SPECIAL TOPICS SERIES
Individualized Guided Internet-delivered Cognitive-Behavior Therapy for Chronic Pain Patients With Comorbid Depression and Anxiety A Randomized Controlled Trial Monica Buhrman, PhD,* Martin Syk, MSc,* Olle Burvall, MSc,* Terry Hartig, PhD,* Torsten Gordh, MD, PhD,w and Gerhard Andersson, PhDzy
Objectives: Depression and anxiety are commonly seen in patients with chronic pain which affects the patient’s daily life functioning. Although considerable attention has been devoted to explain why depression and anxiety are frequent comorbid with chronic pain, little empirical work has been conducted on interventions that target depression and anxiety and chronic pain. The present study was designed to test an individualized cognitive-behavioral treatment delivered through the internet for persons with chronic pain and emotional distress. Materials and Methods: A total of 52 patients with chronic pain and depression were included and randomized to either treatment for 8 weeks or to a control group that participated in a moderated online discussion forum. Results: Intent-to-treat analyses showed significant decreases regarding depressive symptoms and pain disability in the treatment group. Results on the primary outcomes of depression and anxiety were in favor of the treatment group. Reductions were also found on pain catastrophizing. Discussion: One-year follow-up showed maintenance of improvements. We conclude that an individualized guided internet-delivered treatment based on cognitive-behavior therapy can be effective for persons with chronic pain comorbid emotional distress. Key Words: individualized treatment, internet-delivered CBT, chronic pain, depression, anxiety, disability, CBT, guided self-help
(Clin J Pain 2015;31:504–516)
C
hronic pain often has adverse effects on daily activity, employment, relationships, and emotional functioning.1 The costs related to chronic pain in Europe and the United States is estimated at 14% of the country’s gross domestic product.2 People with chronic pain often experience high levels of disability3 in various life domains.4,5 Furthermore, chronic pain has been found to be associated Received for publication July 15, 2014; revised November 26, 2014; accepted October 22, 2014. From the *Department of Psychology; wPain Research, Department of Surgical Sciences, Uppsala University; zDepartment of Behavioural Sciences and Learning, Linko¨ping University, Linko¨ping University; and yPsychiatry Section, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. The authors declare no conflict of interest. Reprints: Monica Buhrman, PhD, Department of Psychology, Box 1225, 754 41 Uppsala, Sweden (e-mail: monica.buhrman@psyk. uu.se). Copyright r 2014 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/AJP.0000000000000176
504 | www.clinicalpain.com
with mood and anxiety disorders but also with somatoform, substance use, and personality disorders.6 The prevalence of major depressive disorder in chronic pain patients has been reported to range between 30% and 54%.4,6 Depression has been found to be associated with poor painrelated outcomes such as functional limitations.7 Moreover, persons with chronic pain and depression report greater disability and interference with daily activities.4 Depression has also been reported to be a predictor for the onset of disabling pain.8–10 The association between pain and depression has been found to be complicated in part because of the multidimensional nature of pain, with both sensory and affective dimensions.4 Pain intensity does not always correlate with depressed mood in chronic pain patients.11 Several factors seem to influence the paindepression relationship.12 For example, a longitudinal study showed that self-criticism in female patients contributed to the experience of subsequent depressive symptoms.13 Anxiety has also been documented to coexist with chronic pain.6 When overlooked, the comorbidity between pain and anxiety may reduce response to treatment.14 Furthermore, anxiety has been shown to be related to the experience and adjustment to pain.8,15 Thus, both depression and anxiety can be regarded as important targets for intervention in association with chronic pain. There is substantial body of research indicating the efficacy of cognitive-behavioral treatments (CBT) for chronic pain.16–18 However, for many people with chronic pain, CBT is not available. Other barriers such as geographic and economic circumstances can hinder individuals with chronic pain to obtain evidence-based treatments.12,19 Internet-based CBT (iCBT) is rapidly evolving as a means for overcoming many of the mentioned barriers.20 Several disorders have been studied with iCBT and results have been equivalent with face-to-face therapies,21 