS) for measuring expectations and satisfaction with community-based psychiatric services in patients, relatives and professionals. Psychological Medicine 1993;23(2):511–23. Ruggeri 1994 Ruggeri M, Dall’Agnola R, Agostini C, Bisoffi G. Acceptability, sensitivity and content validity of VECS and VSSS in measuring expectations and satisfaction in psychiatric patients and their relatives. Social Psychiatry and Psychiatric Epidemiology 1994;29:265–76. Ruggeri 1996 Ruggeri M. Verona Service Satisfaction Scale (VSSS-54) Manual. Verona: WHO Collaborating Centre, 1996. Ruggeri 2000 Ruggeri M, Leese M, Thornicroft G, Bisoffi G, Tansella M. Definition and prevalence of severe and persistent mental illness. British Journal of Psychiatry 2000;177:149–55. Rummel-Kluge 2008 Rummel-Kluge C, Kissling W. Psychoeducation in schizophrenia: New developments and approaches in the field. Current Opinion in Psychiatry 2008;21(2):168–72. Schinnar 1990 Schinnar AP, Rothbard AB, Kanter R, Jung YS. An empirical literature review of definitions of severe and persistent mental illness. American Journal of Psychiatry 1990;147(12): 1602–8. Schünemann 2008 Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ, Glasziou P, et al. Chapter 12: Interpreting results and drawing conclusions. In: Higgins JPT, Green S editor(s).

Cochrane Handbook for Systematic Reviews of Interventions. The Cochrane Collaboration, 2008:359–83. Taylor 2003 Taylor JE, Poston WS 2nd, Haddock CK, Blackburn GL, Heber D, Heymsfield SB, et al. Psychometric characteristics of the general well-being schedule (GWB) with AfricanAmerican women. Quality of Life Research 2003;12(1): 31–9. [PUBMED: 12625516] Tu 1997 Tu LJ, Zhu L, Xu GB. Nursing study of social disability in schizophrenics. Chinese Journal of Nursing 1997;32(8): 440–2. [PUBMED: 9495959] Ukoumunne 1999 Ukoumunne OC, Gulliford MC, Chinn S, Sterne JAC, Burney PGJ. Methods for evaluating area-wide and organistation-based intervention in health and health care: a systematic review. Health Technology Assessment 1999;3(5): 1–75. Wang 1999 Wang XD. The Handbook of Assessment of Mental Health. Changsha: Chinese Journal of Mental Health, 1999. Wu 2006 Wu T, Li Y, Liu G, Bian Z, Li J, Zhang J, et al. Investigation of authenticity of ’claimed’ randomized controlled trials (RCTs) and quality assessment of RCT reports published in China. Proceedings of the 14th Cochrane Colloquium; 2006 October 23-26; Dublin. 2006. Xia 2009 Xia J, Adams CE, Bhagat N, Bhagat V, Bhoopathi P, ElSayeh H, et al. Loss to outcomes stakeholder survey: the LOSS study. Psychiatric Bulletin 2009;33(7):254–7. Xia 2011 Xia J, Merinder LB, Belgamwar MR. Psychoeducation for schizophrenia. Cochrane Database of Systematic Reviews 2011, Issue 6. [DOI: 10.1002/14651858.CD002831.pub2; PUBMED: 21678337] ∗ Indicates the major publication for the study

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID] Both - Liu 2004 Methods

Allocation: randomised - no further description. Blindness: not stated. Duration: 6 months. Setting: JiNing Psychiatric Prevention Hospital, China.

Participants

Diagnosis: schizophrenia (CCMD-3). n = 118. Age: average age ~ 41years (SD ~ 9). Sex: male and female. History: average length of illness ~ 14.5 years (SD ~ 9). Inclusion: living in JiNing city district with relative; stabilised condition, BPRS score < 30. Exclusion: patients with heart, liver, renal impairment, drug or alcohol dependency

Interventions

1. Family intervention + routine rehabilitation therapy: 60-90 minutes/month, for 6 months in the form of outpatient home visit: familiarise patients with basic knowledge of schizophrenia; provide patients with individualised guidance on communication skills, common drug adverse events and coping strategies, as well as how to recognise early warning signs of relapse; answer family members’ enquiries regarding patients behaviour and social functioning; organise seminars for patients and family to exchange experience (two seminars in total run at 2-3 hours each), n = 59 2. Routine rehabilitation therapy, n = 59.

Outcomes

Mental state: GWB, SES. Social functioning: MRSS, SDSS. Unable to use Knowledge: increase (unpublished scale). Compliance: (unpublished scale).

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

Randomised, but no detail described.

Allocation concealment (selection bias)

Not described.

Unclear risk

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Not stated.

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Both - Liu 2004

(Continued)

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

Low risk

No incomplete outcome data.

Selective reporting (reporting bias)

Low risk

All measured outcomes were reported.

Other bias

Unclear risk

None obvious.

Both - Tom 1989 Methods

Allocation: randomised. Blinding: not stated. Duration: 5 weeks. Setting: outpatient mental health service, New York city’s Chinatown

Participants

Diagnosis: schizophrenia (DSM-III). n = 30. Age: treatment group - mean 34.08 years, range 18-56 years; control group - mean 36. 67 years, range 26-60 years Sex: M 19, 5 F. History: (length of illness) treatment group - mean 11.25 years, range 1-29 years; control group - mean 16 years , range 1-35 years Included: Chinese speaking Excluded: not stated.

Interventions

1. Continuing treatment program + psychoeducation: content included: continuing treatment program, psychotherapy, occupational and recreational therapy with a specialised cultural orientation, skills of daily living, English language class, arts and crafts, cultural activities,etc; psychoeducation, group presentation (lecture with a slide show) ; individual sessions with a interview schedule, eight group sessions and one individual session over 5 weeks, n = 15 2. Continuing treatment program: psychotherapy; occupational and recreational therapy with a specialised cultural orientation, skills of daily living, English language class, arts and crafts, cultural activities; scheduled daily, n = 15

Outcomes

Compliance - leaving the study early; lost to follow-up Knowledge of mental illness and treatment- KSQ Satisfaction with services- CSQ-8 Unable to use Motivation for treatment - TCL (instrument non-validated) Attitude toward mental illness- OMI (instrument non-validated)

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Both - Tom 1989

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Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Low risk bias)

Randomised: the first name drawn and assigned to either Interveniton group or control group

Allocation concealment (selection bias)

Unclear risk

Not reported.

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not reported.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not reported.

Incomplete outcome data (attrition bias) All outcomes

High risk

Leaving the study early: Intervention group: n =- 3 excluded as did not attend the sufficient sessions; Control group: n = 3 for failure to attend or complete the program. No ITT analysis

Selective reporting (reporting bias)

High risk

No means or SDs reported for all outcomes scales - only data for attrition were usable in data and analysis

Other bias

Unclear risk

No further info.

Both - Zhang 2004 Methods

Allocation: randomised - no further description. Blindness: not stated. Duration: 4 weeks. Setting: JiNing Psychiatric Prevention Hospital, ShangDong, China

Participants

Diagnosis: schizophrenia (CCMD-3). n = 146. Age: average age ~ 37 years (SD ~ 11). Sex: male and female. History: length of illness 3 months - 10 years. Inclusion: patients with stabilised psychotic symptoms after systematic anti-psychotic medication, and most cognitive functioning have recovered; without medication side effects; can independently complete questionnaire. Exclusion: patients with either self- or drug-induced depression or anxiety

Interventions

1. Health belief model: this is delivered in the form of both group and individual therapy - i. analyse cause & nature of illness with patients; ii. guide patients to associate recovery with health education; encourage patients to participate in sports, entertainment activi-

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ties and travel; help patients to develop hobbies; communicate their feelings with nurses or family, friends; 30 minutes/time, 2 times/week for 4 weeks. n = 74 2. Routine health education. n = 72. Outcomes

Social functioning: SAS; SDS, anxiety and depression incidence rate*

Notes

*SAS score > 51 is considered as having anxiety; SDS score > 51 is considered as having depression

Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

Randomised, no further description.

Allocation concealment (selection bias)

Not described.

Unclear risk

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not stated.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

Low risk

No incomplete outcome data.

Selective reporting (reporting bias)

Low risk

All measured outcomes were reported

Other bias

Low risk

None obvious.

Group - Aguglia 2007 Methods

Allocation: randomised. Blindness: Single, only participants were blinded. Duration: 12 months. Setting: 15 Community Mental Health Centres in Italy.

Participants

Diagnosis: Schizophrenia. n = 150. Age: 18 - 45. Sex: 35 F, 100 M, (Control: 21 F, 45 M and Experimental: 14 F, 55 M) History: undergoing standardised drug therapy. Included: diagnosed with schizophrenia in agreement with DSM IV and ICD. Exclusion: acute psychosis, substance abuse problems, organic factors that could interfere with clinical condition, patients currently participating in psychoeducational and

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structured interventions or participated in the last 2 years (p4) Interventions

1. Traditional psychosocial interventions, anti-psychotic drug treatment, 8 different parallel sessions of psychoeducational program 60-90 minutes each (n = 69) 2. Standard procedure: anti-psychotic drug treatment (dosage monitored every 6 months) and assertive community treatment (n = 66) Antipsychotic drug management: traditional and atypical antipsychotic drugs, administered alone or combined; also receive some “long acting” (haloperidol decanoate, fluphenazine decanoate, zuclopenthixol decanoate) antipsychotic drugs

Outcomes

Compliance: Leaving the study early. Service utilisation: Number of hospitalisations. Unable to use Adherene: Rating of Medication Influences (ROMI): No means reported Mental state: BPRS, SAPS, SANS: no means reported. Social functioning: SAS - no means reported. QOL: Lancashire Quality of life scale: no means reported.

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

No description of random allocation provided.

Allocation concealment (selection bias)

No information provided on allocation concealment.

Unclear risk

Blinding of participants and personnel High risk (performance bias) All outcomes

Study participants were blind to randomisation. Quote: “The patients were blindly randomised by the experimenter into two groups”. The authors have recommended a double-blind study. Quote: “Though the staff carrying out psychoeducation and standard psychosocial intervention and the staff administering the scales were different, the open label design of the study could bring some biases. A double blind study should be recommended”

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Although the study is an open-label design, the staff carrying out psychoeducation intervention and the staff administering the scales were different

Incomplete outcome data (attrition bias) All outcomes

No specific reasons given for dropouts (n = 15). Quote: “135 patients finished the

High risk

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study; 15 dropped out for different reasons unrelated to the study”. No mention of how attrition was addressed in the analysis. Quote: “The percentage of the participants hospitalised between 1 and 3 times during the 12 months resulted to be 13% after 6 months, and 3,3% after a year with a difference of 9.7% for the study group; while for the control group the variation went from 17.7% at 6 months to 10.5% after 1 year with an improvement of 7,2%” Selective reporting (reporting bias)

Unclear risk

Most outcomes are reported but no clarity on number of participants used in the analysis

Other bias

Unclear risk

Funding: not stated.

Group - Bauml 2007 Methods

Allocation: random. Blindness: blind to randomisation. Duration: 4 to 5 months, follow-up 12 and 24 months. Setting: multi-centre study, three psychiatric hospitals in Munich, Germany (1990-1994)

Participants

Diagnosis: schizophrenia or schizophrenia disorder (DSM-III-R/ ICD-9) n = 236. Age: mean 34 ± 10.9 years. Sex: M 109, F 127. History: length of Illness mean 6.6 ± 6.0 years. Included: schizophrenia DSM-III-R; indication for an antipsychotic relapse prevention for a period of at least 12 months; age 18 and 65 years; patients’ agreement to undergo outpatient treatment at the study centre; patients’ agreement to invite a key relative or a friend Excluded: living at a distance of more than 150 kilometres from the hospital; less than 30 minutes’ contact per week with the key relative; drug addictions during the past 6 months prior to admission; pregnancy; IQ < 80; insufficient knowledge of German; lack of remission of the psychotic symptoms during the previous 2 years despite an adequate therapy

Interventions

1. Psychoeducational group: delivered by separate therapists to patients and relatives; included emotional relief; take-home message; group discussion about coping strategies; information booklet; also received routine care. For patients: 60 min/session, 4 weekly sessions + 90-120min/session, 4 monthly. For relatives: 90-120 min/session, 8 biweekly sessions, n = 125 2. Routine care: outpatient treatment for all patients: Treatment as usual medication management, n = 111

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Outcomes

Compliance:Leaving the study early. Unable to use Mental state:BPRS Global State: GAS (no means or SDs reported). Rehospitalisation rates; days in hospital (not reported by group)

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Low risk bias)

Group randomisation was done centrally; the groups were formed independently in each study centre

Allocation concealment (selection bias)

Randomisation was done centrally.

Low risk

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not reported.

Blinding of outcome assessment (detection High risk bias) All outcomes

Therapist not blinded.

Incomplete outcome data (attrition bias) All outcomes

High risk

Dropout: 19 patients excluded for formal reasons or due to premature discontinuation of the intervention, no ITT analysis

Selective reporting (reporting bias)

Low risk

All the outcome measures were reported.

Other bias

Unclear risk

Funding: German Ministry of Research and Technology (0701854 = 819754-3). The first 2 years of the Psychosis Information (PIP) Study were supported by a grant from the German Ministry of Science and Research (BMFT). The long-term followup of the sub-sample from the TechnicalUniversity of Munich was supported by a grant from the DORIST-Fondin Kreuzlingen, Switzerland

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Group - Bechdolf 2004 Methods

Allocation: randomised. Blinding: rater-blind. Duration: 8 weeks delivery; 6- and 24-month follow-up. Setting: acute inpatient admissions, Department of Psychiatry and Psychotherapy, University of Cologne (Germany) (July 1999 and December 2000)

Participants

Diagnosis: acute schizophrenia or related disorder (ICD-10). n = 88. Age: PE - mean 31.4 ± 10.6 years; CBT - mean 32.2 ± 9.9 years Sex: PE - M 22, F 26; CBT M 18; F 22. History: PE - mean length of illness 50±58.7 months; CBT - mean length of illness 56. 7±65.4 months Included: age 18-64 years; episode of a schizophrenic or related disorder (ICD-10) Excluded: drug or alcohol dependence; organic brain disease; learning disability; hearing impairment; non-German speakers

Interventions

1. Group psychoeducational programme (PE)*: symptoms of psychosis; models of psychosis; effects and side effects of medication; maintenance medication;early symptoms of relapse; relapse prevention; 60 - 90 min/time, one time/week for 8 weeks, maximum 8 sessions, n = 48 2. Group cognitive behavioural therapy (CBT)*: delivered by an experienced and CBT trained psychiatrist or clinical psychologist; treatment of auditory hallucinations and delusions, associated symptoms and problems; relapse prevention and associated problems and enhancing medication compliance; 60 - 90 min/time, 2 sessions/week for 8 weeks, maximum 16 sessions, n = 40

Outcomes

Compliance scale (4-point scale, used in other studies, rated by patient, relatives, psychiatric nurse and psychiatrist in charge) at pre-, post-treatment and 24-month followup Relapse rate (defined as: rating of at least 5 and a 2-point increase compared with the previous assessment in at least one of the items of the positive syndrome sub scale of PANSS) at 6 months Mental state: PANSS at pre-, post treatment, 6 months after treatment and 24-month follow-up Medication use at pre, post treatment, 6 months after treatment and 24-month followup Quality of Life : Seven areas of MSQoL scores at pre, post, 6-month follow up Rehospitalisation rates at 6-month and 24-month follow-up.

