BRIEF REPORT
Therapist Adherence in the Strong Without Anorexia Nervosa (SWAN) Study: A Randomized Controlled Trial of Three Treatments for Adults with Anorexia Nervosa Louise J. Andony, DPsych (Clin)1,2* Elaine Tay, DPsych (Clin)1 Karina L. Allen, PhD, MPsych (Clin)1 Tracey D. Wade, PhD, MPsych (Clin)3 Phillipa Hay, MD, PhD4 Stephen Touyz, PhD5 Virginia V.W. McIntosh, PhD, Dip Clin Psyc6 Janet Treasure, MD, PhD, FRCP, FRCPsych7 Ulrike H. Schmidt, MD, PhD7 Christopher G. Fairburn, FMedSci8 David M. Erceg-Hurn, BPsych (Hons)2 Anthea Fursland, PhD, MPsych (Clin)2 Ross D. Crosby, PhD9 Susan M. Byrne, PhD, Dphil1,2
ABSTRACT Objective: To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). Method: The SWAN Psychotherapy Rating Scale (SWAN-PRS) was developed, after consultation with the developers of the treatments, and refined. Using the SWANPRS, two independent raters initially rated 48 audiotapes of treatment sessions to yield inter-rater reliability data. One rater proceeded to rate a total of 98 audiotapes from 64 trial participants.
was considered a reliable measure of therapist adherence. The three treatments were highly distinguishable by independent raters, with therapists demonstrating significantly more behaviors consistent with the actual allocated treatment compared to the other two treatment modalities. There were no significant site differences in therapist adherence observed. Discussion: The findings provide support for the internal validity of the SWAN study. The SWAN-PRS was deemed suitable for use in other trials involving CBT-E, C 2015 The Authors. MANTRA, or SSCM. V International Journal of Eating Disorders Published by Wiley Periodicals, Inc. Keywords: therapist adherence; anorexia nervosa; CBT-E; MANTRA; SSCM; randomized controlled trial (Int J Eat Disord 2015; 48:1170–1175)
Results: The SWAN-PRS demonstrated sound psychometric properties, and
Accepted 11 August 2015 Supported by 634434 from National Health and Medical Research Council, by McCusker Foundation, and by 046386 from Wellcome Principal Research Fellowship. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. *Correspondence to: Louise Julia Andony, School of Psychology, University of Western Australia, Perth, Western Australia. E-mail: [email protected] 1 School of Psychology, University of Western Australia, Perth, Western Australia 2 Centre for Clinical Interventions, Perth, Western Australia 3 School of Psychology, Flinders University, Adelaide, South Australia 4 School of Medicine, University of Western Sydney, Sydney, New South Wales 5 School of Psychology, University of Sydney, Sydney, New South Wales 6 Department of Psychological Medicine, University of Otago, Dunedin, New Zealand 7 Psychological Medicine, King’s College London, London, United Kingdom 8 Department of Psychiatry, University of Oxford, Oxford, United Kingdom 9 Neuropsychiatric Research Institute, Fargo, North Dakota Published online 28 October 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/eat.22455 C 2015 The Authors. International Journal of Eating Disorders V Published by Wiley Periodicals, Inc.