for example, panic disorder,22–24 social anxiety disorder,25,26 and depression.27,28 iCBT have been shown to be effective for depression and anxiety and a range of other disorders.29,30 Several reviews have reported the effects of iCBT for the treatment of chronic pain.31–33 iCBT can be guided by a clinician, where technology is used in conjunction with therapist contact to support the patient.30 The internet programs vary in length between 6 and 20 weeks and intervention often include a secure contact portal where the therapist and the patient can communicate. The support offered involves providing feedback on weekly reports, reminders to complete program activities. Outcomes include pain intensity, function level; and psychosocial Clin J Pain
Volume 31, Number 6, June 2015
Clin J Pain
Volume 31, Number 6, June 2015
measures; that is, depression and anxiety.31 In contrast, unguided iCBT is fully automated, and there are examples of unguided iCBT programs for chronic pain showing promising results.34,35 In 1 study 141 participants with chronic low back pain were randomly assigned to either a 3week iCBT intervention or a waitlist. The intervention contained information about pain, relaxation exercises, and cognitive and behavioral strategies to cope with pain. Treatment was unguided but participants were reminded to log in if they did not do so at least once per week. Results showed positive effects on pain-related outcomes such as disability, self-efficacy, fearful avoidance of physical activity, and pain catastrophizing.34 Results have shown that iCBT is associated with improvements in pain, activity limitation, and costs associated with treatment. The effects on depression and anxiety are, however, less consistent.31,32 A recent study36 showed that a clinician-guided iCBT program reduced disability, anxiety, and depression associated with chronic pain with moderate to large effect sizes. In the study, 63 adults with different diagnoses of chronic pain were randomized to either a treatment group or a waitlist control group. The treatment group received a CBT-based intervention during 8 weeks. The program content was based on the principles of CBT for anxiety and depression. A clinical psychologist provided weekly feedback through secure e-mail and telephone. Positive results were found on the different outcomes measuring disability, anxiety, depression, and average pain.36 In addition to the benefits of being accessible and cost-effective, iCBT can meet patients at different phases. For example, iCBT opens up the possibility to individualize the treatment for the patient. A study comparing individualized iCBT to standardized iCBT for depression and comorbid symptoms found that tailored iCBT was more effective for individuals with higher levels of depression and more comorbidity,37 and other studies on comorbid anxiety and depression show promising findings.38–40 Thus, given the comorbidity between chronic pain, depression, and anxiety, tailored iCBT could be a useful approach for this patient group.41 The purpose of the present study was to investigate if a guided individualized iCBT intervention could help persons with chronic pain with depression and anxiety. Participants were recruited from a clinical setting and advertisement. The active treatment group was compared with a moderated online discussion forum which has been used as an active intervention in previous studies.42 As CBT is effective for depression and anxiety and chronic pain treatment, it is possible to incorporate elements of CBT for depression, anxiety disorders, and chronic pain.14 An important component of the treatment program in the present study consisted of behavioral activation which has been shown effective for depression43,44 but also in the context of comorbid conditions such as obesity45 and chronic pain.46,47 There is also research showing that CBT can be effective for anxiety and comorbid chronic pain.47 Furthermore, in the present treatment package there was a possibility to include CBT for insomnia which has been shown to work for insomnia and comorbid chronic pain.48,49 Mindfulness was also a possible component in the treatment program. Research shows that mindfulness can improve depression and anxiety in patients with chronic pain (see meta-analysis50). Thus, tailoring iCBT for chronic pain may be a way to target comorbid problems that are not targeted in regular iCBT programs for chronic pain. The aim of this study was to conduct a randomized Copyright
r
Individualized Guided iCBT for Chronic Pain Patients
controlled trial to test this. Our hypothesis was that the treatment group would report significant improvements on measures of disability, depression, anxiety, catastrophizing, and quality of life.