Notes

*Both interventions adjunct to routine hospital care; participants remained under medical supervision of the responsible consultant psychiatrist who alone determined the pharmacological regime, timing of discharge and readmission

Risk of bias Bias

Authors’ judgement

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Support for judgement

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Random sequence generation (selection Low risk bias)

Random: quote “...by computer-generated random numbers for blocks of eight participants, the results were placed in sealed envelopes and only opened at the time of treatment” (p22). Blind assessments by carrying out most of the assessments by independent raters

Allocation concealment (selection bias)

Placed in sealed envelopes and only opened at the time of treatment allocation

Low risk

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Quote, “with regard to psychopathology and compliance measures, we made attempts to blind assessments by carrying out most of the assessments by independent raters who were not involved in the treatment” (p22)

Blinding of outcome assessment (detection Low risk bias) All outcomes

Blind assessments by carrying out most of the assessments by independent raters

Incomplete outcome data (attrition bias) All outcomes

High risk

n = 17 participants lost to follow-up.

Selective reporting (reporting bias)

High risk

MSQoL not reported, will be reported elsewhere. Continuous scores for PANSS and compliance differ between published reports at 6 months and 24 months. Results from the 24-month report show significant difference in results - data from the first published report were used for short-term and medium-term outcomes

Other bias

Low risk

This work was supported by grant from the Koln For-tune Program (191/1998) Faculty of Medicine, University of Cologne, Germany

Group - Chan 2007 Methods

Allocation: randomised - no further description. Blinding: not stated. Duration: 2 weeks + 12 months follow-up. Setting: Pamela Youde Nethersole Eastern Hospital, Hongkong, China

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Participants

Diagnosis: schizophrenia (DSM-IV). n = 81. Age: 18-65 years. Sex: male and female. History: not stated. Exclusion: not stated.

Interventions

1. Psychoeducation: didactic presentation on mental health, schizophrenia, rehabilitation resources, medication management & compliance, relapse prevention & stress management; 50 minutes/session, 10 sessions. n = 44 2. Routine care. n = 37.

Outcomes

Relapse. Knowledge: Insight-SAUMD scores. Unable to use Quality of life: SF-36 (sub-scores only).

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

Randomisation method not stated.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not stated.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

Low risk

No incomplete data.

Selective reporting (reporting bias)

Low risk

All measured outcomes reported.

Other bias

Low risk

None obvious.

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Group - Chan 2009 Methods

Allocation: randomised. Blinding: not stated. Duration: 3 months treatment + 12 months follow-up. Setting: psychiatric outpatient department of a regional mental hospital, Hong Kong

Participants

Diagnosis: schizophrenia (DSM-IV). n = 73. Age: 18-65 years (mean age 35.3±11.6). Sex: male (n = 48) and female (n = 25). History: not stated. Inclusion: clients had been diagnosed with schizophrenia by their attending psychiatrist and according to DSM IV within the previous 24 months, between the ages of 18 - 65, they were Hong Kong Chinese residents living with their families after discharge, were able to speak Cantonese, were will to participate in the study with their family caregivers + caregivers had to care for the client for at least 4 hours per day, live with the client, aged 18 or over, free from any mental disorders, be able to speak Cantonese, both client and caregiver had to agree to take part in the study together. Exclusion: clients with secondary diagnosis of a mental or physical disorder; caregivers were excluded if they were also currently providing care for another family member with a chronic physical or mental illness

Interventions

1. Psychoeducation + routine care: providing information on cause, development & treatment of schizophrenia, its recovery, relapse & early warning signs; 10 sessions over 3 months, n = 36 2. Routine care, n = 37.

Outcomes

Mental state: BPRS endpoint scale score (data skewed). Knowledge: ITAQ endpoint scale score. Unable to use Satisfaction: continuous satisfaction data - unclear from which scale they are derived from. Quality of life: FBIS endpoint scale score, no N number reported, data are skewed

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Low risk bias)

Random assignment generated by drawing lots. Quote: “After their written consent was obtained, the participants were randomly assigned to experimental and control groups by drawing lots”

Allocation concealment (selection bias)

Not stated.

Unclear risk

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Blinding of participants and personnel Unclear risk (performance bias) All outcomes

No clear description of blinding of participants or raters. Quote: “All the pre- and post-tests were conducted by an assigned mental health nurse who was not involved in the intervention to avoid bias”. Not clear from this quote whether the mental health nurse was blind to intervention

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

Low risk

No dropouts and no cases excluded.

Selective reporting (reporting bias)

High risk

Some scale data (SSQ-6, SES) were not reported.

Other bias

Low risk

None obvious.

Group - Coyle 1988 Methods

Allocation: randomised. Blindness: none reported. Duration: 6 months (10 sessions + 1 introductory and termination session used for data collection) Setting: outpatient mental health clinic, Jamaica.

Participants

Diagnosis: schizophrenia. n = 94 (14 dropping out + incomplete data collection on 2 individuals). Age: 18-80 (mean age: 46.6, age range 21 to 72). Sex: M 40, F 38 . History: had been hospitalised before. Included: unemployed clients with a low income status, on psychotropic medication, primary diagnosis of schizophrenia and lived with at least one family member Exclusion: clients with a diagnosis of drug and/or alcohol abuse

Interventions

1. Psychoeducational + Psychotropic medication: educating individuals about the nature, aetiology and management of schizophrenia, n = 17 2. Psychotropic medication only: monthly brief (15 minutes or less) evaluation by the treating psychiatrist, n = 21 [3. Social skills training + Psychotropic medication: group therapy training individuals in social, coping and basic living skills and behaviours (n = 19). 4. Individual supportive therapeutic method + Psychotropic medication: supporting the individual by using problemsolving skills through techniques of verbal reinforcement and encouragement (n = 21).] - these groups not included in analysis.

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Group - Coyle 1988

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Outcomes

Leaving study early . Hospitalisation. Unable to use Behaviour: KAS: unable to use as only means reported and no SD reported

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Low risk bias)

Stratified random assignment: stratified according to age, sex, race. Then a stratified random assignment was performed ensuring there were equal numbers of participants in sub categories

Allocation concealment (selection bias)

No allocation concealment from those delivering the intervention as all 3 workers delivering the intervention delivered all 3 interventions. No other allocation concealments mentioned

Unclear risk

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

None reported.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not reported

Incomplete outcome data (attrition bias) All outcomes

Unclear risk

Dropouts accounted for: In the individual therapy group: n = 1 died of medical causes, n = 1 hospitalised, n = 1 did not complete the data. In the medication use group: n = 1 dropped out, n = 1 hospitalised, n = 1 did not complete the data; In the social skills training group: n = 3 dropped out, n = 1 hospitalised; In the psychoeducational group: n = 4 dropped out, n = 2 hospitalised. ITT analysis was not applied

Selective reporting (reporting bias)

Unclear risk

Only means reported with no SDs.

Other bias

Unclear risk

Funding: source not provided. Interested participants self-selected themselves to be part of the study

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Group - Dai 2007 Methods

Allocation: randomised. Blinding: not stated. Duration: 8 weeks. Setting: Yangzhou Wutaishan Hospital, Jiangsu Province, China

Participants

Diagnosis: schizophrenia (CCMD-3). n = 102. Age: not stated. Sex: not stated. History: not stated. Exclusion: severe physical or other mental illness.

Interventions

1. Psychoeducation + routine drug therapy: provide patients with information on cause, development & symptoms of illness, crisis strategy, communication with family member, maintain medication; 30-60 minutes/week. n = 51 2. Routine drug therapy. n = 51.

Outcomes

Compliance: with medication. --Unable to use Behaviour: NOSIE score, the data and its interpretation are controversial in the original studies

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

Randomisation method not stated.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not stated.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

Low risk

No incomplete outcome data.

Selective reporting (reporting bias)

High risk

PANSS, ITAQ scores measured, but not reported.

Other bias

Low risk

None obvious.

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Group - Hornung 1995 Methods

Allocation: randomised. Blinding: raters were not blind to the treatment conditions except compliance rated by independent raters at 1 year. Duration: 15 weeks and follow-up 5 years. Setting: Germany.

Participants

Diagnosis: schizophrenia (DSM-III-R) with the exception of schizoaffective disorder. n = 191*. Age: mean 31.9 years, SD ~ 7.8 years. Sex: male and female. History: ’chronic’, outpatients, > 2 acute episodes in last 5 years, illness duration mean 8.3 years (SD 5.7), onset of illness mean ~ 24 years, mean ~ 4 (SD 3.1) hospitalisations, BPRS mean ~ 27 (SD 6.4), GAS mean 55 (SD 10.4), daily neuroleptic dose mean ~ 470 mg CPZ (SD 680)

Interventions

1. Psychoeducational medication training (PT) + leisure time group (LTG) at 7 study centres: 10 sessions in groups of 4-6 patients with one or two psychotherapists during 15 weeks. First 5 sessions once a week, next five twice a fortnight. n = 32. 2. PT + key person counselling 10 sessions (KC) + LTG. n = 35. 3. PT + cognitive psychotherapy (CP). n = 34. 4. PT + KC + CP. n = 33. 5. Control group patients attended a structured but unspecific leisure-time group of same length. n = 57

Outcomes

Relapse. Global state: GAS. Unable to use Medication compliance (no usable data). Mental state: BPRS (no usable data). Qualification for medication self-management (no usable data). Illness-related attitudes: KK-Skala (no usable data). Satisfaction with knowledge (no usable data).

Notes

*n = 44 patients dropped out before start of intervention and were not included in the data reporting and analysis of the original study, so we could not make “lost binary data” assumptions

Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Low risk bias)

Randomised by independent third party, in which age, sex, prognosis and medication compliance were balanced by preliminary matching. Randomisation by an independent institution, ZMBT

Allocation concealment (selection bias)

Unclear.

Unclear risk

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Blinding of participants and personnel High risk (performance bias) All outcomes

Blind rating for readmission (independent criterion as researchers had no influence on this). Relapse data, compliance data and other outcomes where not blindly rated

Blinding of outcome assessment (detection High risk bias) All outcomes

Blind rating for readmission (independent criterion as researchers had no influence on this). Relapse data, compliance data and other outcomes where not blindly rated

Incomplete outcome data (attrition bias) All outcomes

High risk

n = 44 patients dropped out before start of intervention and were not included in analysis but compared on socio-demographic and other characteristics to trial group

Selective reporting (reporting bias)

Low risk

All measured outcomes reported.

Other bias

Low risk

None obvious.

Group - Li 2003 Methods

Allocation: randomised - no further description. Blindness: not stated. Duration: 6 months. Setting: ChuXiongZhou Psychiatric Hospital, YunNan Province, China

Participants

Diagnosis: schizophrenia (CCMD-2-R). n = 120. Age: average age ~ 37 (SD ~ 10). Sex: male and female. History: average length of illness ~ 13 years (SD ~ 9). Inclusion: not stated.

Interventions

1. Family intervention (psychoeducation): introduce to patients and family basic information about schizophrenia, its treatment and rehabilitation, adverse effects of medication & importance of continuous treatment; guidance on communication & social skills; 1/month for 6 months. n = 68 2. Routine care. n = 52.

Outcomes

Mental state: BPRS. Unable to use -: Mental state: BPRS sub-scale scores. Behavioural outcome - level of symptoms: SCL-90 sub-scale scores

Notes Risk of bias

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Group - Li 2003

(Continued)

Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

Randomised, but no randomisation detail described.

Allocation concealment (selection bias)

Not described.

Unclear risk

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not stated.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

High risk

Those leaving early were excluded from the analysis

Selective reporting (reporting bias)

Low risk

All measured outcomes were reported.

Other bias

Low risk

None obvious.

Group - Lv 2007 Methods

Allocation: randomised - by tossing a coin. Blinding: not stated. Duration: 8 weeks + 9 months. Setting: inpatient, Jinhua Number 2 Hospital, Zhejiang, China

Participants

Diagnosis: schizophrenia. n = 62. Age: mean ~ 35 years, SD ~ 6 years. Sex: male and female. History: not stated. Exclusion: severe physical illness.

Interventions

1. Psychoeducation: background knowledge on schizophrenia; importance of family environment; role of family members; group therapy, one session/week. n = 30 2. Routine care. n = 30.

Outcomes

Quality of life: FAD, GQOLI-74.

Notes Risk of bias Bias

Authors’ judgement

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Support for judgement

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Random sequence generation (selection Low risk bias)

Randomised by tossing a coin.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not stated.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

Low risk

No incomplete data.

Selective reporting (reporting bias)

Low risk

All measured outcomes reported.

Other bias

Low risk

None obvious.

Group - Merinder 1999 Methods

Allocation: stratified for gender and for illness duration, randomisation carried out by an independent institution. Blinding: relapse and compliance assessed blindly. Duration: 8 weeks, 1 year follow-up. Setting: two community psychiatric centres in Aarhus and Viborg, Denmark

Participants

Diagnosis: schizophrenia (F20.2-F20.9) ICD Danish version, OPCRIT. n = 46. Age: median 35.9 years, interquartile range 30.3 to 39.6 years. Sex: male and female. History: illness duration median 8.2 years, earlier admissions median 5. In treatment at 2 community psychiatric centres

Interventions

1. Psychoeducational sessions: 8 sessions, using didactic, interactive method standardised with manual for group leaders and booklet for participants; weekly group of 5 to 8 participants conducted separately for patients and relatives, n = 24 2. Standard care: psychopharmacological treatment, psychosocial rehabilitation efforts and some supportive psychotherapy, n = 22

Outcomes

Compliance: non-compliance episodes of 14 days. Relapse. Mental state: BPRS. Global state: GAF. Satisfaction: VSSS. Expressed emotion: FQ. Unable to use -

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Knowledge: (instrument non-validated). Insight: IS (instrument non-validated). Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Low risk bias)

Randomisation carried out by an independent institution.