In clinical trials, measuring the extent to which therapists implement treatments in accordance with their respective protocols is essential, in order for conclusions regarding treatment efficacy to be confidently determined.1,2 Assessing therapist adherence also provides an indication whether treatments under investigation can be differentiated.2,3 Therapist adherence is commonly measured by reviewing recordings of therapy sessions, and rating whether core treatment components are observed using a suitable rating scale. These rating scales also tend to include items that measure nonspecific factors, such as therapist empathy.1,4,5 A well-known adherence scale is the Collaborative Study Psychotherapy Rating Scale (CSPRS), which was designed to assess whether therapists involved in the National Institute of Mental Health Treatment of Depression Collaborative Research Program adhered to the four treatments being compared (Unpublished manuscript).6,7
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International Journal of Eating Disorders 48:8 1170–1175 2015
Introduction
THERAPIST ADHERENCE
Because there are no “gold standard” treatments for adults with anorexia nervosa (AN), it is particularly important to ensure treatments involved in randomized clinical trials (RCT) are implemented in line with their specifications. Only one study has examined therapist adherence in a RCT of treatments for AN.8,9 McIntosh et al.9 used a modified version of the CSPRS (CSPRS-AN) to investigate adherence to, and differentiation between Cognitive Behavioural Therapy, Interpersonal Psychotherapy and Specialist Supportive Clinical management (SSCM). Results indicated that the 90-item CSPRS-AN was able to differentiate treatments reliably, and no differences in therapist adherence were found. The current study examined therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center RCT comparing three different psychological treatments for adults with AN10: Enhanced Cognitive Behavioural Therapy (CBTE)11; Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA)12,13; and SSCM.14 The aims were to (1) develop and test a measure of therapist adherence for use in the SWAN study, (2) assess therapist adherence to the treatments under investigation, and (3) examine inter-site differences in therapist adherence.
Method Participants Participants in the SWAN study were 120 individuals (97.5% female) recruited at three Australian sites: Perth (n 5 80); Adelaide (n 5 21), and Sydney (n 5 19). Participants in the current study were 64 females drawn from this broader participant pool (Age: M 5 26.72, SD 5 10.21). Ethics approval was obtained and all participants provided informed consent. Inclusion criteria for the SWAN study were: body mass index (BMI) 14.0 and 18.5; aged 17 years and over; and meeting diagnostic criteria A and B for AN in DSM-IV-TR.15 Exclusion criteria were severe medical or suicidal risk, inability to complete full treatment course, and current use of olanzapine or other active psychotherapy. Participants were randomized to one of the three treatments. Number of treatment sessions allocated was titrated according to BMI (40 sessions for BMI:
Therapist Adherence in the Strong Without Anorexia Nervosa (SWAN) Study: A Randomized Controlled Trial of Three Treatments for Adults with Anorexia Nervosa Louise J. Andony, DPsych (Clin)1,2* Elaine Tay, DPsych (Clin)1 Karina L. Allen, PhD, MPsych (Clin)1 Tracey D. Wade, PhD, MPsych (Clin)3 Phillipa Hay, MD, PhD4 Stephen Touyz, PhD5 Virginia V.W. McIntosh, PhD, Dip Clin Psyc6 Janet Treasure, MD, PhD, FRCP, FRCPsych7 Ulrike H. Schmidt, MD, PhD7 Christopher G. Fairburn, FMedSci8 David M. Erceg-Hurn, BPsych (Hons)2 Anthea Fursland, PhD, MPsych (Clin)2 Ross D. Crosby, PhD9 Susan M. Byrne, PhD, Dphil1,2
ABSTRACT Objective: To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). Method: The SWAN Psychotherapy Rating Scale (SWAN-PRS) was developed, after consultation with the developers of the treatments, and refined. Using the SWANPRS, two independent raters initially rated 48 audiotapes of treatment sessions to yield inter-rater reliability data. One rater proceeded to rate a total of 98 audiotapes from 64 trial participants.