METHODS Recruitment Procedure and Inclusion Participants were recruited from the Pain Centre at the Uppsala University hospital in Sweden and through an advertisement in a newspaper. Patients who had visited the Pain Centre the last year (n = 200) were contacted by telephone to receive information about the study. Interested individuals were asked to visit a Web site (http://www. studie.nu) where they could read more about the study and report their interest to participate. Individuals were asked to register an e-mail address. Information about how to register to access to the screening procedure were given. Inclusion criteria required that participants had undergone previous medical investigation(s) (within 1 y) to avoid participants with undiagnosed chronic pain disorders who needed further medical investigations, had chronic pain (ie, pain for >3 mo), had regular access to the internet, and had problem with depression and anxiety defined in the present study a total score of >10 points on the Montgomery A˚sberg Depression Rating Scale (MADRS-S) was defined as a depressive state51 and present psychological distress assessed in the structured telephone interview with Primary Care Evaluation of Mental Disorders (PRIMEMD). Exclusion criteria consisted of patients with ongoing medical investigations because that would intervene with the persons’ participation in the present trial, diagnosed dysthymia (as the present treatment did not focus on that kind of problem), ongoing treatment that could interfere with participation in the study, such as planned surgery and acute physical or psychiatric conditions that requires immediate treatment, for example, schizophrenia, dissociative disorder. In addition, participants had to be fluent in the Swedish language. The screening consisted of different forms and questions to see if the individual fulfilled the inclusion or exclusion criteria. The screening forms were presented on a secure web platform that required double authentication. Here the individuals were also asked to fill in an informed consent and they were informed about the security of the platform and that that they could interrupt participation in the study whenever they wanted. If the person had not filled in the screening questions a reminder was sent. After the participant had completed the online screening (including demographic questions such as perceived discomfort level, pain intensity, pain duration, previous contact with the health care system, psychiatric, and other somatic disorders) and pretreatment measures he or she was contacted by telephone for a structured interview that lasted approximately for 30 minutes. The clinical structure interview was based on the PRIME-MD, which is a diagnostic manual based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.52 PRIME-MD is used to screen for depression, anxiety disorders, alcohol abuse, somatoform diagnosis, and eating disorders.53 During the screening interview information about the study was also given. A total of 68 individuals registered their interest on the study on the Web site and 60 filled out the screening questions and measures. Of these, 57 persons went through
2014 Wolters Kluwer Health, Inc. All rights reserved.
www.clinicalpain.com |
505
Clin J Pain
Buhrman et al
the telephone interview. After the telephone interview, 52 individuals remained and were randomized to either the treatment (n = 28) or to the control group (n = 24). For more detailed information see Figure 1. Randomization was made by an independent person using a true random number service (http://www.randomizer.org). Participants
Volume 31, Number 6, June 2015
were informed about which group they had been randomly assigned to. Before randomization participants were informed that they would be randomized to either group 1 (the treatment group) or group 2 (the control condition). Group 1 was described as an internet-based treatment for depression for persons with chronic pain based on CBT
Inquiry by telephone, Pain Center (n=) and advertisement in local
Registered on the web interest to participate
(n=68)
Excluded (n=8) Did not activate registration code n=2 Did not complete inclusion forms n=6
Assessed for eligibility
total (n=60)
Excluded (n=3) Could not be reached: n=2 Did not fulfilled the inclusion criteria regarding MADRS-S, n=1
Telephone interview (n=59)
Meeting exclusion criteria (n=2)
Excluded (n=2) Declined participation: n=2
Completed inclusion forms and telephone interview
Suffered from acute psychiatric disorder: n=2
(n=57)
Not meeting inclusion criteria (n=1) Score 30 y 3 (6) Sex (n [%]) Men 8 (15) Women 44 (85) Education level (n [%]) Nine-year compulsory school 10 (19) Upper secondary school 12 (23) University education 2 y 27 (52) Work status (n [%]) Sick leave 9 (17) Works 17 (33) Unemployed 14 (27) Pensioner 14 (27) Other* 4 (8) Pain location (n [%])w Back 63 (33) Neck 52 (27) Shoulders 54 (28) Generalized pain 46 (24) Mental disorders according to the PRIME-MD (n [%]) Mild depression 6 (12) Major depression 31 (60) Depression partial remission 2 (4) Generalized anxiety disorder 0 (0) Social anxiety 8 (15) Panic disorder 4 (8) Obsessive compulsive disorder 8 (4) Anxiety unspecified 24 (46)
3 1 3 5 9 6 1
(11) (4) (11) (18) (32) (21) (4)
3 2 5 2 6 4 2
(13) (8) (21) (8) (25) (17) (8)
1 0 1 1 1 5
(11) (0) (11) (11) (11) (56)
4 (14) 24 (86)
4 (17) 20 (83)
1 (11) 8 (89)
6 5 3 14
(21) (18) (11) (50)
4 7 0 13
(17) (29) (0) (54)
2 2 1 4
(22) (22) (11) (44)
4 7 6 9 2
(14) (25) (21) (38) (8)
5 10 2 5 2
(21) (42) (8) (21) (8)
0 4 1 1 3
(0) (44) (11) (11) (33)
46 46 50 46
(13) (13) (14) (13)
83 58 42 46
(20) (14) (10) (11)
11 44 22 22
(1) (4) (2) (2)
4 20 2 2 5 3 4 12
(14) (71) (7) (7) (18) (11) (14) (43)
2 11 0 1 3 1 0 12
(8) (46) (0) (4) (13) (4) (0) (50)
1 2 0 0 1 1 1 3
(11) (22) (0) (0) (11) (11) (11) (33)
*For example, parental leave. wParticipants could choose several locations. PRIME-MD indicates Primary Care Evaluation of Mental Disorders.
Copyright
r
2014 Wolters Kluwer Health, Inc. All rights reserved.
www.clinicalpain.com |
507
Clin J Pain
Buhrman et al
week. Participants were asked to send in their assignments every week to their therapist. To receive access to the next part of the treatment, participants had to send in their weekly assignments before a specified date. The therapist gave feedback to the participants regarding their exercises within 24 hours of receipt during weekdays. The feedback given to the participants was mostly positive reinforcement and replies to the participant’s inquiries. A reminder was sent through the platform to participants who did not complete their assignments, that is, they received a text message that informed them they had a message on the Web site and prompted them to log in, if the person did not reply to 2 e-mails the participants was contacted by telephone. After 4 weeks of treatment, participants in the treatment group were telephoned for an assessment regarding technical aspects. The phone calls were structured and aimed to motivate and encourage the participants and also to give them the opportunity to ask questions about the program. They were also asked to participate in an assessment after the treatment; if they agreed to this an appointment for a telephone assessment was booked. The phone calls lasted
Individualized Guided Internet-delivered Cognitive-Behavior Therapy for Chronic Pain Patients With Comorbid Depression and Anxiety A Randomized Controlled Trial Monica Buhrman, PhD,* Martin Syk, MSc,* Olle Burvall, MSc,* Terry Hartig, PhD,* Torsten Gordh, MD, PhD,w and Gerhard Andersson, PhDzy
Objectives: Depression and anxiety are commonly seen in patients with chronic pain which affects the patient’s daily life functioning. Although considerable attention has been devoted to explain why depression and anxiety are frequent comorbid with chronic pain, little empirical work has been conducted on interventions that target depression and anxiety and chronic pain. The present study was designed to test an individualized cognitive-behavioral treatment delivered through the internet for persons with chronic pain and emotional distress. Materials and Methods: A total of 52 patients with chronic pain and depression were included and randomized to either treatment for 8 weeks or to a control group that participated in a moderated online discussion forum. Results: Intent-to-treat analyses showed significant decreases regarding depressive symptoms and pain disability in the treatment group. Results on the primary outcomes of depression and anxiety were in favor of the treatment group. Reductions were also found on pain catastrophizing. Discussion: One-year follow-up showed maintenance of improvements. We conclude that an individualized guided internet-delivered treatment based on cognitive-behavior therapy can be effective for persons with chronic pain comorbid emotional distress. Key Words: individualized treatment, internet-delivered CBT, chronic pain, depression, anxiety, disability, CBT, guided self-help
(Clin J Pain 2015;31:504–516)
C
hronic pain often has adverse effects on daily activity, employment, relationships, and emotional functioning.1 The costs related to chronic pain in Europe and the United States is estimated at 14% of the country’s gross domestic product.2 People with chronic pain often experience high levels of disability3 in various life domains.4,5 Furthermore, chronic pain has been found to be associated Received for publication July 15, 2014; revised November 26, 2014; accepted October 22, 2014. From the *Department of Psychology; wPain Research, Department of Surgical Sciences, Uppsala University; zDepartment of Behavioural Sciences and Learning, Linko¨ping University, Linko¨ping University; and yPsychiatry Section, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. The authors declare no conflict of interest. Reprints: Monica Buhrman, PhD, Department of Psychology, Box 1225, 754 41 Uppsala, Sweden (e-mail: monica.buhrman@psyk. uu.se). Copyright r 2014 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/AJP.0000000000000176
504 | www.clinicalpain.com
with mood and anxiety disorders but also with somatoform, substance use, and personality disorders.6 The prevalence of major depressive disorder in chronic pain patients has been reported to range between 30% and 54%.4,6 Depression has been found to be associated with poor painrelated outcomes such as functional limitations.7 Moreover, persons with chronic pain and depression report greater disability and interference with daily activities.4 Depression has also been reported to be a predictor for the onset of disabling pain.8–10 The association between pain and depression has been found to be complicated in part because of the multidimensional nature of pain, with both sensory and affective dimensions.4 Pain intensity does not always correlate with depressed mood in chronic pain patients.11 Several factors seem to influence the paindepression relationship.12 For example, a longitudinal study showed that self-criticism in female patients contributed to the experience of subsequent depressive symptoms.13 Anxiety has also been documented to coexist with chronic pain.6 When overlooked, the comorbidity between pain and anxiety may reduce response to treatment.14 Furthermore, anxiety has been shown to be related to the experience and adjustment to pain.8,15 Thus, both depression and anxiety can be regarded as important targets for intervention in association with chronic pain. There is substantial body of research indicating the efficacy of cognitive-behavioral treatments (CBT) for chronic pain.16–18 However, for many people with chronic pain, CBT is not available. Other barriers such as geographic and economic circumstances can hinder individuals with chronic pain to obtain evidence-based treatments.12,19 Internet-based CBT (iCBT) is rapidly evolving as a means for overcoming many of the mentioned barriers.20 Several disorders have been studied with iCBT and results have been equivalent with face-to-face therapies,21 for example, panic disorder,22–24 social anxiety disorder,25,26 and depression.27,28 iCBT have been shown to be effective for depression and anxiety and a range of other disorders.29,30 Several reviews have reported the effects of iCBT for the treatment of chronic pain.31–33 iCBT can be guided by a clinician, where technology is used in conjunction with therapist contact to support the patient.30 The internet programs vary in length between 6 and 20 weeks and intervention often include a secure contact portal where the therapist and the patient can communicate. The support offered involves providing feedback on weekly reports, reminders to complete program activities. Outcomes include pain intensity, function level; and psychosocial Clin J Pain
Volume 31, Number 6, June 2015
Clin J Pain
Volume 31, Number 6, June 2015
measures; that is, depression and anxiety.31 In contrast, unguided iCBT is fully automated, and there are examples of unguided iCBT programs for chronic pain showing promising results.34,35 In 1 study 141 participants with chronic low back pain were randomly assigned to either a 3week iCBT intervention or a waitlist. The intervention contained information about pain, relaxation exercises, and cognitive and behavioral strategies to cope with pain. Treatment was unguided but participants were reminded to log in if they did not do so at least once per week. Results showed positive effects on pain-related outcomes such as disability, self-efficacy, fearful avoidance of physical activity, and pain catastrophizing.34 Results have shown that iCBT is associated with improvements in pain, activity limitation, and costs associated with treatment. The effects on depression and anxiety are, however, less consistent.31,32 A recent study36 showed that a clinician-guided iCBT program reduced disability, anxiety, and depression associated with chronic pain with moderate to large effect sizes. In the study, 63 adults with different diagnoses of chronic pain were randomized to either a treatment group or a waitlist control group. The treatment group received a CBT-based intervention during 8 weeks. The program content was based on the principles of CBT for anxiety and depression. A clinical psychologist provided weekly feedback through secure e-mail and telephone. Positive results were found on the different outcomes measuring disability, anxiety, depression, and average pain.36 In addition to the benefits of being accessible and cost-effective, iCBT can meet patients at different phases. For example, iCBT opens up the possibility to individualize the treatment for the patient. A study comparing individualized iCBT to standardized iCBT for depression and comorbid symptoms found that tailored iCBT was more effective for individuals with higher levels of depression and more comorbidity,37 and other studies on comorbid anxiety and depression show promising findings.38–40 Thus, given the comorbidity between chronic pain, depression, and anxiety, tailored iCBT could be a useful approach for this patient group.41 The purpose of the present study was to investigate if a guided individualized iCBT intervention could help persons with chronic pain with depression and anxiety. Participants were recruited from a clinical setting and advertisement. The active treatment group was compared with a moderated online discussion forum which has been used as an active intervention in previous studies.42 As CBT is effective for depression and anxiety and chronic pain treatment, it is possible to incorporate elements of CBT for depression, anxiety disorders, and chronic pain.14 An important component of the treatment program in the present study consisted of behavioral activation which has been shown effective for depression43,44 but also in the context of comorbid conditions such as obesity45 and chronic pain.46,47 There is also research showing that CBT can be effective for anxiety and comorbid chronic pain.47 Furthermore, in the present treatment package there was a possibility to include CBT for insomnia which has been shown to work for insomnia and comorbid chronic pain.48,49 Mindfulness was also a possible component in the treatment program. Research shows that mindfulness can improve depression and anxiety in patients with chronic pain (see meta-analysis50). Thus, tailoring iCBT for chronic pain may be a way to target comorbid problems that are not targeted in regular iCBT programs for chronic pain. The aim of this study was to conduct a randomized Copyright
r
Individualized Guided iCBT for Chronic Pain Patients
controlled trial to test this. Our hypothesis was that the treatment group would report significant improvements on measures of disability, depression, anxiety, catastrophizing, and quality of life.
METHODS Recruitment Procedure and Inclusion Participants were recruited from the Pain Centre at the Uppsala University hospital in Sweden and through an advertisement in a newspaper. Patients who had visited the Pain Centre the last year (n = 200) were contacted by telephone to receive information about the study. Interested individuals were asked to visit a Web site (http://www. studie.nu) where they could read more about the study and report their interest to participate. Individuals were asked to register an e-mail address. Information about how to register to access to the screening procedure were given. Inclusion criteria required that participants had undergone previous medical investigation(s) (within 1 y) to avoid participants with undiagnosed chronic pain disorders who needed further medical investigations, had chronic pain (ie, pain for >3 mo), had regular access to the internet, and had problem with depression and anxiety defined in the present study a total score of >10 points on the Montgomery A˚sberg Depression Rating Scale (MADRS-S) was defined as a depressive state51 and present psychological distress assessed in the structured telephone interview with Primary Care Evaluation of Mental Disorders (PRIMEMD). Exclusion criteria consisted of patients with ongoing medical investigations because that would intervene with the persons’ participation in the present trial, diagnosed dysthymia (as the present treatment did not focus on that kind of problem), ongoing treatment that could interfere with participation in the study, such as planned surgery and acute physical or psychiatric conditions that requires immediate treatment, for example, schizophrenia, dissociative disorder. In addition, participants had to be fluent in the Swedish language. The screening consisted of different forms and questions to see if the individual fulfilled the inclusion or exclusion criteria. The screening forms were presented on a secure web platform that required double authentication. Here the individuals were also asked to fill in an informed consent and they were informed about the security of the platform and that that they could interrupt participation in the study whenever they wanted. If the person had not filled in the screening questions a reminder was sent. After the participant had completed the online screening (including demographic questions such as perceived discomfort level, pain intensity, pain duration, previous contact with the health care system, psychiatric, and other somatic disorders) and pretreatment measures he or she was contacted by telephone for a structured interview that lasted approximately for 30 minutes. The clinical structure interview was based on the PRIME-MD, which is a diagnostic manual based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.52 PRIME-MD is used to screen for depression, anxiety disorders, alcohol abuse, somatoform diagnosis, and eating disorders.53 During the screening interview information about the study was also given. A total of 68 individuals registered their interest on the study on the Web site and 60 filled out the screening questions and measures. Of these, 57 persons went through
2014 Wolters Kluwer Health, Inc. All rights reserved.
www.clinicalpain.com |
505
Clin J Pain
Buhrman et al
the telephone interview. After the telephone interview, 52 individuals remained and were randomized to either the treatment (n = 28) or to the control group (n = 24). For more detailed information see Figure 1. Randomization was made by an independent person using a true random number service (http://www.randomizer.org). Participants
Volume 31, Number 6, June 2015
were informed about which group they had been randomly assigned to. Before randomization participants were informed that they would be randomized to either group 1 (the treatment group) or group 2 (the control condition). Group 1 was described as an internet-based treatment for depression for persons with chronic pain based on CBT
Inquiry by telephone, Pain Center (n=) and advertisement in local
Registered on the web interest to participate
(n=68)
Excluded (n=8) Did not activate registration code n=2 Did not complete inclusion forms n=6
Assessed for eligibility
total (n=60)
Excluded (n=3) Could not be reached: n=2 Did not fulfilled the inclusion criteria regarding MADRS-S, n=1
Telephone interview (n=59)
Meeting exclusion criteria (n=2)
Excluded (n=2) Declined participation: n=2
Completed inclusion forms and telephone interview
Suffered from acute psychiatric disorder: n=2
(n=57)
Not meeting inclusion criteria (n=1) Score 30 y 3 (6) Sex (n [%]) Men 8 (15) Women 44 (85) Education level (n [%]) Nine-year compulsory school 10 (19) Upper secondary school 12 (23) University education 2 y 27 (52) Work status (n [%]) Sick leave 9 (17) Works 17 (33) Unemployed 14 (27) Pensioner 14 (27) Other* 4 (8) Pain location (n [%])w Back 63 (33) Neck 52 (27) Shoulders 54 (28) Generalized pain 46 (24) Mental disorders according to the PRIME-MD (n [%]) Mild depression 6 (12) Major depression 31 (60) Depression partial remission 2 (4) Generalized anxiety disorder 0 (0) Social anxiety 8 (15) Panic disorder 4 (8) Obsessive compulsive disorder 8 (4) Anxiety unspecified 24 (46)
3 1 3 5 9 6 1
(11) (4) (11) (18) (32) (21) (4)
3 2 5 2 6 4 2
(13) (8) (21) (8) (25) (17) (8)
1 0 1 1 1 5
(11) (0) (11) (11) (11) (56)
4 (14) 24 (86)
4 (17) 20 (83)
1 (11) 8 (89)
6 5 3 14
(21) (18) (11) (50)
4 7 0 13
(17) (29) (0) (54)
2 2 1 4
(22) (22) (11) (44)
4 7 6 9 2
(14) (25) (21) (38) (8)
5 10 2 5 2
(21) (42) (8) (21) (8)
0 4 1 1 3
(0) (44) (11) (11) (33)
46 46 50 46
(13) (13) (14) (13)
83 58 42 46
(20) (14) (10) (11)
11 44 22 22
(1) (4) (2) (2)
4 20 2 2 5 3 4 12
(14) (71) (7) (7) (18) (11) (14) (43)
2 11 0 1 3 1 0 12
(8) (46) (0) (4) (13) (4) (0) (50)
1 2 0 0 1 1 1 3
(11) (22) (0) (0) (11) (11) (11) (33)
*For example, parental leave. wParticipants could choose several locations. PRIME-MD indicates Primary Care Evaluation of Mental Disorders.
Copyright
r
2014 Wolters Kluwer Health, Inc. All rights reserved.
www.clinicalpain.com |
507
Clin J Pain
Buhrman et al
week. Participants were asked to send in their assignments every week to their therapist. To receive access to the next part of the treatment, participants had to send in their weekly assignments before a specified date. The therapist gave feedback to the participants regarding their exercises within 24 hours of receipt during weekdays. The feedback given to the participants was mostly positive reinforcement and replies to the participant’s inquiries. A reminder was sent through the platform to participants who did not complete their assignments, that is, they received a text message that informed them they had a message on the Web site and prompted them to log in, if the person did not reply to 2 e-mails the participants was contacted by telephone. After 4 weeks of treatment, participants in the treatment group were telephoned for an assessment regarding technical aspects. The phone calls were structured and aimed to motivate and encourage the participants and also to give them the opportunity to ask questions about the program. They were also asked to participate in an assessment after the treatment; if they agreed to this an appointment for a telephone assessment was booked. The phone calls lasted