Allocation concealment (selection bias)

Patients included before randomisation, given participant numbers, separated from patient identification data. Allocation of patent-numbers to intervention/control done subsequently.

Low risk

Blinding of participants and personnel Low risk (performance bias) All outcomes

Single blind (assessor blind).

Blinding of outcome assessment (detection Low risk bias) All outcomes

Single blind (assessor blind).

Incomplete outcome data (attrition bias) All outcomes

Low risk

ITT used.

Selective reporting (reporting bias)

Low risk

ITT used.

Other bias

Unclear risk

None obvious.

Group - Razali 1995 Methods

Allocation: random. Blinding: not reported. Duration: one session and follow-up 1 year. Setting: Malaysia.

Participants

Diagnosis: schizophrenic disorder (DSM-III-R). n = 165. Age: < 15 years 6 patients and > 60 years 2 patients, most between 20-30. Sex: M 69, F 96. History: all poor compliance, 46 patients had depot injection, 30% treated with chlorpromazine, haloperidol or trifluoperazine, 30% chronic

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Group - Razali 1995

(Continued)

Interventions

1. Counseling session: by trained hospital pharmacist at discharge in presence of key relative; frequency of drug dosage was reduced to twice a day. n = 85 2. No counselling: also received routine prescription of medication. n = 80

Outcomes

Relapse.

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

Randomisation method not stated.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not stated.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

Unclear risk

Not stated concerning total dropout and ITT (intention-to treat-criteria fulfilled)

Selective reporting (reporting bias)

Low risk

Only compliance and readmission measured and reported.

Other bias

High risk

Control patients were not given as much therapist time.

Group - Zhang 2006 Methods

Allocation: randomised - no further description. Blinding: not stated. Duration: 8 weeks. Setting: Mental Health Centre of Shantou University, Guangdong, China

Participants

Diagnosis: schizophrenia (CCMD-3). n = 60. Age: not stated. Sex: not stated. History: not stated. Exclusion: severe physical or other mental illness, drug/alcohol dependent

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Group - Zhang 2006

(Continued)

Interventions

1. Psychoeducation + standard drug therapy: provide patients with information on cause, development & symptoms of illness, crisis strategy, communication with family member, maintain medication; 30 minutes/session, 1 session/week. n = 30 2. Standard drug therapy. n = 30.

Outcomes

Compliance with medication. Mental state: BPRS score.

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

Randomisation method not stated.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not stated.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

Low risk

No incomplete outcome data.

Selective reporting (reporting bias)

Low risk

All measured outcomes reported.

Other bias

Low risk

None obvious.

Individual - Cunningham 2001 Methods

Allocation: randomised. Blindness: none. Duration: 12 months (intervention: 1, 15-minute session). Setting: 11 Hospitals, Scotland.

Participants

Diagnosis: schizophrenia (DSM-III-R). n = 114. Age: 16 - 64 [mean age: control group, 33.6 (10.8), intervention group 36.8 (10.4)] Sex: M 81 and F 33. History: psychiatric history and current medication information. Included: DSM-III-R diagnosis of schizophrenia, at least one episode of schizophrenia, aged 16-64, due for discharge from inpatient or day patient care, recommendation for

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Individual - Cunningham 2001

(Continued)

maintenance antipsychotic medication from responsible consultant, informal legal status Exclusion: patients on clozapine or lithium. Interventions

1. Education intervention: 15 minute video, 3 booklets containing information from the video, 15-minute educational video and three differently presented booklets about improve understanding of illness and acceptance of medication; enhance factual knowledge and correct erroneous, insight-related misconceptions about the disorder, the risks of relapse, consequences of symptom exacerbation; address the question of stigma, nature and treatment of side effects. n = 61 2. Standard care: routine clinical practice - participants were seen by the research psychiatrist and having the same standardised mental state assessments conducted; treated as in routine clinical practice n = 53

Outcomes

Relapse. Medication side effects: TAKE, AIMS, the Barnes akathisia scale, UKU side effect rating scale Mental state: PANSS, MADRS. Knowledge: ITAQ. Unable to use PANSS: no useable data reported.

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Low risk bias)

Following initial assessment, participants were allocated by means of random numbers in sealed envelopes to either intervention or control group

Allocation concealment (selection bias)

Randomszation was conducted at the trial centre and was remote from the assessors

Low risk

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Patients were followed up by a research psychiatrist who was not blind to group status

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

No reported

Incomplete outcome data (attrition bias) All outcomes

No information given on why participants dropped out. Quote:” Nine patients in the intervention group (14.8%) and nine in the control group (17.0%) dropped out prematurely”. High number of relapse rate in the study. Quote “Over the 12 months of

Unclear risk

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Individual - Cunningham 2001

(Continued)

follow-up, 22 (36.1%) of the intervention group and 22 (41.5%) of the control group relapsed”. Exclusions not clearly reported for some outcome data. Quote: “Such data were only available on the 46 subjects who had neither relapsed nor dropped-out” Selective reporting (reporting bias)

Unclear risk

All outcome data are reported but lack of clarity on some main outcomes, such as PANSS no means or SD reported. Lack of clarity on dropouts and relapse rates at every follow-up stage

Other bias

Low risk

Funding: funded by the Medical Research Council of Great Britain

Individual - Macpherson 1996 Methods

Allocation: random - a random numbers table. Blinding: all ratings were carried out by the author, without blinding procedures. Duration: 7 weeks. Setting: UK.

Participants

Diagnosis: schizophrenia (DSM-III-R). n = 67. Age: mean 45.2 years, SD ~ 13 years. Sex: M 48, F 16. History: largely (54/64) community based, chronic, institutionalised population, at least 6 months cumulative antipsychotic drug exposure and clinical stability. Years in institution mean 12.8 (SD 11.8). Education mean 11 y (SD 1.9).

Interventions

1. Single individualised educational session: followed manual guidelines based on psychoeducation literature & principles of general health education. n = 24 2. Individualised teaching: in 3 education sessions 25-35 minutes/session at weekly interval. n = 23 3. No education. n = 20.

Outcomes

Compliance: SAI - compliance sub-scale. Knowledge change: UMQ. Unable to use Mental state (no usable data).

Notes

All education was performed by the author RM.

Risk of bias Bias

Authors’ judgement

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Individual - Macpherson 1996

(Continued)

Random sequence generation (selection Low risk bias)

Using a random numbers table

Allocation concealment (selection bias)

Not stated.

Unclear risk

Blinding of participants and personnel High risk (performance bias) All outcomes

Open label

Blinding of outcome assessment (detection High risk bias) All outcomes

Open label

Incomplete outcome data (attrition bias) All outcomes

Low risk

No incomplete data.

Selective reporting (reporting bias)

Low risk

All measured outcomes reported.

Other bias

Low risk

None obvious.

Individual - Nasr 2009 Methods

Allocation: randomised. Blindness: researcher blind. Duration: 6 months post intervention (intervention: 9 sessions over 6 months) Setting: outpatient department, Lahore, Pakistan.

Participants

Diagnosis: schizophrenia (DSM-IV TR). n = 108. Age: 18-45 (mean age: control group, 27.00 (7.29), intervention group 25.31 (7.02)) Sex: M 58, F 50. History: age at onset, number of admissions in hospital, number of relapses, family history of mental illness. Included: aged between 18-45 years, history of two or more relapses during the course of their illness despite getting treatment Exclusion: patients manifesting schizophrenia-like symptoms due to any organic disorder such as dementia or any other cognitive impairment, abuse of alcohol or of drugs acting on the central nervous system and those with clinical evidence of epilepsy or intellectual disability

Interventions

1. Psychoeducation + psychotropic drugs; for families and patients - content: general information about schizophrenia, its nature, types and causes; schizophrenia affecting on thoughts, emotions and behaviour; importance of pharmacological treatment; general advice encouraging family members to address their personal and social needs; following five sessions were discussion about the problems,when the patient was in a stable phase, they will be educated on the nature and process of illness and compliance with pharmacological treatment, n = 52 2. Psychotropic drugs, n = 56.

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Individual - Nasr 2009

(Continued)

Outcomes

Relapse. Death. Unable to use Number of relapses: no data scores mentioned Family burden (FBIS): skewed data

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Low risk bias)

Random allocation done independently. Quote: “Patients with schizophrenia were randomly allocated to one of two groups, a psychoeducation group or a non-psychoeducation group” (p5)

Allocation concealment (selection bias)

An independent controlled randomly allocated the individuals to either the psychoeducation or control group. Quote: “The researcher was not involved in the randomisation of the patients and families, which was performed at the institution.”

Low risk

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

No blinding information given on patients and families, the researcher was not involved in randomisation but no clear information whether they were blinded

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

As above.

Incomplete outcome data (attrition bias) All outcomes

High risk

n = 8 individuals were lost at follow-up. Only addressed: one died (psycho-education group). No mention of the n = 7 that were dropped/lost at the follow-up stage and from which group. No mention of whether they were excluded from the analysis

Selective reporting (reporting bias)

Unclear risk

Number of relapses was collected but not reported in the paper. Quote: “The questionnaire was designed to collect information about age, sex, educational level, birth order, number of siblings, marital status, number of children, occupation and work

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Individual - Nasr 2009

(Continued)

status, and to gather details about the illness (age at onset, number of admissions in hospital, number of relapses, family history of mental illness and so on). Information on age, sex, educational level, number of siblings, marital status, number of children, occupation and work status is reported.” Other bias

Unclear risk

Funding not stated.

Unclear - Li 2005 Methods

Allocation: randomised. Blinding: not stated. Duration: 8 weeks intervention + 3 months follow-up. Setting: Kangning Hospital, Shenzhen City, China.

Participants

Diagnosis: schizophrenia (CCMD-3-R). n = 286. Age: mean ~ 32.5 years, SD ~ 17.2 years. Sex: male and female. History: < 10 years. Exclusion: with combined other mental health problem, or if their conditions are obviously deteriorating

Interventions

1. Psychoeducation: introduce patients to i. background of prescribed medication; ii. importance of taking medication; iii. review on benefit of medication; iv. discussion on schizophrenia as an illness; v. medication management after discharge; frequency 1/week. n = 143 2. Routine health education:provided as a part of standard care. n = 143

Outcomes

Compliance: with medication and follow up (leaving the study early) Unable to use Compliance: with medication continuous data - derived from unpublished scale

Notes Risk of bias Bias

Authors’ judgement

Support for judgement

Random sequence generation (selection Unclear risk bias)

Randomisation method not stated.

Allocation concealment (selection bias)

Not stated.

Unclear risk

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Unclear - Li 2005

(Continued)

Blinding of participants and personnel Unclear risk (performance bias) All outcomes

Not stated.

Blinding of outcome assessment (detection Unclear risk bias) All outcomes

Not stated.

Incomplete outcome data (attrition bias) All outcomes

High risk

Those leaving early were excluded from the analysis.

Selective reporting (reporting bias)

Low risk

All measured outcomes reported.

Other bias

Low risk

None obvious.

Diagnosis CCMD-3 = Chinese Classification of Mental Disorders Version 3 DSM-III = Diagnostic and Statistical Manual of Mental disorders, third edition DSM-IV = Diagnostic and Statistical Manual of Mental disorders, fourth edition ICD = International Classification of Diseases Mental state: BDI = Beck Depression Inventory BPRS = Brief Psychiatric Rating Scale GWB = General Well-being Schedule MADRS = Montgomery-Åsberg Depression Rating Scale PANSS = Positive and Negative Syndrome Scale SANS = Scale for the Assessment of Negative Symptoms SAPS = Scale for the Assessment of Positive Symptoms SAS = Zung Self-Rating Anxiety Scale SDS = Zung Self-Rating Depression Scale SES = Rosenberg Self-esteem Scale Social functioning MRSS = Morningside Rehabilitation Status Scale NOSIE = Nurses’ Observation Scale for InPatient Evaluation SDSS = Social Disability Screening Schedule Global state GAF = Global Assessment of Functioning GAS = Global Assessment Scale Satisfaction with care CSQ = Client Satisfaction Questionnaire-8 VSSS = Verona Service Satisfaction Scale Quality of life FAD = Family Assessment Device FBIS = Family Burden Interview Schedule MSQoL = Modular System of Quality of Life-54 SF-36 = Short Form 36 GQOLI-74 = General Quality of Life Inventory-74 Knowledge Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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FQ = Family Questionnaire ITAQ = Insight Treatment Attitude Questionnaire KASI = Knowledge About Schizophrenia Inventory KSQ = Knowledge of Schizophrenia Questionnaire OMI = Opinions About Mental Illness SAUMD = Scale to Assess Unawareness of Mental Disorder UMQ = Understanding of medication questionnaire Miscellaneous CBT = cognitive behavioural therapy ITT = intention-to-treat SD = standard deviation

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Carra 2010

Allocation: randomised. Patients: schizophrenia Intervention: 24 sessions of informative programme versus 24 sessions of informative programme plus 48 sessions of supportive group programme

Chabannes 2009

Allocation: randomised. Patients: schizophrenia. Intervention: 21 sessions of psychoeducational programme versus 21sessions of programme delivering usual information on the disease

Cheng 2005

Allocation: randomised. Patients: schizophrenia, however, the participants were only family members of the patients Intervention: 10 weekly psychoeducation sessions based on the routine care versus routine care

Chien 2013

Allocation: randomised. Patients: schizophrenia. Intervention: 24-week psychoeducation programme contains elements of interpersonal skills training versus 24-week mutual support group versus standard care

Fries 2003

Allocation: randomised controlled trial. Patients: schizophrenic and schizoaffective disorders. Intervention: psychoeducative coping oriented therapy versus supportive discussion and problem-solving training

Hamann 2006

Allocation: randomised. Patients: schizophrenia. Intervention: the ’decision aid’ intervention employed in this trial simply provides information about the illness, but it lacks of core elements of psychoeducation; the control group was routine care

Magliano 2004

Allocation:randomised. Patients: Participants are families of patients with schizophrenia. Intervention: psychoeducation family intervention versus routine care

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(Continued)

McFarlane 1995

Allocation: randomised Patients: schizophrenia, schizoaffective disorder, or schizophreniform disorders Intervention: assertive community treatment combined with psychoeducational multifamily treatment group versus assertive community treatment combined with crisis family intervention; psychoeducation is given only as one element of a care package, which includes other elements such as skills training and family support

O’Callaghan 2009

Allocation: randomised. Patients: schizophrenia. Intervention: psychoeducation for cares, rather than for patients; psychoeducation versus non specific group for carers or treatment as usual

Pfammatter 1999

Allocation: randomised Patients: people with schizophrenic and schizoaffective disorders Intervention: coping oriented therapy, not psychoeducation, no more details

Pitschel-Walz 2013

Allocation:randomised. Patients: schizophrenia. Intervention: cognitive training versus occupational therapy

Posner 1992

Allocation: randomised. Patients: schizophrenia. Intervention: Each patient was asked to name an individual family member with whom he or she has the closest contact, the family members participated in this trial and were randomly assigned to either the psychoeducational support-group or wait-list group

Ran 2003

Allocation: cluster randomised trial. Participants: people with schizophrenia, their families did not attend this trial Intervention: participants were randomly assigned to three groups: i) drug treatment plus psychoeducational family intervention; ii) drug treatment only or iii) no interventions which means medications were not neither encouraged or discouraged

Rotondi 2005

Allocation: randomised. Participants: people with schizophrenia or schizoaffective disorder Intervention: Telehealth Intervention group includes: three online therapy groups:family members/support persons only (FTG), (b) persons with schizophrenia only (PWSTG), and (c) multifamily therapy group for all intervention participants (MFTG); participants in the control group received usual care

Schlosser 2012

Allocation: not randomised.

Shin 2002

Allocation: randomised Participants: people with schizophrenia Intervention: standard length psychoeducation (10 sessions) vs supportive therapy

Sibitz 2007

Allocation: randomised Participants: people with schizophrenia or schizoaffective disorder Intervention: patients received 9 weeks of psychoeducation before they were randomised to receive 9 months of booster sessions on a monthly basis. Essentially, the intervention is booster sessions vs no booster sessions

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(Continued)

Xiang 1994

Allocation: randomised Patients: people with schizophrenia and their family members Intervention: drug treatment plus psychoeducational family intervention versus drug treatment only; however, only family members of received the psychoeducation; all patients received drug therapy

Ying 2006

Allocation: randomised. Patients: people with schizophrenia and their family members Intervention: psychoeducational family intervention plus drug therapy versus drug therapy alone; psychoeducation included crisis intervention and predominantly to educate family members of the knowledge of schizophrenia and its treatment and rehabilitation

Characteristics of studies awaiting assessment [ordered by study ID] Bechdolf 2000 Methods

See notes below

Participants Interventions Outcomes Notes

Foreign language paper, awaiting translation.

Cormier 1995 Methods

Allocation: randomised. Blindness: not stated. Duration: 2 years (intervention 10 sessions over 20 weeks).

Participants

Diagnosis: schizophrenia n = 95 Age: not stated Sex: not stated History: not stated Included: not stated Exclusion: not stated

Interventions

1. Psychoeducation (n = 29). 2. Leisure activates (n = 26). 3. Usual care, support therapy with their psychiatrist (n = 40)

Outcomes

None listed.

Notes

Conference abstract only; no data available - more information needed

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Eguiluz 1998 Methods

Allocation: unclear

Participants

Diagonosis:Schizophrenia

Interventions

1.Psychoeducational group 2.Control group

Outcomes

Readmission rates

Notes

Full text is foreign language

Hahlweg 1997 Methods

See notes below

Participants Interventions Outcomes Notes

German language article - awaiting classification.

Hornung 1998a Methods

Allocation: unclear

Participants

Diagnosis: schizophrenia n = 131

Interventions

1. Psychoeducation (10 sessions) 2. Control group

Outcomes

Compliance Knoledge about medication Confidence in medication

Notes

Paper in German - awaiting translation.

Kissling 2007 Methods

Allocation: randomised Location: Germany

Participants

Diagnosis:Schizophrenia or schizoaffective disorder, n = 896 Inclusion criteria: Schizophrenia or schizoaffective disorder (ICD-10); age 18 to 67 years; hospitalised or treated in a day care clinic Exclusion criteria: More than 12 months of hospitalisation within the last two years; substance-dependency (principal

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Kissling 2007

(Continued)

diagnosis); mental retardation ICD-10; fluency of German language Interventions

1. Psychoeducation by professionals 2. Psychoeducation by peer-moderators 3. Video-education

Outcomes

Rehospitalisation rate2. Rehospitalisation days Resulting costs per patient Cost-benefit-analysis of the different interventions Compliance Compliance self-assessment (MARS/ DAI) Knowledge of illness Attitude towards illness Quality of life ( WHOQOL-BREF) Satisfaction questionnaire (ZUF-8) Duration of consultation time Dealing with mental illness (FMQ,BDI)

Notes

Funded by Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany) (grant ref: 01GL0509), no access to the study result. Contacted author and awaiting for full text PDF

Lacruz 1999 Methods

Allocation: randomly assigned

Participants

Diagnosis: Schizophrenic patients and their key relatives n = 70

Interventions

1.Family intervention programmes with fundamental component of educational module 2.A different family intervention

Outcomes

KASI

Notes

Full text is in foreign language, awaiting for translation.

Mihai 2005 Methods

Allocation: randomised

Participants

Diagnosis: schizophrenia. n = 60 Inclusion: Aged 18-60 years; Hospitalised in the Psychiatric Clinic II Tg. Mures, Romania Exclusion: Schizophrenia and affective disorder

Interventions

1. Mediacation with psychoeducation, n = 30. 2. Medication only, n = 30.

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Mihai 2005

(Continued)

Outcomes

BPRS CGI Qustionare about attitude and compliance

Notes

Abstract: no contact information

Motlova 2002 Methods

Unknown.

Participants Interventions Outcomes Notes

We only have the title of this study, which seems relevant to this review. However, we are still seeking for the full text publication

Nischk 2011 Methods

Allocation: randomly assigned

Participants

Diagonosis: acute psychotic patients diagnosed by ICD-10 F2 n = 57.

Interventions

1.Brief psychoeducation and treatment as usual 2.Treatment as usual

Outcomes

Knowledge gain Insight Illness perception

Notes

Full text is in foreign language, awaiting for translation.

Pitschel-Walz 1993 Methods

Unknown.

Participants Interventions Outcomes Notes

We only have the title of this study, which seems relevant to this review. However, we are still seeking for the full text publication

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Pitschel-Walz 1997 Methods

Unknown.

Participants Interventions Outcomes Notes

We only have the title of this study, which seems relevant to this review. However, we are still seeking for the full text publication

Poplawska 2004 Methods

Allocation: randomly assigned Location: Department of Psychiatry of Medical Academy in Bialystok

Participants

Diagnosis: schizophrenic and depressive patients n = 52

Interventions

1.Medication and psychoeducation 2.Medication without psychoeducation

Outcomes

BPRS BNS IMHC 2000 Raskin/Covi Scale DAI-10

Notes

Full text is in foreign language, awaiting for translation.

Schonell 1995 Methods

Allocation: randomised controlled study.

Participants

Diagnosis: schizophrenic/schizophreniform disorder n = 54

Interventions

1. Psycoeducational training on patients knowledge about their illness, twice a week for one hour over a period of four weeks 2. Training of social competence, twice a week for one hour over a period of four weeks

Outcomes

Knowledge questionnaire

Notes

Only abstract is available, awaiting for full text.

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Spencer 1988 Methods

Allocation: randomised controlled study. Location: Acute care unit of Psyne Whitney Clinic.

Participants

Diagnosis: schizophrenic/schizophreniform disorder, schizophrenic,major affective disorder, other DSM-III axis I diagnoses n = 186 Inclusion criteria: no further information Exclusion criteria: no further information. Dropouts: 13 family treatment and 4 comparison were dropped from the study because their stays in the hospital were too short, at 6-month follow-up, 168 patients completed the treatment

Interventions

1.Standard hospital treatment + Family intervention (education the nature of illness and its treatment) 2.Standard hospital treatment

Outcomes

GAS Clinical significance( defined by GAS scores two or more standard deviations above the pretreatment mean) Role Performance Treatment Scale (assesses patient level of functioning, interrater reliability was tested)

Notes

Supported in part by biomedical research support grant RR-05396 from the National Institutes of Health to Cornell University Medical Centre Data (at 6 months and 18 months) are also not available Reason for awaiting for assessment is that the paper described the family intervention as a ’brief psychoeducational and problem-focused intervention’, but without further description on the detail and length or frequency of the intervention. We are currently trying to contact the author for clarification

Tarrier 2000 Methods

Randomised controlled trial

Participants

Patients with 2-year history of schizophrenia and their families

Interventions

No information

Outcomes

Patient Clinical and symptom variables Needs assessment Carer Psychological morbidity Need assessment service use Economic analysis

Notes

Registered trial Contact author Tarrier Telephone: 0161 291 4431 Fax: 0161 291 3814 E-mail: [email protected]

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Wirshing 2000 Methods

Allocation: randomly assigned

Participants

Diagonosis: schizophrenia or schizoaffective disorder (diagnosed by DSM-IV)

Interventions

1. Community Re-Entry Program (CREP) (n = 47) 2. A standard series of Illness Education Classes (n = 47)

Outcomes

Knowledge of Illness pertinent issues

Notes

This is suspected to be the same study as Wirshing 2002. Although the N numbers in each treatment arm differs in the two trials, the results reported in the abstracts are the same. We are currently trying to contact author to obtain full text of both publications and for clarification on their associations

Wirshing 2002 Methods

Allocation: randomly assigned

Participants

Diagonosis: schizophrenia or schizoaffective disorder (diagnosed by DSM-IV)

Interventions

1. Community Re-Entry Program (CREP) (n = 39) 2. A standard series of Illness Education Classes(n = 41)

Outcomes

Wisconsin Card Sorting Test California Verbal Learning Test Continuous Performance Task Digit Span Distractibility Test BPRS Schedule of Assessment for Negative Symptoms Global Assessment of Functioning

Notes

This is suspected to be the same study as Wirshing 2000. Although the N numbers in each treatment arm differs in the two trials, the results reported in the abstracts are the same. We are currently trying to contact author to obtain full text of both publications and for clarification on their associations

BDI = Beck Depression Inventory BPRS = Brief Psychiatric Rating Scale BNS = Brief Negative Scale DAI = Drug Attitude Inventory DSM = Diagnostic and Statistical Manual of Mental Disorders DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, fourth edition FMQ = Mantonakis, Family Member Questionnaire GAS = Global Assessment Scale ICD = International Classification of Diseases IMHC 2000 = International Mental Health Counselor 2000 Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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KASI = Knowledge About Schizophrenia Inventory MARS = Medication Adherence Rating Scale PANSS = Positive and Negative Syndrome Scale WHOQOL = World Health Organisation Quality Of Life

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DATA AND ANALYSES

Comparison 1. ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION

Outcome or subgroup title 1 Compliance: 1a. With medication - non-compliance 1.1 short term 1.2 medium term 2 Compliance: 1b. With medication - partial compliance (medium term) 3 Compliance: 1c. With medication - average compliance with medication(data skewed) 3.1 single session - average compliance with medication (SAI sub-scale endpoint score, high = good) 3.2 three sessions - average compliance with medication (SAI sub-scale endpoint score, high = good) 4 Compliance: 1d. With medication - very good/ good compliance (numberic compliance scale) 4.1 Medium term 4.2 long term - 1 years 4.3 long term - 2 years 5 Compliance: 2a. With follow-up - loss to follow-up for any reason 5.1 short term - loss to follow-up for any reason 5.2 short term- received intervention but left the study early 5.3 medium term - loss to follow-up for any reason 5.4 long term - loss to follow-up for any reason (by 1 year) 5.5 long term - loss to follow-up for any reason (by 2 years)

No. of studies

No. of participants

4 3 1 1

448 118 118

1

Statistical method

Effect size

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

0.63 [0.41, 0.96] 0.17 [0.05, 0.54] 0.68 [0.39, 1.18]

Other data

No numeric data

Other data

No numeric data

Other data

No numeric data

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

1 1 1 8

236 236 236

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

1.05 [0.93, 1.18] 1.39 [1.16, 1.66] 1.46 [1.20, 1.76] Subtotals only

1

30

Risk Ratio (M-H, Fixed, 95% CI)

1.0 [0.24, 4.18]

1

67

Risk Ratio (M-H, Fixed, 95% CI)

3.06 [0.17, 56.70]

4

322

Risk Ratio (M-H, Fixed, 95% CI)

0.74 [0.50, 1.09]

2

386

Risk Ratio (M-H, Fixed, 95% CI)

1.19 [0.83, 1.72]

2

387

Risk Ratio (M-H, Fixed, 95% CI)

0.83 [0.62, 1.11]

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5.6 long term - loss to follow-up for any reason (by 5 years or more) 5.7 long term- received intervention but left the study early 6 Relapse: 1. Relapse for any reason 6.1 medium term 6.2 long term 6.3 long term (at 5 years follow-up) 7 Relapse: 2. Relapse with readmission 7.1 medium term 7.2 long term 8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales 8.1 short term (ITAQ/KSQ, high = favourable) 8.2 medium term (ITAQ, high = favourable) 9 Knowledge: 1b. Average change (UMQ, high = good, data skewed) 9.1 single session psychoeducation 9.2 three session psychoeducation 10 Knowledge: 1c. Average endpoint (ITAQ, high = good, data skewed) (short term) 11 Knowledge: 2. Average endpoint scores (SAUMD, high = poor) (short term) 12 Global state: 2. Average endpoint scale score 12.1 short term (GAF/GAS, high = good) 12.2 medium term (GAF/GAS, high = good) 12.3 long term at 2 years(GAS, high = good) 12.4 long term at 5 years or more (GAS, high = good) 13 Service utilisation: rehospitalisation 13.1 medium term 13.2 long term

1

124

Risk Ratio (M-H, Fixed, 95% CI)

0.73 [0.44, 1.21]

1

124

Risk Ratio (M-H, Fixed, 95% CI)

0.58 [0.33, 1.01]

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

0.70 [0.52, 0.93] 0.85 [0.59, 1.22] 0.89 [0.73, 1.08]

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

5 4 1 1

406 124 124

1 1 1 2

124 124

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

0.85 [0.59, 1.22] 0.83 [0.64, 1.08] Subtotals only

2

97

Mean Difference (IV, Fixed, 95% CI)

7.39 [4.94, 9.83]

1

73

Mean Difference (IV, Fixed, 95% CI)

4.83 [1.51, 8.15]

Other data

No numeric data

Other data

No numeric data

Other data

No numeric data

Other data

No numeric data

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1

41

Mean Difference (IV, Fixed, 95% CI)

-2.64 [-12.74, 7.46]

2

101

Mean Difference (IV, Fixed, 95% CI)

-0.50 [-5.48, 4.47]

1

59

Mean Difference (IV, Fixed, 95% CI)

-6.70 [-13.38, -0.02]

1

60

Mean Difference (IV, Fixed, 95% CI)

-3.80 [-8.04, 0.44]

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

0.88 [0.43, 1.79] 0.22 [0.05, 1.00]

2 2 1

188 141

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14 Mental state: 1a. Global average total endpoint scale scores (BPRS, high = poor) 14.1 short term 14.2 medium term 15 Mental state: 1b. Global average change scale scores (GWB/SES, high = good) (medium term) 15.1 General Well-being Schedule(GWB) 15.2 Rosenberg Self-esteem Scale (SES) 16 Mental state: 1c. Global average total endpoint scale scores (BPRS, high = poor, data skewed) 16.1 short term 16.2 medium term 16.3 long term 17 Mental state: 2a. Specific symptoms - short term 17.1 anxiety 17.2 depression 18 Mental state: 2b. specific symptoms - average total endpoint scale score (high = poor) (short term) 18.1 anxiety-SAS 18.2 depression-SDS 19 Mental state: 2c. Specific symptoms - average total endpoint scale scores (MADRS, high = poor, data skewed) (short term) 20 Social functioning: 1a. Average change scores on various scales (high = poor) (medium term) 20.1 MRSS 20.2 SDSS 21 Expressed emotion: Participants with high EE relatives (FQ) 21.1 short term - at end of interventions 21.2 medium term 22 Expressed emotion for relatives: Average change scores on FQ scales (high = good) 23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good) 23.1 short term

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

-2.70 [-4.84, -0.56] -5.36 [-6.77, -3.95] Totals not selected

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

Other data

No numeric data

1

Other data Other data Other data Risk Ratio (M-H, Fixed, 95% CI)

No numeric data No numeric data No numeric data Totals not selected

1 1 1

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0] 0.0 [0.0, 0.0] Totals not selected

1 1

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Other data

0.0 [0.0, 0.0] 0.0 [0.0, 0.0] No numeric data

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1 1 1

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

0.0 [0.0, 0.0] 0.0 [0.0, 0.0] Totals not selected

1

Risk Ratio (M-H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1 1

Risk Ratio (M-H, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0] Totals not selected

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1 1 1

60 120

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23.2 medium term 24 Quality of life: 1b. Average endpoint scores (FAD, high = poor) 24.1 short term 24.2 medium term 25 Quality of life: 1c. Average endpoint scores (FBIS, high = poor, data skewed) 25.1 Financial 25.2 Routine 25.3 Leisure 25.4 Interaction 25.5 Physical health 25.6 Psychological health 26 Satisfaction with mental health services: 1. Average change score (VSS, high = good) (short term) 26.1 patients’ satisfaction 26.2 relatives’ satisfaction 27 Satisfaction with mental health services: 2. Average change (VSS Scale, high = good) (long term at 1 year) 27.1 patients’ satisfaction with relatives’ involvement - mean change 27.2 relatives’ involvement satisfaction 27.3 relatives’ efficacy satisfaction 27.4 relatives’ intervention satisfaction 28 Patients’ satisfaction with mental health services: average endpoint scores (CSQ, high = good) (short term) 29 Adverse event: Death 29.1 medium term 29.2 long term

1 1

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0] Totals not selected

1 1

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Other data

0.0 [0.0, 0.0] 0.0 [0.0, 0.0] No numeric data

1

Other data Other data Other data Other data Other data Other data Mean Difference (IV, Fixed, 95% CI)

No numeric data No numeric data No numeric data No numeric data No numeric data No numeric data Totals not selected

1 1 1

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0] 0.0 [0.0, 0.0] Totals not selected

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only 0.99 [0.15, 6.65] 0.85 [0.05, 13.30]

3 2 1

154 124

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Comparison 2. ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT

Outcome or subgroup title 1 Compliance: With medication (numberic compliance scale, high = good) 1.1 short term 1.2 medium term 1.3 long term 2 Relapse: Relapse for any reason (medium term) 3 Service utilisation: hospitalisation (long term) 4 Mental state: Specific - average endpoint PANSS scores (high = poor) 4.1 short term - positive score 4.2 short term - negative score 4.3 short term - general score 4.4 medium term - positive score 4.5 medium term - negative score 4.6 medium term - general score 4.7 long term - positive score 4.8 long term - negative score 4.9 long term - general score 5 Quality of life: Average endpoint MSQoL-54 score (high = good) 5.1 short term 5.2 medium term

No. of studies

No. of participants

1

Statistical method

Effect size

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

-0.20 [-0.42, 0.02] -0.30 [-0.70, 0.10] -0.5 [-1.05, 0.05] Totals not selected

1

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1 1 1 1

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0] 0.0 [0.0, 0.0] 0.0 [0.0, 0.0] 0.0 [0.0, 0.0]

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1 1 1 1

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0] 0.0 [0.0, 0.0] 0.0 [0.0, 0.0] Totals not selected

1 1

Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0] 0.0 [0.0, 0.0]

1 1 1 1

88 88 41

Comparison 3. SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION

Outcome or subgroup title 1 Compliance: 1a. With medication - non-compliance 1.1 group - short term 1.2 unclear - short term 1.3 both - medium term

No. of studies

No. of participants

4 2 1 1

162 286 118

Statistical method

Effect size

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

0.5 [0.18, 1.40] 0.67 [0.42, 1.06] 0.17 [0.05, 0.54]

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2 Compliance: 1b. With follow up - loss to follow-up for any reason 2.1 both - short term - loss to follow-up for any reason 2.2 group - medium term loss to follow-up for any reason 2.3 individual - medium term - loss to follow-up for any reason 2.4 group - long term - loss to follow-up for any reason (by 1 year) 2.5 group - long term - loss to follow-up for any reason (by 2 years) 2.6 group - long term - loss to follow-up for any reason (by 5 years or more) 3 Relapse: 1. Relapse for any reason 3.1 group - medium term 3.2 individual - medium term 3.3 group - long term 3.4 group - long term (at 5 years follow-up)

7

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

1

30

Risk Ratio (M-H, Fixed, 95% CI)

1.0 [0.24, 4.18]

3

208

Risk Ratio (M-H, Fixed, 95% CI)

0.70 [0.45, 1.09]

1

114

Risk Ratio (M-H, Fixed, 95% CI)

0.87 [0.37, 2.03]

2

386

Risk Ratio (M-H, Fixed, 95% CI)

1.19 [0.83, 1.72]

1

124

Risk Ratio (M-H, Fixed, 95% CI)

0.70 [0.43, 1.15]

1

124

Risk Ratio (M-H, Fixed, 95% CI)

0.73 [0.44, 1.21]

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)

0.61 [0.43, 0.89] 0.87 [0.55, 1.38] 0.85 [0.59, 1.22] 0.89 [0.73, 1.08]

5 3 1 1 1

292 114 124 124

Comparison 4. SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT

Outcome or subgroup title 1 Relapse: Relapse for any reason (medium term) 2 Relapse: Relapse for any reason (medium term)-without assumption

No. of studies

No. of participants

Statistical method

Effect size

1

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

1

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

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Comparison 5. SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION No. of studies

Outcome or subgroup title 1 Compliance: 1a. With medication - non-compliance 1.1 short term - with high risk trials 1.2 short term - without high risk trials

No. of participants

3

Statistical method

Effect size

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

3

448

Risk Ratio (M-H, Fixed, 95% CI)

0.63 [0.41, 0.96]

1

60

Risk Ratio (M-H, Fixed, 95% CI)

0.67 [0.12, 3.71]

Analysis 1.1. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 1 Compliance: 1a. With medication - non-compliance

Brief Psychoeducation

Routine care

n/N

n/N

Group - Dai 2007

3/51

7/51

15.2 %

0.43 [ 0.12, 1.57 ]

Group - Zhang 2006

2/30

3/30

6.5 %

0.67 [ 0.12, 3.71 ]

24/143

36/143

78.3 %

0.67 [ 0.42, 1.06 ]

224

224

100.0 %

0.63 [ 0.41, 0.96 ]

3/59

18/59

100.0 %

0.17 [ 0.05, 0.54 ]

59

59

100.0 %

0.17 [ 0.05, 0.54 ]

Study or subgroup

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 short term

Unclear - Li 2005

Subtotal (95% CI)

Total events: 29 (Brief Psychoeducation), 46 (Routine care) Heterogeneity: Chi2 = 0.40, df = 2 (P = 0.82); I2 =0.0% Test for overall effect: Z = 2.15 (P = 0.032) 2 medium term Both - Liu 2004

Subtotal (95% CI)

Total events: 3 (Brief Psychoeducation), 18 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 3.01 (P = 0.0026) Test for subgroup differences: Chi2 = 4.41, df = 1 (P = 0.04), I2 =77%

0.02

0.1

Favours psychoeducation

1

10

50

Favours routine care

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Analysis 1.2. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With medication - partial compliance (medium term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 2 Compliance: 1b. With medication - partial compliance (medium term)

Study or subgroup

Both - Liu 2004

Total (95% CI)

Brief Psychoeducation

Routine care

n/N

n/N

15/59

22/59

100.0 %

0.68 [ 0.39, 1.18 ]

59

59

100.0 %

0.68 [ 0.39, 1.18 ]

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

Total events: 15 (Brief Psychoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.37 (P = 0.17) Test for subgroup differences: Not applicable

0.2

0.5

Favours psychoeducation

1

2

5

Favours routine care

Analysis 1.3. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 3 Compliance: 1c. With medication - average compliance with medication(data skewed). Compliance: 1c. With medication - average compliance with medication(data skewed)

Study

Intervention

Mean

SD

N

single session - average compliance with medication (SAI sub-scale endpoint score, high = good) Individual - Macpherson Psychoeducation 1996

2.6

1.2

22

Individual - Macpherson Routine care 1996

2.1

1.3

20

three sessions - average compliance with medication (SAI sub-scale endpoint score, high = good) Individual - Macpherson Psychoeducation 1996

2.18

1.3

22

Individual - Macpherson Routine care 1996

2.1

1.3

20

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Analysis 1.4. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 4 Compliance: 1d. With medication - very good/ good compliance (numberic compliance scale). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 4 Compliance: 1d. With medication - very good/ good compliance (numberic compliance scale)

Study or subgroup

Brief Psychoeducation

Routine care

n/N

n/N

106/125

90/111

100.0 %

1.05 [ 0.93, 1.18 ]

125

111

100.0 %

1.05 [ 0.93, 1.18 ]

100/125

64/111

100.0 %

1.39 [ 1.16, 1.66 ]

125

111

100.0 %

1.39 [ 1.16, 1.66 ]

100/125

61/111

100.0 %

1.46 [ 1.20, 1.76 ]

125

111

100.0 %

1.46 [ 1.20, 1.76 ]

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 Medium term Group - Bauml 2007

Subtotal (95% CI)

Total events: 106 (Brief Psychoeducation), 90 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.75 (P = 0.45) 2 long term - 1 years Group - Bauml 2007

Subtotal (95% CI)

Total events: 100 (Brief Psychoeducation), 64 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 3.53 (P = 0.00042) 3 long term - 2 years Group - Bauml 2007

Subtotal (95% CI)

Total events: 100 (Brief Psychoeducation), 61 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 3.88 (P = 0.00011)

0.5

0.7

Favours routine care

1

1.5

2

Favours psychoeducation

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Analysis 1.5. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 5 Compliance: 2a. With follow-up - loss to follow-up for any reason. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 5 Compliance: 2a. With follow-up - loss to follow-up for any reason

Study or subgroup

Brief Psychoeducation

Routine care

n/N

n/N

3/15

3/15

100.0 %

1.00 [ 0.24, 4.18 ]

15

15

100.0 %

1.00 [ 0.24, 4.18 ]

3/47

0/20

100.0 %

3.06 [ 0.17, 56.70 ]

47

20

100.0 %

3.06 [ 0.17, 56.70 ]

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 short term - loss to follow-up for any reason Both - Tom 1989

Subtotal (95% CI)

Total events: 3 (Brief Psychoeducation), 3 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.0 (P = 1.0) 2 short term- received intervention but left the study early Individual - Macpherson 1996

Subtotal (95% CI)

Total events: 3 (Brief Psychoeducation), 0 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.75 (P = 0.45) 3 medium term - loss to follow-up for any reason Group - Coyle 1988

4/17

1/21

2.0 %

4.94 [ 0.61, 40.19 ]

Group - Merinder 1999

6/24

9/22

21.5 %

0.61 [ 0.26, 1.44 ]

Individual - Cunningham 2001

9/61

9/53

22.0 %

0.87 [ 0.37, 2.03 ]

15/67

22/57

54.4 %

0.58 [ 0.33, 1.01 ]

169

153

100.0 %

0.74 [ 0.50, 1.09 ]

6/75

9/75

22.7 %

0.67 [ 0.25, 1.78 ]

44/125

29/111

77.3 %

1.35 [ 0.91, 2.00 ]

200

186

100.0 %

1.19 [ 0.83, 1.72 ]

19/67

23/57

36.8 %

0.70 [ 0.43, 1.15 ]

46/152

37/111

63.2 %

0.91 [ 0.64, 1.30 ]

Group - Hornung 1995

Subtotal (95% CI)

Total events: 34 (Brief Psychoeducation), 41 (Routine care) Heterogeneity: Chi2 = 4.23, df = 3 (P = 0.24); I2 =29% Test for overall effect: Z = 1.51 (P = 0.13) 4 long term - loss to follow-up for any reason (by 1 year) Group - Aguglia 2007 Group - Bauml 2007

Subtotal (95% CI)

Total events: 50 (Brief Psychoeducation), 38 (Routine care) Heterogeneity: Chi2 = 1.72, df = 1 (P = 0.19); I2 =42% Test for overall effect: Z = 0.95 (P = 0.34) 5 long term - loss to follow-up for any reason (by 2 years) Group - Hornung 1995 Group - Bauml 2007

0.002

0.1

Favours psychoeducation

1

10

500

Favours routine care

(Continued . . . )

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87

(. . . Study or subgroup

Continued)

Brief Psychoeducation

Routine care

n/N

n/N

219

168

100.0 %

0.83 [ 0.62, 1.11 ]

19/67

22/57

100.0 %

0.73 [ 0.44, 1.21 ]

67

57

100.0 %

0.73 [ 0.44, 1.21 ]

15/67

22/57

100.0 %

0.58 [ 0.33, 1.01 ]

67

57

100.0 %

0.58 [ 0.33, 1.01 ]

Subtotal (95% CI)

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

Total events: 65 (Brief Psychoeducation), 60 (Routine care) Heterogeneity: Chi2 = 0.68, df = 1 (P = 0.41); I2 =0.0% Test for overall effect: Z = 1.24 (P = 0.21) 6 long term - loss to follow-up for any reason (by 5 years or more) Group - Hornung 1995

Subtotal (95% CI)

Total events: 19 (Brief Psychoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.20 (P = 0.23) 7 long term- received intervention but left the study early Group - Hornung 1995

Subtotal (95% CI)

Total events: 15 (Brief Psychoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.93 (P = 0.054)

0.002

0.1

Favours psychoeducation

1

10

500

Favours routine care

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Analysis 1.6. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 6 Relapse: 1. Relapse for any reason. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 6 Relapse: 1. Relapse for any reason

Brief Psychoeducation

Routine care

n/N

n/N

6/44

8/37

12.1 %

0.63 [ 0.24, 1.65 ]

Group - Merinder 1999

14/24

15/22

21.9 %

0.86 [ 0.55, 1.33 ]

Group - Razali 1995

11/85

23/80

33.1 %

0.45 [ 0.23, 0.86 ]

Individual - Cunningham 2001

22/61

22/53

32.9 %

0.87 [ 0.55, 1.38 ]

214

192

100.0 %

0.70 [ 0.52, 0.93 ]

30/67

30/57

100.0 %

0.85 [ 0.59, 1.22 ]

67

57

100.0 %

0.85 [ 0.59, 1.22 ]

48/67

46/57

100.0 %

0.89 [ 0.73, 1.08 ]

67

57

100.0 %

0.89 [ 0.73, 1.08 ]

Study or subgroup

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 medium term Group - Chan 2007

Subtotal (95% CI)

Total events: 53 (Brief Psychoeducation), 68 (Routine care) Heterogeneity: Chi2 = 3.46, df = 3 (P = 0.33); I2 =13% Test for overall effect: Z = 2.45 (P = 0.014) 2 long term Group - Hornung 1995

Subtotal (95% CI)

Total events: 30 (Brief Psychoeducation), 30 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.87 (P = 0.38) 3 long term (at 5 years follow-up) Group - Hornung 1995

Subtotal (95% CI)

Total events: 48 (Brief Psychoeducation), 46 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.18 (P = 0.24) Test for subgroup differences: Chi2 = 1.85, df = 2 (P = 0.40), I2 =0.0%

0.2

0.5

1

Favours psychoeducation

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2

5

Favours routine care

89

Analysis 1.7. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 7 Relapse: 2. Relapse with readmission. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 7 Relapse: 2. Relapse with readmission

Study or subgroup

Brief Psychoeducation

Routine care

n/N

n/N

30/67

30/57

100.0 %

0.85 [ 0.59, 1.22 ]

67

57

100.0 %

0.85 [ 0.59, 1.22 ]

39/67

40/57

100.0 %

0.83 [ 0.64, 1.08 ]

67

57

100.0 %

0.83 [ 0.64, 1.08 ]

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 medium term Group - Hornung 1995

Subtotal (95% CI)

Total events: 30 (Brief Psychoeducation), 30 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.87 (P = 0.38) 2 long term Group - Hornung 1995

Subtotal (95% CI)

Total events: 39 (Brief Psychoeducation), 40 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.39 (P = 0.17)

0.01

0.1

Favours psychoeducation

1

10

100

Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

90

Analysis 1.8. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales

Study or subgroup

Brief Psychoeducation

Mean Difference

Routine care

N

Mean(SD)

N

Mean(SD)

Weight

IV,Fixed,95% CI

Mean Difference IV,Fixed,95% CI

1 short term (ITAQ/KSQ, high = favourable) Both - Tom 1989

12

23.58 (8.19)

12

16.83 (8.12)

14.0 %

6.75 [ 0.22, 13.28 ]

Group - Chan 2009

36

15.03 (5.33)

37

7.54 (6.15)

86.0 %

7.49 [ 4.85, 10.13 ]

Subtotal (95% CI)

48

100.0 %

7.39 [ 4.94, 9.83 ]

100.0 %

4.83 [ 1.51, 8.15 ]

100.0 %

4.83 [ 1.51, 8.15 ]

49

Heterogeneity: Chi2 = 0.04, df = 1 (P = 0.84); I2 =0.0% Test for overall effect: Z = 5.92 (P < 0.00001) 2 medium term (ITAQ, high = favourable) Group - Chan 2009

36

Subtotal (95% CI)

36

14.64 (6.76)

37

9.81 (7.71)

37

Heterogeneity: not applicable Test for overall effect: Z = 2.85 (P = 0.0044) Test for subgroup differences: Chi2 = 1.47, df = 1 (P = 0.22), I2 =32%

-20

-10

Favours routine care

0

10

20

Favours psychoeducation

Analysis 1.9. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 9 Knowledge: 1b. Average change (UMQ, high = good, data skewed). Knowledge: 1b. Average change (UMQ, high = good, data skewed)

Study

Intervention

Mean

SD

N

Individual - Macpherson Psychoeducation 1996

6.4

5.9

22

Individual - Macpherson Routine care 1996

1.0

2.8

20

15.00

7.4

22

single session psychoeducation

three session psychoeducation Individual - Macpherson Psychoeducation 1996

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

91

Knowledge: 1b. Average change (UMQ, high = good, data skewed)

Individual - Macpherson Routine care 1996

1.0

2.8

(Continued)

20

Analysis 1.10. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 10 Knowledge: 1c. Average endpoint (ITAQ, high = good, data skewed) (short term). Knowledge: 1c. Average endpoint (ITAQ, high = good, data skewed) (short term)

Study

Intervention

Mean

SD

N

Individual - Cunning- Brief psychoeducation ham 2001

14.5

5.5

47

Individual - Cunning- Standard care ham 2001

10.7

5.6

39

Analysis 1.11. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 11 Knowledge: 2. Average endpoint scores (SAUMD, high = poor) (short term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 11 Knowledge: 2. Average endpoint scores (SAUMD, high = poor) (short term)

Study or subgroup

Group - Chan 2007

Brief Psychoeducation

Mean Difference

Routine care

N

Mean(SD)

N

Mean(SD)

44

6.77 (2.56)

37

7.95 (3.2)

IV,Fixed,95% CI

IV,Fixed,95% CI -1.18 [ -2.46, 0.10 ]

-20

-10

Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Mean Difference

0

10

20

Favours routine care

92

Analysis 1.12. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 12 Global state: 2. Average endpoint scale score. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 12 Global state: 2. Average endpoint scale score

Study or subgroup

Brief Psychoeducation N

Mean Difference

Routine care Mean(SD)

N

Mean(SD)

Weight

IV,Fixed,95% CI

Mean Difference IV,Fixed,95% CI

1 short term (GAF/GAS, high = good) Group - Merinder 1999

Subtotal (95% CI)

22 -53.27 (17.83)

22

19 -50.63 (15.18)

100.0 %

19

-2.64 [ -12.74, 7.46 ]

100.0 % -2.64 [ -12.74, 7.46 ]

Heterogeneity: not applicable Test for overall effect: Z = 0.51 (P = 0.61) 2 medium term (GAF/GAS, high = good) Group - Hornung 1995

26

Group - Merinder 1999

22 -62.91 (16.34)

Subtotal (95% CI)

-56.1 (13)

48

35

-57.8 (8.3)

76.1 %

1.70 [ -4.00, 7.40 ]

18 -55.39 (16.35)

23.9 %

-7.52 [ -17.70, 2.66 ]

100.0 %

-0.50 [ -5.48, 4.47 ]

100.0 %

-6.70 [ -13.38, -0.02 ]

53

Heterogeneity: Chi2 = 2.40, df = 1 (P = 0.12); I2 =58% Test for overall effect: Z = 0.20 (P = 0.84) 3 long term at 2 years(GAS, high = good) Group - Hornung 1995

Subtotal (95% CI)

25

-65.2 (13.7)

25

34

-58.5 (11.8)

100.0 % -6.70 [ -13.38, -0.02 ]

34

Heterogeneity: not applicable Test for overall effect: Z = 1.97 (P = 0.049) 4 long term at 5 years or more (GAS, high = good) Group - Hornung 1995

Subtotal (95% CI)

25

25

-59.8 (9.1)

35

-56 (6.9)

35

100.0 %

-3.80 [ -8.04, 0.44 ]

100.0 %

-3.80 [ -8.04, 0.44 ]

Heterogeneity: not applicable Test for overall effect: Z = 1.76 (P = 0.079) Test for subgroup differences: Chi2 = 2.27, df = 3 (P = 0.52), I2 =0.0%

-50

-25

Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

0

25

50

Favours psychoeducation

93

Analysis 1.13. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 13 Service utilisation: rehospitalisation. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 13 Service utilisation: rehospitalisation

Brief Psychoeducation

Routine care

n/N

n/N

Group - Aguglia 2007

10/75

13/75

93.6 %

0.77 [ 0.36, 1.64 ]

Group - Coyle 1988

2/17

1/21

6.4 %

2.47 [ 0.24, 24.98 ]

92

96

100.0 %

0.88 [ 0.43, 1.79 ]

Study or subgroup

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 medium term

Subtotal (95% CI)

Total events: 12 (Brief Psychoeducation), 14 (Routine care) Heterogeneity: Chi2 = 0.88, df = 1 (P = 0.35); I2 =0.0% Test for overall effect: Z = 0.36 (P = 0.72) 2 long term Group - Aguglia 2007

2/75

8/66

100.0 %

0.22 [ 0.05, 1.00 ]

Subtotal (95% CI)

75

66

100.0 %

0.22 [ 0.05, 1.00 ]

Total events: 2 (Brief Psychoeducation), 8 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.96 (P = 0.050)

0.02

0.1

Favours psychoeducation

1

10

50

Favours routine care

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94

Analysis 1.14. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 14 Mental state: 1a. Global - average total endpoint scale scores (BPRS, high = poor). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 14 Mental state: 1a. Global - average total endpoint scale scores (BPRS, high = poor)

Study or subgroup

Brief Psychoeducation

Mean Difference

Routine care

N

Mean(SD)

N

Mean(SD)

30

20.63 (4.3)

30

23.33 (4.15)

Weight

IV,Fixed,95% CI

Mean Difference IV,Fixed,95% CI

1 short term Group - Zhang 2006

Subtotal (95% CI)

30

100.0 %

30

-2.70 [ -4.84, -0.56 ]

100.0 % -2.70 [ -4.84, -0.56 ]

Heterogeneity: not applicable Test for overall effect: Z = 2.47 (P = 0.013) 2 medium term Group - Li 2003

Subtotal (95% CI)

68

20.61 (4.65)

68

52

100.0 %

25.97 (3.22)

52

-5.36 [ -6.77, -3.95 ]

100.0 % -5.36 [ -6.77, -3.95 ]

Heterogeneity: not applicable Test for overall effect: Z = 7.45 (P < 0.00001) Test for subgroup differences: Chi2 = 4.14, df = 1 (P = 0.04), I2 =76%

-10

-5

Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

0

5

10

Favours routine care

95

Analysis 1.15. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 15 Mental state: 1b. Global - average change scale scores (GWB/SES, high = good) (medium term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 15 Mental state: 1b. Global - average change scale scores (GWB/SES, high = good) (medium term)

Study or subgroup

Brief Psychoeducation N

Mean Difference

Routine care

Mean Difference

Mean(SD)

N

Mean(SD)

IV,Fixed,95% CI

IV,Fixed,95% CI

13.13 (1.78)

59

2.24 (3.81)

10.89 [ 9.82, 11.96 ]

9.11 (0.77)

59

1.11 (0.48)

8.00 [ 7.77, 8.23 ]

1 General Well-being Schedule(GWB) Both - Liu 2004

59

2 Rosenberg Self-esteem Scale (SES) Both - Liu 2004

59

-10

-5

0

Favours routine care

5

10

Favours psychoeducation

Analysis 1.16. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 16 Mental state: 1c. Global - average total endpoint scale scores (BPRS, high = poor, data skewed). Mental state: 1c. Global - average total endpoint scale scores (BPRS, high = poor, data skewed)

Study

Intervention

Mean

SD

N

Group - Merinder 1999

Psychoeducation

11.41

7.91

22

Group - Merinder 1999

Routine care

13.50

9.54

19

Group - Chan 2009

Psychoeducation

5.69

7.91

36

Group - Chan 2009

Routine care

8.81

9.58

37

Group - Chan 2009

Psychoeducation

4.5

5.11

36

Group - Chan 2009

Routine care

8.81

9.12

37

Group - Merinder 1999

Psychoeducation

8.86

6.19

22

short term

medium term

long term

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

96

(Continued)

Mental state: 1c. Global - average total endpoint scale scores (BPRS, high = poor, data skewed)

Group - Merinder 1999

Routine care

10.50

7.37

18

Analysis 1.17. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 17 Mental state: 2a. Specific symptoms - short term. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 17 Mental state: 2a. Specific symptoms - short term

Study or subgroup

Brief Psychoeducation

Routine care

n/N

n/N

11/74

22/72

0.49 [ 0.25, 0.93 ]

11/74

23/72

0.47 [ 0.25, 0.88 ]

Risk Ratio

Risk Ratio

M-H,Fixed,95% CI

M-H,Fixed,95% CI

1 anxiety Both - Zhang 2004 2 depression Both - Zhang 2004

0.01

0.1

Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

1

10

100

Favours routine care

97

Analysis 1.18. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 18 Mental state: 2b. specific symptoms - average total endpoint scale score (high = poor) (short term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 18 Mental state: 2b. specific symptoms - average total endpoint scale score (high = poor) (short term)

Study or subgroup

Brief Psychoeducation

Mean Difference

Routine care

Mean Difference

N

Mean(SD)

N

Mean(SD)

IV,Fixed,95% CI

IV,Fixed,95% CI

74

40.64 (9.87)

72

46.75 (9.42)

-6.11 [ -9.24, -2.98 ]

74

40.35 (9.47)

72

47.97 (10.75)

-7.62 [ -10.91, -4.33 ]

1 anxiety-SAS Both - Zhang 2004 2 depression-SDS Both - Zhang 2004

-50

-25

Favours psychoeducation

0

25

50

Favours routine care

Analysis 1.19. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 19 Mental state: 2c. Specific symptoms - average total endpoint scale scores (MADRS, high = poor, data skewed) (short term). Mental state: 2c. Specific symptoms - average total endpoint scale scores (MADRS, high = poor, data skewed) (short term)

Study

Intervention

Mean

SD

N

Individual - Cunning- Brief psychoeducation ham 2001

11.2

8.3

43

Individual - Cunning- Standard care ham 2001

11

10.8

39

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

98

Analysis 1.20. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 20 Social functioning: 1a. Average change scores on various scales (high = poor) (medium term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 20 Social functioning: 1a. Average change scores on various scales (high = poor) (medium term)

Study or subgroup

Brief Psychoeducation

Mean Difference

Routine care

Mean Difference

N

Mean(SD)

N

Mean(SD)

IV,Fixed,95% CI

IV,Fixed,95% CI

59

-15.07 (3.67)

59

-1.39 (2.73)

-13.68 [ -14.85, -12.51 ]

59

-2.25 (0.45)

59

-0.29 (0.22)

-1.96 [ -2.09, -1.83 ]

1 MRSS Both - Liu 2004 2 SDSS Both - Liu 2004

-10

-5

0

Favours psychoeducation

5

10

Favours routine care

Analysis 1.21. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 21 Expressed emotion: Participants with high EE relatives (FQ). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 21 Expressed emotion: Participants with high EE relatives (FQ)

Study or subgroup

Brief Psychoeducation

Routine care

n/N

n/N

10/24

14/22

0.65 [ 0.37, 1.16 ]

14/24

12/22

1.07 [ 0.64, 1.78 ]

Risk Ratio

Risk Ratio

M-H,Fixed,95% CI

M-H,Fixed,95% CI

1 short term - at end of interventions Group - Merinder 1999 2 medium term Group - Merinder 1999

0.1 0.2

0.5

Favours psychoeducation

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

1

2

5

10

Favours routine care

99

Analysis 1.22. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 22 Expressed emotion for relatives: Average change scores on FQ scales (high = good). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 22 Expressed emotion for relatives: Average change scores on FQ scales (high = good)

Study or subgroup

Brief Psychoeducation

Group - Merinder 1999

Mean Difference

Routine care

N

Mean(SD)

N

Mean(SD)

18

-0.61 (3.43)

11

2.64 (8.01)

Mean Difference

IV,Fixed,95% CI

IV,Fixed,95% CI -3.25 [ -8.24, 1.74 ]

-100

-50

0

Favours [Routine care]

50

100

Favours [Psychoeducation]

Analysis 1.23. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good)

Study or subgroup

Brief Psychoeducation

Mean Difference

Routine care

Mean Difference

N

Mean(SD)

N

Mean(SD)

IV,Fixed,95% CI

IV,Fixed,95% CI

30

17.35 (2.56)

32

16.72 (3.13)

0.63 [ -0.79, 2.05 ]

30

18.45 (2.25)

32

16.32 (2.17)

2.13 [ 1.03, 3.23 ]

1 short term Group - Lv 2007 2 medium term Group - Lv 2007

-20

-10

Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

0

10

20

Favours psychoeducation

100

Analysis 1.24. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 24 Quality of life: 1b. Average endpoint scores (FAD, high = poor). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 24 Quality of life: 1b. Average endpoint scores (FAD, high = poor)

Study or subgroup

Brief Psychoeducation

Mean Difference

Routine care

Mean Difference

N

Mean(SD)

N

Mean(SD)

IV,Fixed,95% CI

IV,Fixed,95% CI

30

71.26 (9.83)

32

71.68 (10.37)

-0.42 [ -5.45, 4.61 ]

30

63.13 (9.86)

32

69.92 (9.74)

-6.79 [ -11.67, -1.91 ]

1 short term Group - Lv 2007 2 medium term Group - Lv 2007

-20

-10

Favours psychoeducation

0

10

20

Favours routine care

Analysis 1.25. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 25 Quality of life: 1c. Average endpoint scores (FBIS, high = poor, data skewed). Quality of life: 1c. Average endpoint scores (FBIS, high = poor, data skewed)

Study

Intervention

Mean

SD

N

Financial Individual - Nasr 2009

Psychoeducation + med- 2.37 ication

1.6

52

Individual - Nasr 2009

Medication alone

3.00

1.78

56

Individual - Nasr 2009

Psychoeducation + med- 1.46 ication

1.61

52

Individual - Nasr 2009

Medication alone

2.38

1.95

56

Individual - Nasr 2009

Psychoeducation + med- 1.77 ication

2.08

52

Individual - Nasr 2009

Medication alone

2.24

56

Routine

Leisure

3.46

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Quality of life: 1c. Average endpoint scores (FBIS, high = poor, data skewed)

(Continued)

Interaction Individual - Nasr 2009

Psychoeducation + med- 1.33 ication

1.68

52

Individual - Nasr 2009

Medication alone

2.80

2.08

56

Individual - Nasr 2009

Psychoeducation + med- 1.29 ication

1.70

52

Individual - Nasr 2009

Medication alone

1.57

2.15

56

Individual - Nasr 2009

Psychoeducation + med- 1.00 ication

1.35

52

Individual - Nasr 2009

Medication alone

2.16

56

Physical health

Psychological health

1.75

Analysis 1.26. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 26 Satisfaction with mental health services: 1. Average change score (VSS, high = good) (short term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 26 Satisfaction with mental health services: 1. Average change score (VSS, high = good) (short term)

Study or subgroup

Brief Psychoeducation

Mean Difference

Routine care

Mean Difference

N

Mean(SD)

N

Mean(SD)

IV,Fixed,95% CI

IV,Fixed,95% CI

18

-9.47 (17.46)

14

-7.32 (16.48)

-2.15 [ -13.96, 9.66 ]

10

-9.56 (28.73)

7

1.25 (16.05)

-10.81 [ -32.22, 10.60 ]

1 patients’ satisfaction Group - Merinder 1999 2 relatives’ satisfaction Group - Merinder 1999

-100

-50

Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

0

50

100

Favours psychoeducation

102

Analysis 1.27. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 27 Satisfaction with mental health services: 2. Average change (VSS Scale, high = good) (long term at 1 year). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 27 Satisfaction with mental health services: 2. Average change (VSS Scale, high = good) (long term at 1 year)

Brief Psychoeducation

Study or subgroup

N

Mean Difference

Routine care Mean(SD)

N

Mean(SD)

Mean Difference

IV,Fixed,95% CI

IV,Fixed,95% CI

1 patients’ satisfaction with relatives’ involvement - mean change Group - Merinder 1999

15

-4.47 (3.13)

15

-0.12 (4.42)

-4.35 [ -7.09, -1.61 ]

11

-1.34 (5.77)

10

0.83 (3.19)

-2.17 [ -6.11, 1.77 ]

12

-1.51 (6.47)

12

0.65 (6.35)

-2.16 [ -7.29, 2.97 ]

13

-2.83 (9.54)

13

0.6 (6.91)

-3.43 [ -9.83, 2.97 ]

2 relatives’ involvement satisfaction Group - Merinder 1999 3 relatives’ efficacy satisfaction Group - Merinder 1999 4 relatives’ intervention satisfaction Group - Merinder 1999

-20

-10

0

Favours routine care

10

20

Favours psychoeducation

Analysis 1.28. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 28 Patients’ satisfaction with mental health services: average endpoint scores (CSQ, high = good) (short term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 28 Patients’ satisfaction with mental health services: average endpoint scores (CSQ, high = good) (short term)

Study or subgroup

Both - Tom 1989

Brief Psychoeducation

Mean Difference

Routine care

N

Mean(SD)

N

Mean(SD)

12

24.58 (1.85)

12

23.42 (3.75)

IV,Fixed,95% CI

IV,Fixed,95% CI 1.16 [ -1.21, 3.53 ]

-10

-5

Favours routine care

Psychoeducation (brief) for people with serious mental illness (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Mean Difference

0

5

10

Favours psychoeducation

103

Analysis 1.29. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 29 Adverse event: Death. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 29 Adverse event: Death

Brief Psychoeducation

Routine care

n/N

n/N

Group - Merinder 1999

0/24

1/22

76.4 %

0.31 [ 0.01, 7.16 ]

Individual - Nasr 2009

1/52

0/56

23.6 %

3.23 [ 0.13, 77.48 ]

Subtotal (95% CI)

76

78

100.0 %

0.99 [ 0.15, 6.65 ]

1/67

1/57

100.0 %

0.85 [ 0.05, 13.30 ]

67

57

100.0 %

0.85 [ 0.05, 13.30 ]

Study or subgroup

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 medium term

Total events: 1 (Brief Psychoeducation), 1 (Routine care) Heterogeneity: Chi2 = 1.06, df = 1 (P = 0.30); I2 =6% Test for overall effect: Z = 0.01 (P = 1.0) 2 long term Group - Hornung 1995

Subtotal (95% CI)

Total events: 1 (Brief Psychoeducation), 1 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.12 (P = 0.91) Test for subgroup differences: Chi2 = 0.01, df = 1 (P = 0.93), I2 =0.0%

0.005

0.1

Favours psychoeducation

1

10

200

Favours routine care

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Analysis 2.1. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Compliance: With medication (numberic compliance scale, high = good). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 1 Compliance: With medication (numberic compliance scale, high = good)

Study or subgroup

Brief Psychoeducation

Mean Difference

CBT

N

Mean(SD)

N

Mean(SD)

48

3.7 (0.7)

40

3.9 (0.3)

Weight

IV,Fixed,95% CI

Mean Difference IV,Fixed,95% CI

1 short term Group - Bechdolf 2004

Subtotal (95% CI)

48

40

100.0 %

-0.20 [ -0.42, 0.02 ]

100.0 %

-0.20 [ -0.42, 0.02 ]

100.0 %

-0.30 [ -0.70, 0.10 ]

100.0 %

-0.30 [ -0.70, 0.10 ]

100.0 %

-0.50 [ -1.05, 0.05 ]

100.0 %

-0.50 [ -1.05, 0.05 ]

Heterogeneity: not applicable Test for overall effect: Z = 1.79 (P = 0.073) 2 medium term Group - Bechdolf 2004

Subtotal (95% CI)

48

3.2 (1)

48

40

3.5 (0.9)

40

Heterogeneity: not applicable Test for overall effect: Z = 1.48 (P = 0.14) 3 long term Group - Bechdolf 2004

Subtotal (95% CI)

25

25

2.9 (1.1)

16

3.4 (0.7)

16

Heterogeneity: not applicable Test for overall effect: Z = 1.78 (P = 0.075)

-1

-0.5

Favours psychoeducation

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0

0.5

1

Favours CBT

105

Analysis 2.2. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 2 Relapse: Relapse for any reason (medium term)

Study or subgroup

Group - Bechdolf 2004

Brief Psychoeducation

CBT

n/N

n/N

10/48

5/40

Risk Ratio

Risk Ratio

M-H,Fixed,95% CI

M-H,Fixed,95% CI 1.67 [ 0.62, 4.48 ]

0.2

0.5

1

Favours psychoeducation

2

5

Favours CBT

Analysis 2.3. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 3 Service utilisation: hospitalisation (long term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 3 Service utilisation: hospitalisation (long term)

Study or subgroup

Group - Bechdolf 2004

Brief Psychoeducation

CBT

n/N

n/N

16/27

6/16

Risk Ratio

Risk Ratio

M-H,Fixed,95% CI

M-H,Fixed,95% CI 1.58 [ 0.78, 3.20 ]

0.02

0.1

Favours psychoeducation

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1

10

50

Favours CBT

106

Analysis 2.4. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 4 Mental state: Specific - average endpoint PANSS scores (high = poor). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 4 Mental state: Specific - average endpoint PANSS scores (high = poor)

Study or subgroup

Brief Psychoeducation

Mean Difference

CBT

Mean Difference

N

Mean(SD)

N

Mean(SD)

IV,Fixed,95% CI

IV,Fixed,95% CI

48

11.4 (4.5)

40

11.3 (4.2)

0.10 [ -1.72, 1.92 ]

48

13.1 (5.2)

40

13.9 (4.5)

-0.80 [ -2.83, 1.23 ]

48

25 (6.2)

40

28 (9.2)

-3.00 [ -6.35, 0.35 ]

48

11.4 (4.8)

40

11.6 (43)

-0.20 [ -13.59, 13.19 ]

48

13 (6.1)

40

12.5 (4)

0.50 [ -1.62, 2.62 ]

48

26 (6.9)

40

28.5 (8.8)

-2.50 [ -5.85, 0.85 ]

25

13.5 (6.6)

16

13.6 (5.6)

-0.10 [ -3.87, 3.67 ]

25

14.5 (6.3)

16

13.7 (5)

0.80 [ -2.68, 4.28 ]

25

26.4 (6.9)

16

28.1 (6.3)

-1.70 [ -5.80, 2.40 ]

1 short term - positive score Group - Bechdolf 2004 2 short term - negative score Group - Bechdolf 2004 3 short term - general score Group - Bechdolf 2004 4 medium term - positive score Group - Bechdolf 2004 5 medium term - negative score Group - Bechdolf 2004 6 medium term - general score Group - Bechdolf 2004 7 long term - positive score Group - Bechdolf 2004 8 long term - negative score Group - Bechdolf 2004 9 long term - general score Group - Bechdolf 2004

-10

-5

Favours psychoeducation

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5

10

Favours CBT

107

Analysis 2.5. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 5 Quality of life: Average endpoint MSQoL-54 score (high = good). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT Outcome: 5 Quality of life: Average endpoint MSQoL-54 score (high = good)

Study or subgroup

Brief Psychoeducation

Mean Difference

CBT

Mean Difference

N

Mean(SD)

N

Mean(SD)

IV,Fixed,95% CI

IV,Fixed,95% CI

35

54.6 (25.7)

28

52.8 (22.7)

1.80 [ -10.17, 13.77 ]

38

65.4 (24)

26

60.9 (21.2)

4.50 [ -6.66, 15.66 ]

1 short term Group - Bechdolf 2004 2 medium term Group - Bechdolf 2004

-20

-10

Favours psychoeducation

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10

20

Favours CBT

108

Analysis 3.1. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 1 Compliance: 1a. With medication - non-compliance

Brief Pyschoeducation

Routine care

n/N

n/N

Group - Dai 2007

3/51

7/51

70.0 %

0.43 [ 0.12, 1.57 ]

Group - Zhang 2006

2/30

3/30

30.0 %

0.67 [ 0.12, 3.71 ]

81

81

100.0 %

0.50 [ 0.18, 1.40 ]

24/143

36/143

100.0 %

0.67 [ 0.42, 1.06 ]

143

143

100.0 %

0.67 [ 0.42, 1.06 ]

3/59

18/59

100.0 %

0.17 [ 0.05, 0.54 ]

59

59

100.0 %

0.17 [ 0.05, 0.54 ]

Study or subgroup

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 group - short term

Subtotal (95% CI)

Total events: 5 (Brief Pyschoeducation), 10 (Routine care) Heterogeneity: Chi2 = 0.16, df = 1 (P = 0.69); I2 =0.0% Test for overall effect: Z = 1.32 (P = 0.19) 2 unclear - short term Unclear - Li 2005

Subtotal (95% CI)

Total events: 24 (Brief Pyschoeducation), 36 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.72 (P = 0.085) 3 both - medium term Both - Liu 2004

Subtotal (95% CI)

Total events: 3 (Brief Pyschoeducation), 18 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 3.01 (P = 0.0026)

0.02

0.1

Favours group brief pyschoeducation

1

10

50

Favours routine care

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Analysis 3.2. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With follow up - loss to follow-up for any reason. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 2 Compliance: 1b. With follow up - loss to follow-up for any reason

Study or subgroup

Brief Pyschoeducation

Routine care

n/N

n/N

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 both - short term - loss to follow-up for any reason Both - Tom 1989

3/15

3/15

100.0 %

1.00 [ 0.24, 4.18 ]

15

15

100.0 %

1.00 [ 0.24, 4.18 ]

4/17

1/21

2.6 %

4.94 [ 0.61, 40.19 ]

Group - Hornung 1995

15/67

22/57

69.8 %

0.58 [ 0.33, 1.01 ]

Group - Merinder 1999

6/24

9/22

27.6 %

0.61 [ 0.26, 1.44 ]

108

100

100.0 %

0.70 [ 0.45, 1.09 ]

9/61

9/53

100.0 %

0.87 [ 0.37, 2.03 ]

61

53

100.0 %

0.87 [ 0.37, 2.03 ]

6/75

9/75

22.7 %

0.67 [ 0.25, 1.78 ]

44/125

29/111

77.3 %

1.35 [ 0.91, 2.00 ]

200

186

100.0 %

1.19 [ 0.83, 1.72 ]

19/67

23/57

100.0 %

0.70 [ 0.43, 1.15 ]

67

57

100.0 %

0.70 [ 0.43, 1.15 ]

Subtotal (95% CI)

Total events: 3 (Brief Pyschoeducation), 3 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.0 (P = 1.0) 2 group - medium term - loss to follow-up for any reason Group - Coyle 1988

Subtotal (95% CI)

Total events: 25 (Brief Pyschoeducation), 32 (Routine care) Heterogeneity: Chi2 = 3.89, df = 2 (P = 0.14); I2 =49% Test for overall effect: Z = 1.57 (P = 0.12) 3 individual - medium term - loss to follow-up for any reason Individual - Cunningham 2001

Subtotal (95% CI)

Total events: 9 (Brief Pyschoeducation), 9 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.33 (P = 0.75) 4 group - long term - loss to follow-up for any reason (by 1 year) Group - Aguglia 2007 Group - Bauml 2007

Subtotal (95% CI)

Total events: 50 (Brief Pyschoeducation), 38 (Routine care) Heterogeneity: Chi2 = 1.72, df = 1 (P = 0.19); I2 =42% Test for overall effect: Z = 0.95 (P = 0.34) 5 group - long term - loss to follow-up for any reason (by 2 years) Group - Hornung 1995

Subtotal (95% CI)

Total events: 19 (Brief Pyschoeducation), 23 (Routine care)

0.001 0.01 0.1

1

Favours group brief pyschoeducation

10 100 1000 Favours routine care

(Continued . . . )

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(. . . Study or subgroup

Brief Pyschoeducation

Routine care

n/N

n/N

Risk Ratio

Weight

M-H,Fixed,95% CI

Continued) Risk Ratio

M-H,Fixed,95% CI

Heterogeneity: not applicable Test for overall effect: Z = 1.40 (P = 0.16) 6 group - long term - loss to follow-up for any reason (by 5 years or more) Group - Hornung 1995

Subtotal (95% CI)

19/67

22/57

100.0 %

0.73 [ 0.44, 1.21 ]

67

57

100.0 %

0.73 [ 0.44, 1.21 ]

Total events: 19 (Brief Pyschoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.20 (P = 0.23)

0.001 0.01 0.1

1

Favours group brief pyschoeducation

10 100 1000 Favours routine care

Analysis 3.3. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 3 Relapse: 1. Relapse for any reason. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 3 Relapse: 1. Relapse for any reason

Brief Pyschoeducation

Routine care

n/N

n/N

6/44

8/37

18.1 %

0.63 [ 0.24, 1.65 ]

Group - Merinder 1999

14/24

15/22

32.6 %

0.86 [ 0.55, 1.33 ]

Group - Razali 1995

11/85

23/80

49.3 %

0.45 [ 0.23, 0.86 ]

Subtotal (95% CI)

153

139

100.0 %

0.61 [ 0.43, 0.89 ]

22/53

100.0 %

0.87 [ 0.55, 1.38 ]

Study or subgroup

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 group - medium term Group - Chan 2007

Total events: 31 (Brief Pyschoeducation), 46 (Routine care) Heterogeneity: Chi2 = 3.03, df = 2 (P = 0.22); I2 =34% Test for overall effect: Z = 2.59 (P = 0.0096) 2 individual - medium term Individual - Cunningham 2001

22/61

0.2

0.5

1

Favours group brief pyschoeducation

2

5

Favours routine care

(Continued . . . )

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(. . . Study or subgroup

Continued)

Brief Pyschoeducation

Routine care

n/N

n/N

61

53

100.0 %

0.87 [ 0.55, 1.38 ]

30/67

30/57

100.0 %

0.85 [ 0.59, 1.22 ]

67

57

100.0 %

0.85 [ 0.59, 1.22 ]

48/67

46/57

100.0 %

0.89 [ 0.73, 1.08 ]

67

57

100.0 %

0.89 [ 0.73, 1.08 ]

Subtotal (95% CI)

Risk Ratio

Weight

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

Total events: 22 (Brief Pyschoeducation), 22 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.60 (P = 0.55) 3 group - long term Group - Hornung 1995

Subtotal (95% CI)

Total events: 30 (Brief Pyschoeducation), 30 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.87 (P = 0.38) 4 group - long term (at 5 years follow-up) Group - Hornung 1995

Subtotal (95% CI)

Total events: 48 (Brief Pyschoeducation), 46 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 1.18 (P = 0.24)

0.2

0.5

1

Favours group brief pyschoeducation

2

5

Favours routine care

Analysis 4.1. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Relapse: Relapse for any reason (medium term). Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT Outcome: 1 Relapse: Relapse for any reason (medium term)

Study or subgroup

Group - Bechdolf 2004

Brief Psychoeducation

CBT

n/N

n/N

10/48

5/40

Risk Ratio

Risk Ratio

M-H,Fixed,95% CI

M-H,Fixed,95% CI 1.67 [ 0.62, 4.48 ]

0.2

0.5

Favours psychoeducation

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2

5

Favours CBT

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Analysis 4.2. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term)-without assumption. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT Outcome: 2 Relapse: Relapse for any reason (medium term)-without assumption

Study or subgroup

Brief Psychoeducation

CBT

n/N

n/N

8/40

4/31

Group - Bechdolf 2004

Risk Ratio

Risk Ratio

M-H,Fixed,95% CI

M-H,Fixed,95% CI 1.55 [ 0.51, 4.68 ]

0.2

0.5

1

Favours psychoeducation

2

5

Favours CBT

Analysis 5.1. Comparison 5 SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance. Review:

Psychoeducation (brief) for people with serious mental illness

Comparison: 5 SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION Outcome: 1 Compliance: 1a. With medication - non-compliance

Study or subgroup

Psychoeducation

Routine care

n/N

n/N

Risk Ratio

Weight

Group - Dai 2007

3/51

7/51

15.2 %

0.43 [ 0.12, 1.57 ]

Group - Zhang 2006

2/30

3/30

6.5 %

0.67 [ 0.12, 3.71 ]

24/143

36/143

78.3 %

0.67 [ 0.42, 1.06 ]

224

224

100.0 %

0.63 [ 0.41, 0.96 ]

2/30

3/30

100.0 %

0.67 [ 0.12, 3.71 ]

30

30

100.0 %

0.67 [ 0.12, 3.71 ]

M-H,Fixed,95% CI

Risk Ratio M-H,Fixed,95% CI

1 short term - with high risk trials

Unclear - Li 2005

Subtotal (95% CI)

Total events: 29 (Psychoeducation), 46 (Routine care) Heterogeneity: Chi2 = 0.40, df = 2 (P = 0.82); I2 =0.0% Test for overall effect: Z = 2.15 (P = 0.032) 2 short term - without high risk trials Group - Zhang 2006

Subtotal (95% CI)

Total events: 2 (Psychoeducation), 3 (Routine care) Heterogeneity: not applicable Test for overall effect: Z = 0.46 (P = 0.64)

0.002

0.1

Favours psychoeducation

1

10

500

Favours routine care

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ADDITIONAL TABLES Table 1. Suggested design of study

Methods

Allocation: randomised, fully explicit description of methods of randomisation and allocation concealment. Blinding: single, tested. Setting: community rather than hospital. Duration: 12 weeks treatment, and then follow-up to at least 52 weeks

Participants

Diagnosis: schizophrenia (ICD). n = 300.* Age: adults. Sex: both.

Interventions

1. Brief Psychoeducation: didactic interventions of psychoeducation or patient-teaching involving individuals or groups; programmes of 10 sessions or less will be considered as ’brief ’. n = 150 2. Standard care. n = 150.

Outcomes

General: time to all-cause treatment failure marked by its discontinuation, relapse, general impression of clinician (CGI), career/other, compliance with treatment, healthy days. Mental state: BPRS and PANSS. Global state: CGI (Clinical Global Impression). Quality of life. QOL (Quality of Life Questionnaire). Family burden: FBQ (Family Burden Questionnaire). Social functioning: return to everyday living for 80% of time.* Adverse events: any adverse event recorded. Economic outcomes.

Notes

* Powered to be able to identify a difference of ~ 20% between groups for primary outcome with adequate degree of certainty

BPRS = Brief Psychiatric Rating Scale ICD = International Classification of Diseases PANSS = Positive and Negative Syndrome Scale

Table 2. Reviews suggested by excluded studies

Broad category of com- Intervention parison

Control

Psychoeducation for car- 10 weekly psychoeduca- Routine care ers or family members tion based on the routine care

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Excluded study/studies Existing Cochrane reviews Cheng 2005

-

114

Table 2. Reviews suggested by excluded studies

(Continued)

Psychoeducation family Routine care intervention Psychoeducation

Non specific group for O’Callaghan 2009 carers or treatment as usual

Standard length Supportive therapy psychoeducation (10 sessions)

Shin 2002

Psychoeducaitonal Drug treatment only family intervention plus drug therapy

Ying 2006

Drug Drug treatment only treatment plus psychoeducational family intervention versus; however, only family members of received the psycho education;

Xiang 1994

Psychoeducational sup- Wait-list group port-group

Posner 1992

Drug treatment plus psychoeducational family intervention; patients relatives were taught the basic knowledge of mental disease, treatment, etc

Psychoeducation 10 sessions)

Magliano 2004

Control group 1:drug Ran 2003 treatment only Control group 2:no interventions which means medications were not neither encouraged or discouraged

(over 24 sessions of informa- 24 sessions of informa- Carra 2010 tive programme tive programme plus 48 sessions of supportive group programme

Psychoeducation for schizophrenia

21 sessions of psychoed- 21 sessions Chabannes 2009 ucational programme of programme delivering usual information on the disease Not pure psychoeduca- 24-week psychoedtion ucation programme contains elements of interpersonal skills training

Contol group 1: 24- Chien 2013 week mutual support group Control group 2: standard care

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-

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Table 2. Reviews suggested by excluded studies

(Continued)

Psychoeducative coping Supportive Fries 2003 oriented therapy discussion and problemsolving training ’Decision aid’ interven- Routine care tion: this intervention provides information about the illness, but it lacks of core elements of psychoeducation

Other therapy

Hamann 2006

Assertive community treatment combined with psychoeducational multifamily treatment group; psychoeducation is given only as one element of a care package, which includes other elements such as skills training and family support

AsMcFarlane 1995 sertive community treatment combined with crisis family intervention

CognitiveTraining

Occupational Therapy

Pitschel-Walz 2013

Cognitive training and cognitive rehabilitation for mild to moderate Alzheimer’s disease and vascular dementia

Coping oriented therapy No details about the con- Pfammatter 1999 trol group

-

Telehealth

Rotondi 2005

-

Sibitz 2007

-

Usual care

Booster sessions (of psy- No booster sessions choeducation)

CONTRIBUTIONS OF AUTHORS SZ - protocol development, data screening and extraction, data entry and analysis. JX - protocol development, data screening and extraction. SS - data extraction, data analysis and report writing. MBJ - protocol development.

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DECLARATIONS OF INTEREST All authors have no known conflict of interest, however JX received a grant from the Cochrane Schizophrenia Group to complete this protocol.

SOURCES OF SUPPORT Internal sources • Cochrane Schizophrenia Group, UK. Provided grant to lead author to help complete this protocol

External sources • Cochrane Collaboration Programme Grant 2011, UK.

DIFFERENCES BETWEEN PROTOCOL AND REVIEW None.

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Psychoeducation (brief) for people with serious mental illness.

Those with serious/severe mental illness, especially schizophrenia and schizophrenic-like disorders, often have little to no insight regarding the pre...
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