was considered a reliable measure of therapist adherence. The three treatments were highly distinguishable by independent raters, with therapists demonstrating significantly more behaviors consistent with the actual allocated treatment compared to the other two treatment modalities. There were no significant site differences in therapist adherence observed. Discussion: The findings provide support for the internal validity of the SWAN study. The SWAN-PRS was deemed suitable for use in other trials involving CBT-E, C 2015 The Authors. MANTRA, or SSCM. V International Journal of Eating Disorders Published by Wiley Periodicals, Inc. Keywords: therapist adherence; anorexia nervosa; CBT-E; MANTRA; SSCM; randomized controlled trial (Int J Eat Disord 2015; 48:1170–1175)
Results: The SWAN-PRS demonstrated sound psychometric properties, and
Accepted 11 August 2015 Supported by 634434 from National Health and Medical Research Council, by McCusker Foundation, and by 046386 from Wellcome Principal Research Fellowship. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. *Correspondence to: Louise Julia Andony, School of Psychology, University of Western Australia, Perth, Western Australia. E-mail: [email protected] 1 School of Psychology, University of Western Australia, Perth, Western Australia 2 Centre for Clinical Interventions, Perth, Western Australia 3 School of Psychology, Flinders University, Adelaide, South Australia 4 School of Medicine, University of Western Sydney, Sydney, New South Wales 5 School of Psychology, University of Sydney, Sydney, New South Wales 6 Department of Psychological Medicine, University of Otago, Dunedin, New Zealand 7 Psychological Medicine, King’s College London, London, United Kingdom 8 Department of Psychiatry, University of Oxford, Oxford, United Kingdom 9 Neuropsychiatric Research Institute, Fargo, North Dakota Published online 28 October 2015 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/eat.22455 C 2015 The Authors. International Journal of Eating Disorders V Published by Wiley Periodicals, Inc.
In clinical trials, measuring the extent to which therapists implement treatments in accordance with their respective protocols is essential, in order for conclusions regarding treatment efficacy to be confidently determined.1,2 Assessing therapist adherence also provides an indication whether treatments under investigation can be differentiated.2,3 Therapist adherence is commonly measured by reviewing recordings of therapy sessions, and rating whether core treatment components are observed using a suitable rating scale. These rating scales also tend to include items that measure nonspecific factors, such as therapist empathy.1,4,5 A well-known adherence scale is the Collaborative Study Psychotherapy Rating Scale (CSPRS), which was designed to assess whether therapists involved in the National Institute of Mental Health Treatment of Depression Collaborative Research Program adhered to the four treatments being compared (Unpublished manuscript).6,7
1170
International Journal of Eating Disorders 48:8 1170–1175 2015
Introduction
THERAPIST ADHERENCE
Because there are no “gold standard” treatments for adults with anorexia nervosa (AN), it is particularly important to ensure treatments involved in randomized clinical trials (RCT) are implemented in line with their specifications. Only one study has examined therapist adherence in a RCT of treatments for AN.8,9 McIntosh et al.9 used a modified version of the CSPRS (CSPRS-AN) to investigate adherence to, and differentiation between Cognitive Behavioural Therapy, Interpersonal Psychotherapy and Specialist Supportive Clinical management (SSCM). Results indicated that the 90-item CSPRS-AN was able to differentiate treatments reliably, and no differences in therapist adherence were found. The current study examined therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center RCT comparing three different psychological treatments for adults with AN10: Enhanced Cognitive Behavioural Therapy (CBTE)11; Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA)12,13; and SSCM.14 The aims were to (1) develop and test a measure of therapist adherence for use in the SWAN study, (2) assess therapist adherence to the treatments under investigation, and (3) examine inter-site differences in therapist adherence.
Method Participants Participants in the SWAN study were 120 individuals (97.5% female) recruited at three Australian sites: Perth (n 5 80); Adelaide (n 5 21), and Sydney (n 5 19). Participants in the current study were 64 females drawn from this broader participant pool (Age: M 5 26.72, SD 5 10.21). Ethics approval was obtained and all participants provided informed consent. Inclusion criteria for the SWAN study were: body mass index (BMI) 14.0 and 18.5; aged 17 years and over; and meeting diagnostic criteria A and B for AN in DSM-IV-TR.15 Exclusion criteria were severe medical or suicidal risk, inability to complete full treatment course, and current use of olanzapine or other active psychotherapy. Participants were randomized to one of the three treatments. Number of treatment sessions allocated was titrated according to BMI (40 sessions for BMI:
