TITLE: Group Therapy for Adults with Axis II Disorders: A Review of Clinical Effectiveness

Transcription

1 TITLE: Group Therapy for Adults with Axis II Disorders: A Review of Clinical Effectiveness DATE: 19 November 2009 CONTEXT AND POLICY ISSUES: Axis II disorders include personality disorders and mental retardation. 1 According to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV-R), personality disorder is a pattern of inner experience and behavior that deviates markedly from the expectations of the individual s culture, is pervasive and inflexible and leads to distress or impairment. 1 Personality disorder is stable over time and is usually recognizable during adolescence. 1 The DSM-IV R states that there are 10 personality disorders; these are: paranoid personality disorder schizoid personality disorder antisocial personality disorder borderline personality disorder histrionic personality disorder narcissistic personality disorder avoidant personality disorder dependent personality disorder obsessive-compulsive personality disorder personality disorder not otherwise specified. (p29) 1 Individuals suffering with different personality disorders present with differing diagnostic features. For example, borderline personality disorder is defined as an individual having a pervasive pattern of instability of interpersonal relationships, self-image, and affects, and marked impulsivity ; 1 an individual with paranoid personality disorder would have a pattern of pervasive distrust and suspiciousness of others such that their motives are interpreted as malevolent. 1 Each personality disorder has its own set of diagnostic criteria, prevalence, and differential diagnoses. 1 While medication can be used to treat Axis II disorders, there is also a need for psychotherapy. 2 Group therapy is one method of treating patients with a personality disorder. Group therapy can occur in a variety of settings such as day hospitals, inpatient units, or a therapeutic community. 3 Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

2 The objective of this HTIS report is to assess the evidence regarding group therapy for individuals with Axis II disorders. RESEARCH QUESTION: What is the clinical effectiveness of group therapy interventions for the treatment of adults with Axis II disorders? METHODS: A focused search (whose main concepts appeared in the subject heading) was conducted in Medline and PsycINFO. A limited literature search was conducted on all other key health technology assessment resources, including PubMed in process, The Cochrane Library (Issue 3, 2009), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, EuroScan, international health technology agencies, and a focused Internet search. The search was limited to English language articles published between 2004 and September Filters were applied to limit the retrieval to health technology assessments, systematic reviews, meta-analyses, randomized controlled trials (RCTs), controlled clinical trials, and observational studies. To be included, studies had to focus on personality disorder, assess the effectiveness of group therapy alone, and report on health-related outcomes. Clinical studies did not require a comparator group; however, case studies were not included. An additional reference that may be of interest has been included in Appendix 1. Where available from the original studies, estimates of between group differences and corresponding 95% confidence intervals (CIs) have been reported to summarize differences between groups. Where this information was not available, other summary measures reported in the original studies (such as p-values or means accompanied by standard deviations) have been reported. SUMMARY OF FINDINGS: The literature search identified four relevant RCTs 2,4-6 that assessed therapies for borderline personality disorder, and one observational study 7 that assessed therapies for avoidant personality disorder. Despite differences in the group therapy used, all RCTs found that the experimental group therapy generally resulted in benefits for patients as assessed using a variety of outcome measures. Group therapy included schema focused group therapy, 2 dialectical behaviour therapy skills training, 4 Systems Training for Emotional Predictability and Problem Solving (STEPPS), 5 and acceptance-based emotion regulation group therapy. 6 The observational study 7 did not find that integrated wilderness group therapy affected patients scores on clinical rating scales. Two commonly used assessment tools were The Symptom Check List-90 and The Clinical Global Index- Borderline Personality Disorder. No information was identified for several types of personality disorders or for mental retardation. No relevant health technology assessments, systematic reviews and meta-analyses, or controlled clinical trials were identified. A summary of the methods and findings of the included five studies follows below. A pair of tables has been provided in Appendix 2 which highlights additional relevant details of these studies. This Group Therapy for Adults with Axis II Disorders 2

3 information includes patient inclusion and exclusion criteria, interventions compared, treatment program structure sessions, duration), a listing of study outcomes evaluated, length of follow-up, and a checklist of study methodology criteria (including randomization, allocation concealment, blinding, reporting of a priori sample size calculations, and withdrawal information). Randomized controlled trials In 2009, Farrell et al. 2 published details of an RCT that evaluated the effectiveness of a schemafocused group therapy in addition to individual therapy to treat female patients with diagnosed borderline personality disorder (experimental group; number of patients = 16) compared to only individual treatment as usual (control group; number of patients = 16). The authors developed and had previously piloted a 30 session, eight month, manual-based schema therapy group program. The authors stated that the focus of the program was to identify and change maladaptive schemas and coping strategies. The program had four components: emotional awareness training, borderline personality disorder psychoeducation, distress management training, and schema change work. The success of the program was assessed through a decrease in severity and frequency of borderline personality disorder symptoms and a decrease in the severity of global psychiatric symptoms, and improved global function. The four tools used to measure these aspects of success were: Borderline Syndrome Index, Symptom Check List-90, Diagnostic Interview for Borderline Personality Disorders-Revised, and Global Assessment of Function Scale. Patients were assessed at baseline, when the treatment period ended, and six months after the treatment ended. No patients in the experimental group were lost to follow-up while four patients withdrew from the control group. Statistical analyses of the outcome measures showed that, when compared to the control group, the experimental group demonstrated a greater decrease in severity and frequency of symptoms, as well as a greater improvement in global function at both the end of the treatment and six months afterwards. Within-group analyses compared baseline outcome measures to those at subsequent follow ups and revealed that the experimental group saw improvements on the outcomes measured and the control group did not. Regarding disease status following treatment, 15 of the 16 patients scores on the Borderline Syndrome Index no longer met the criteria for borderline personality disorder in the experimental group compared to 1 of the twelve control group patients (Odds Ratio 165 [95% CI = 9.27, 2936]). The same pattern was found with the Diagnostic Interview for Borderline Personality Disorders-Revised scores; more patients in the experimental group scored below the threshold for diagnosing borderline personality disorder based on the Diagnostic Interview for Borderline Personality Disorders (15 of 16 patients in the experimental group compared to three of 12 patients in the control group; Odds Ratio 45 [95% CI = 4.04, 501]). Compared to baseline, the Global Assessment of Functioning Scale scores in the experimental group s mean score changed from a rating of serious symptoms to a mean score that indicated mild symptoms for the experimental group. The control group mean remained in the serious symptom category. No statements were made regarding clinically meaningful improvements on the Symptom Checklist-90 Revised measure. The authors of the trial concluded that group schema focused therapy in addition to weekly individual psychotherapy resulted in both statistically significant and clinically significant improvements in all assessment measures for females with borderline personality disorder. The authors cautioned that the lack of improvement in the control group patients may in part be explained by the lack of borderline personality disorder specialization in individual psychotherapy in the community. Group Therapy for Adults with Axis II Disorders 3

4 In 2009, Soler et al. 4 published findings from a single-blinded RCT comparing the skills training component of dialectical based therapy patients = 29) to standard group therapy patients = 30) for patients with borderline personality disorder. Patients were recruited from outpatient facilities and emergency services. The treatment period was 13 weeks. Each session lasted two hours, and had a male and female therapist in each group. Each group contained between nine and 11 patients. Patients did not receive additional psychotherapy. Dialectical behaviour therapy skills training for the patient traditionally involves group therapy (approximately two hours per week), individual psychotherapy (approximately one hour per week), and phone calls. In this study, the focus was on assessing the effectiveness of the skills training alone in patients with borderline personality disorder. The skills training portion focused on training patients in interpersonal problem solving and assertion; emotional regulation; attention control, nonjudgmental awareness and sense of true self; and acceptance of painful emotion without trying to change them. Within the sessions, there was teaching and practice of the new skills along with homework assignments. To accommodate for the shortened length of therapy, the authors provided additional homework, as well as a brief mindfulness exercise at the start of each session. The control group was enrolled in a standard group therapy that focused on patients sharing their difficulties and the therapists were the conductor in group interactions. A total of 10 patients withdrew from the experimental group, and 19 patients withdrew from the control group. The authors presented pre- and post-treatment data for patients who completed the study. The authors stated that patients in the experimental group scored statistically significantly better on 14 of the 17 reported measures assessed (comparison to a priori stated minimal clinically important difference was not reported). Briefly, the patients in the experimental group performed statistically significantly better on the global indices of both the Symptom Checklist-90 Revised (2.47 [0.85] versus 2.09 [1.07], P < 0.05) and the Clinical Global Index Borderline Personality Disorder (4.78 [0.80] versus 3.50 [1.20], P < 0.001). In addition, patients in the experimental group had statistically significant improvement on the suicide subscale of the Clinical Global Index Borderline Personality Disorder (3.17 [1.38] versus 2.44 [1.24], P < 0.05). The control group scored statistically significantly better on the global subscale of the Clinical Global Index Borderline Personality Disorder (4.89 [0.33] versus 4.44 [0.52], P < 0.05), but not on the Global Symptom Checklist-90 Revised or the suicide subscale of the Clinical Global Index-Borderline Personality Disorder. Using the last observation carried forward in the treatment period, it was found that patients in the experimental group were more likely to be rated very much or much improved in the Clinical Global Impression severity and improvement ratings (40.0% compared to 5.1%, P < 0.001), and global self-ratings (58.5% compared to 22.0%, P = 0.023). Patients in the experimental group were also more likely to reach the clinically relevant cutoff (score > 60) for the Global Assessment Scale (18.5% compared to 5.1%, P = 0.023). Repeated measures analyses comparing the experimental group and control group at one-year follow up revealed no statistically significant differences on Clinical Global Index Borderline Personality Disorder, the Global Symptom Checklist- 90 Revised or the suicide subscale of the Clinical Global Index-Borderline Personality Disorder. There were no differences in terms of self-harm behaviours, suicides, or emergency visits (data was not provided). The authors concluded that compared to standard group therapy, dialectical behaviour therapy skills training was associated with greater retention and greater reduction of symptoms associated with borderline personality disorder but did not reduce characteristic behaviours such as suicide or self harm. Group Therapy for Adults with Axis II Disorders 4

5 In 2008, Blum et al. 5 published findings from an RCT that assessed the clinical effectiveness of STEPPS plus usual therapy patients = 65) versus usual therapy alone patients = 59) in patients with borderline personality disorder after 20 weeks of follow-up. The patients were recruited from inpatient and outpatient psychiatric services in Iowa, as well as through other means including mental health centers and word of mouth. Group sizes ranged between eight and 12 patients. STEPPS is a manual-based group treatment program for patients with borderline personality disorder. It is an outpatient program lasting 20 weeks (two hours per week) that follows detailed lesson plans. The three main components of STEPPS are psycho-education, emotion management skills training, and behaviour management skills training. Usual treatment included whatever the patients had for usual care, which might have included individual psychotherapy, medication, and/or case management. The authors compared the mean rates of change of several outcomes observed in the experimental and control groups, and reported that the experimental group change was statistically significantly greater for the Zanarini Rating Scale, Clinical Global Impression Improvement and Severity scales, Global Assessment Scale, and the Symptom Checklist-90 Revised. These improvements suggest that the experimental group experienced more improvement in borderline personality disorder symptoms than the control group. No associated statistics (including mean between group differences and corresponding 95% CIs) were reported. When the scores at the last follow-up were compared to one year follow up, there were no statistically significant differences across time for either group, indicating that the benefits of therapy were maintained. The authors stated that 82 (66%) of patients had at least one assessment during the one-year follow up. With regard to behavioural outcomes, the authors reported that there were no differences in the number of months in which at least one crisis call was made (2.49 months for the experimental group compared to months for the control group), or the number of months in which at least one hospitalization occurred (1.13 months for the experimental group compared to 1.24 for the control group). No comparisons were made between groups for self-harm data or suicide attempts. However, the time to first suicide attempt or self-harm act was analyzed using a Cox proportional hazards model and no statistically significant differences were found. The authors concluded that STEPPS plus treatment as usual group provided clinically meaningful improvements and was superior to the treatment as usual group. The authors hypothesized that a longer treatment may have resulted in greater improvements in the STEPPS patient group. Gratz et al. 6 reported findings from an RCT published in 2006 that compared an acceptance-based emotion regulation group intervention along with usual treatment (experimental group; number of patients = 13) to usual treatment alone (control group; number of patients = 11). The patients were women with borderline personality disorder who engaged in self-harm behaviour. Patients were referred through clinicians at one hospital in Boston as well as private clinics in the Boston area. Usual treatment consisted of outpatient therapy that included both individual therapy and group therapy. The amount of therapy varied between patients. The emotion regulation group intervention was based on Acceptance and Commitment Therapy, dialectical behaviour therapy, emotionfocused psychotherapy, and traditional behaviour therapy. Three examples of the modules covered were, Function of self-harm behaviour, Primary vs. secondary emotions, and Impulse control. The sessions combined psychoeducation and group exercises that included daily practice of skills, as well as regular homework assignments that included a daily monitoring diary. The treatment period was 14 weeks, and group therapy occurred during 1.5 hour weekly sessions. Patients were assessed two weeks prior to the start of the study and approximately one week after the study ended. Group Therapy for Adults with Axis II Disorders 5

6 Of the 24 patients randomized, one patient from each group withdrew, leaving 12 in the experimental group and 10 in the control group. Analysis of data collected two weeks after the completion of treatment showed that there were statistically significant differences on all measures except for the lack of clarity subscale on the Difficulties in Emotion Regulation Scale. The authors reported that there were large differences between the groups, but no other clinically meaningful information was presented. The authors also examined changes over time within each group, and found that while the control group showed no difference, the experimental group achieved statistically significant improvements on all measures. The authors also stated that the differences between groups were large, but did not provide further details. For clinical relevance, the authors noted that in the experimental group: 50% of patients reported a reliable improvement in borderline personality disorder symptoms, 42% had scores in the normal range for stress level, and 83% had scores in the normal range for emotion dysregulation and experiential avoidance. With regard to self-harm, 42% of the experimental patients reported a reduction in such behavior of 75% or greater. The authors concluded that the emotion regulation group had positive results on patients with regard to emotion dysregulation, experiential avoidance, self-harm behaviour, and borderline personality specific symptoms of depression, anxiety, and stress. The authors cautioned that the results were preliminary, but suggested that the results were likely attributable to the effect of the group therapy. Observational study In 2006, Eikenæs et al. 7 published details of a study that compared a treatment program referred to as integrated wilderness therapy (experimental group; number of patients = 16) to inpatient group therapy (control group; number of patients = 37) in patients with avoidant personality disorder. The authors selected the experimental group from a national psychiatric hospital. The experimental treatment consisted of a six day wilderness therapy trip that included a three day canoeing trip and daily group therapy. It was closed group therapy, where sharing was the main focus. Patients were provided with challenges and experiences where mastery could be experienced. The patients all had specific items such as tents, cooking equipment, and supplies. The patients could not bring extra food, extra equipment, or watches. The control group was a retrospective sample of 37 patients who had been treated in the hospital s inpatient group program and had completed the Inventory of Interpersonal Problems at pre-care or admission and again at one-year follow-up. The patients in the control group were selected from the hospital database, and were treated between 1992 and The control group was treated in slow-open groups with an interpersonal focus on different problems. The control group experienced three small group sessions, two large group sessions, and one expressive art therapy each week. The patients in both the experimental and control groups completed several self-reported clinical rating scales, including The Global Symptom Index of the Symptom Check List-90 at pre-care, admission, discharge, and one-year follow up. The authors reported that The Global Symptom Index of the Symptom Check List 90 has good psychometric properties. Two people from the experimental group withdrew at follow-up, and the scores at discharge from these patients were carried forward as their one year follow-up score. Statistical analysis indicate a possible difference in the way men and women responded to the different types of therapy; the authors reported that in the experimental group, the men improved and the women did not, and in the control group, the women improved and the men performed slightly worse. No statistics were provided to support Group Therapy for Adults with Axis II Disorders 6

7 these statements. Within the experimental group, there was a statistically significant improvement on the Global Symptom Index scores over time. The authors stated that the overall results did not provide evidence of additional benefit for integrated wilderness therapy compared to the control group. However, there were statistically significant improvements in both the experimental and control groups. The authors discussed that men may respond better to the experimental group therapy whereas women may respond better to the control group therapy. However, these results were not statistically significant. Limitations The methodology of this HTIS report facilitates an efficient and timely report; thus limitations on the search strategy were employed. For example, non English, unpublished, and non peerreviewed articles were not searched. Patients with Axis II personality disorders are not a homogenous group, and thus there may be different predictors of success to consider when determining whether a group therapy should be used and which group therapy should be used. It was beyond the scope of this HTIS report to consider the predictors associated with successful group therapies. Short-term results may provide insight into what strategies may be effective. However, no studies followed patients for lengthy periods of time; thus, it is unknown how long the effects of group therapy last. All of the included studies were considered to be at a risk of bias. This was due to several factors, including the following: None of the studies reported sufficient methodological detail to enable determination of whether group assignment was adequately concealed. The included studies either did not blind 2,5-7 or could not guarantee blinding remained successful. 4 None of the studies reported a priori sample size calculations; thus, it is unknown whether there was sufficient statistical power to reliably detect statistically significant differences with the sample sizes of the study. In several analyses across trials, numbers of patients analyzed were not reported and were unclear. In most cases, the authors conclusions were not reported as between group differences with corresponding 95% confidence intervals, and instead conventional statistical significance in the form of p-values was used to summarize testing of hypotheses. Most studies failed to report minimally clinically important differences corresponding to the outcome measures collected. Most of the studies focused on self-reported clinical rating scales which may have introduced bias into the results, as patients may have adjusted their responses (that is, introduction of the risk of social desirability bias). Also, there was a lack of detailed reporting on the effect of group therapy on negative behaviours like self-injury and hospitalizations. Group Therapy for Adults with Axis II Disorders 7

8 The results of the included studies are difficult to generalize, as studies focused on mainly Caucasian females. One study 5 acknowledged that findings from their study may not be generalizable to males, minorities, or patients with recent suicidal or self harm behaviors. It is important to note that statistically significant differences do not necessarily indicate the presence of clinically meaningful differences. Consistent reporting of established minimum clinically important differences, particularly when dealing with rating scales as outcome measures, would have facilitated interpretation as to whether group therapy was clinically effective. CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING: The four RCTs 2,4-6 included in this review all concluded that in the treatment of borderline personality disorder, the group therapy studied was beneficial for symptom reduction, as measured by self-reported clinical rating scales. One study reported that there were clinically meaningful differences 2 benefiting the schema-focused group therapy patients on all administered scales. None of the studies reported mean differences between groups and corresponding confidence intervals to facilitate interpretation. While group therapy for patients with borderline personality disorder resulted in statistically significant increases up to one year post treatment, some of which were also described as clinically significant, it remains unknown whether the effects of therapy continue to last past this time point. In addition, given the study populations of the included studies, the findings may not be generalizable to groups other than Caucasian females with borderline personality disorder. It is also unclear whether group therapy would be effective for varying degrees of borderline personality disorder or when borderline personality disorder exists amidst other disorders such as Axis I disorders. One observational study 7 was identified that examined the role of an integrated wilderness group therapy for patients with avoidance personality disorder. This study did not find evidence to support that group therapy was more beneficial than treatment as usual for this patient population; however, statistically significant improvements were seen within each group. Two reports provided minimal data regarding group therapy s effects on hospitalizations, self-injury, or use of emergency services. 4,7 More comprehensive reporting of such outcomes would be useful in establishing the clinical effectiveness of group therapy. Other study design and reporting considerations that would help establish clinical effectiveness of group therapy include the use of longer follow up times, studying other patient populations (other than Caucasian females), and reporting of 95% confidence intervals of mean between group differences with comparison to corresponding established minimum clinically important differences. There is some evidence to tentatively suggest that a few different group therapies can be effective for patients with borderline personality disorder up to one year following completion of treatment. There is minimal evidence that group therapy improves symptoms in patients with antisocial personality disorder. There is no evidence to help determine whether group therapy would be beneficial to other Axis II disorders. Group Therapy for Adults with Axis II Disorders 8

9 PREPARED BY: Rhonda Boudreau, BA (Hons), BEd, MA, Research Officer Carolyn Spry, BSc, MLIS, Information Specialist Raymond Banks, AB, MA, MLS, Information Specialist Health Technology Inquiry Service Tel: Group Therapy for Adults with Axis II Disorders 9

10 REFERENCES: 1. Diagnostic and statistical manual of mental disorders. 4th ed, text revision. Washington: American Psychiatric Association; p. 2. Farrell JM, Shaw IA, Webber MA. A schema-focused approach to group psychotherapy for outpatients with borderline personality disorder: a randomized controlled trial. J Behav Ther Exp Psychiatry Jun;40(2): Winship G, Hardy S. Perspectives on the prevalence and treatment of personality disorder. J Psychiatr Ment Health Nurs Apr;14(2): Soler J, Pascual JC, Tiana T, Cebria A, Barrachina J, Campins MJ, et al. Dialectical behaviour therapy skills training compared to standard group therapy in borderline personality disorder: a 3-month randomised controlled clinical trial. Behav Res Ther. 2009;47(5): Blum N, John D, Pfohl B, Stuart S, McCormick B, Allen J, et al. Systems Training for Emotional Predictability and Problem Solving (STEPPS) for outpatients with borderline personality disorder: A randomized controlled trial and 1-year follow-up. Am J Psychiatry. 2008;165(4): Gratz KL, Gunderson JG. Preliminary data on an acceptance-based emotion regulation group intervention for deliberate self-harm among women with borderline personality disorder. Behav Ther Mar;37(1): Eikenaes I, Gude T, Hoffart A. Integrated wilderness therapy for avoidant personality disorder. Nord J Psychiatry. 2006;60(4): Group Therapy for Adults with Axis II Disorders 10

11 APPENDIX 1: ADDITIONAL REFERENCES Center for Substance Abuse Treatment. Substance abuse treatment: group therapy [Internet]. Rockville (MD): US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration; (Treatment Improvement Protocol (TIP) Series 41). DHHS Publication No.: (SMA) [cited 2009 Nov 19]. Available from: Group Therapy for Adults with Axis II Disorders 11

12 APPENDIX 2: ADDITIONAL INFORMATION FOR INCLUDED STUDIES Table 1: Summary of Findings Study (Year) Patient population, inclusion and exclusion criteria Randomized Controlled Trials Farrell et al. Diagnosed BPD, (2009) 2 referred by psychotherapists; in individual therapy for > 6 months and agreed to remain in individual therapy for the duration of the study Soler et al (2009) 4 Diagnosed BPD based on DSM-IV criteria; aged 18 to 45 years; not in psychotherapy; no substance dependence, schizophrenia, or bipolar disorder. Interventions compared patients) Schema-focused group therapy with individual usual treatment (number of patients = 16) versus individual usual treatment patients = 16) Skills training component of dialectical behaviour therapy patients = 29) versus standard group therapy patients = 30) Sessions, duration Patient traits Study outcomes, Follow-up 30 session, 8 month, manual-based schema therapy group program with 4 components: emotional awareness training, borderline personality disorder psychoeducation, distress management training, and schema change work 13 weekly sessions, 2 hour each session Patients on pharmacological therapy permitted to continue, but not allowed to change type or dose of medication Sex: 100% female Mean age (SD), years: Experimental group, 35.3 (9.30) Control group, 35.9 (8.08) Other: All had a history of suicide attempts and self-injury in prior two years Sex: Experimental group, 79.3% female Control group, 86.7% female Mean age (range), years: Borderline Syndrome Index, Symptom Check List- 90, Diagnostic Interview for Borderline Personality Disorders- Revised, Global Assessment of Function Scale Follow up: end of treatment (8 months), 6 months after completion of treatment Clinical Global Impression -BPD; Symptom Checklist- 90 Revised; self-injury, suicide attempts, and visits to psychiatric emergency services. Summary of main results Group schema focused therapy in addition to weekly individual psychotherapy resulted in statistically and clinically significant improvements in all assessment measures for females with borderline personality disorder. Dialectical behaviour therapy skills training was associated with greater retention and greater clinical improvements than standard group therapy Group Therapy for Adults with Axis II Disorders 12

13 Study (Year) Patient population, inclusion and exclusion criteria Interventions compared patients) Sessions, duration Patient traits Study outcomes, Follow-up Experimental, 28.5 (19 to 41) Summary of main results Blum et al Diagnosed BPD (2008) 5 according to DSM-IV criteria; could not have previously been in a STEPPS program; no substance abuse problem. Gratz et al Women with BPD (2006) 6 engaging in selfharm behavior Aged 18 to 60 years of age; 5 or more criteria for BPD; score 8 on the Revised Diagnostic Interview for STEPPS with usual therapy patients = 65) versus usual therapy alone patients = 59) Acceptance-based emotion regulation group intervention and usual treatment (number of patients = 13) versus usual treatment alone patients = 11) STEPPS: 20 weeks, 2 hours per week; manual-based training program following detailed lessons focused on psychoeducation, emotion management skills, behavior management skills. Usual therapy: whatever previously received (psychotherapy, medication, et cetera) 1.5 hr sessions once weekly for 14 weeks Emotion regulation group intervention: based on Acceptance and Commitment Therapy, dialectical behaviour therapy, Control, 26.0 (21 to 39 ) Sex: 83% female 94% white, 72% a history of suicide attempts, 73% currently in individual therapy, 73% a history of psychiatric hospitalizations. Mean age (SD) years: 31.5 (9.5) Sex: 100% female Mean age (SD), years: Experimental Group, 33 (12.47) Zanarini Rating Scale for BPD; Clinical Global Impression- Improvement; Clinical Global Impression Severity; Global Assessment Scale; Symptom Checklist- 90 Revised; hospitalizations, emergency department visits, crisis phone calls, suicide attempts, and self-harm acts. Deliberate Self-Harm Inventory, the Difficulties in Emotion Regulation Scale, and the Borderline Evaluation of Severity over Time STEPPS plus treatment as usual group provided clinically meaningful improvements and was superior to usual treatment. The emotion regulation group had positive results on patients with regard to emotion dysregulation, experiential avoidance, self-harm behaviour, and borderline personality specific symptoms of Group Therapy for Adults with Axis II Disorders 13

14 Study (Year) Patient population, inclusion and exclusion criteria Borderlines; recent history of self-harm; no suicide attempts in past 6 months; no participation in dialectical behaviour therapy in past 6 months. Observational Study Eikenaes et Patients with al (2006) 7 avoidant personality disorder based on DSM-IV criteria; no anxiety disorder failure to discontinue habituating meds, alcohol, or other substances Interventions compared patients) Integrated wilderness therapy patients = 16) versus inpatient group therapy patients = 37) Sessions, duration Patient traits Study outcomes, Follow-up emotion-focused psychotherapy, and traditional behaviour therapy Usual treatment: outpatient therapy that included both individual therapy and group therapy Integrated wilderness therapy: six day wilderness trip that included a three day canoe trip and daily closed group therapy. Inpatient group therapy: slow-open groups with an interpersonal focus on different problems. Patients experienced three small group sessions, two large group sessions, and one expressive art therapy each week. Control Group, 33.7 (12.56) Sex: Experimental group, 56% female Control group, 68% female Mean age (SD), years: Experimental group, 36 (9.1) Control group, 37 (11.4) Self-report clinical rating scales, including The Global Symptom Index of the Symptom Check List-90 at precare, admission, discharge, and oneyear follow up. Summary of main results depression, anxiety, and stress. The authors cautioned that the results were preliminary but stated that the results are likely attributable to the effect of the group therapy. Overall results did not find evidence for differences between groups. However, statistically significant improvements were seen in both groups on Global Symptom Index scores. There was some indication that men responded better to the experimental group and women responded better to the control group. Groups staffed by Group Therapy for Adults with Axis II Disorders 14

15 Study (Year) Patient population, inclusion and exclusion criteria Interventions compared patients) Sessions, duration Patient traits Study outcomes, Follow-up similar personnel: two psychiatric nurses, one social worker, one occupational therapist, and a physician specializing psychiatrist; Supervised by an experienced psychiatrist and doctor of clinical psychology. Summary of main results BPD = borderline personality disorder; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, Fourth edition; STEPPS = Systems Training for Emotional Predictability and Problem Solving Group Therapy for Adults with Axis II Disorders 15

16 Table 2: Methodology Details of Included Studies Study Adequate allocation concealment? Blinded? Used validated instruments? Imbalances at baseline? Reported sample size calculation? Withdrawal info given? Was there much? No Yes No No Yes Randomized Controlled Trials Farrell et al Unclear (2009) 2 4 control group patients, 0 experimental group patients Other comments Limited generalizability due to participants being all female and had to be referred into study from their psychotherapists, patients. The authors stated that the results may in part be explained by less than optimal individual psychotherapy in control group. Soler et al (2009) 4 Unclear Yes Single - outcome assessors (unclear if patients revealed group status) Yes No No Yes 10 experimental group, 19 control group. 1 additional withdrawal in experimental group may reflect an excluded experimental patient who did not get treatment. Sample sizes for some analyses were unclear. 19 of the 20 withdrawals included in analysis, though unclear what was done for missing data. Group Therapy for Adults with Axis II Disorders 16

17 Study Adequate allocation concealment? Blinded? Used validated instruments? Imbalances at baseline? Reported sample size calculation? Withdrawal info given? Was there much? Other comments Blum et al (2008) 5 Unclear No Unclear Yes More control group patients had avoidance personality disorder No Yes 20 in experimental group did not complete intervention, 8 in control group did not complete intervention 82 assessed at least once during one year follow up The authors acknowledged that their study was not generalizable to men, minorities, or to patients with recent suicidal or self-harm behaviours. Sample sizes for analyses were not always reported. A last observation carried forward approach to analysis was used. Three of the authors received royalties from a STEPPS CD-ROM. Gratz et al (2006) 6 Unclear No Yes Yes Experimental group had higher scores on the lack of clarity subscale on Difficulties in Emotion Regulation Scale No No But sample sizes appeared complete in the results table The authors did not report intention-to-treat analyses. Group Therapy for Adults with Axis II Disorders 17

18 Study Adequate allocation concealment? Blinded? Used validated instruments? Imbalances at baseline? Observational Study Eikenaes et No al (2006) 7 No No Yes Control group patients had a longer mean length of hospital stay. More experimental group patients used antidepressant medication. More experimental group patients had been previously admitted to the particular study hospital Reported sample size calculation? No Withdrawal info given? Was there much? No But control group was 100% (as was a retrospective sample selected by participation). Other comments Control group was a historical sample from a different time period The authors reported patient differences (meaningful differences in control group patients who completed one year follow up) may have introduced bias into the study or limited generalizability of results. Authors indicated limited statistical power as a result of small sample size. Group Therapy for Adults with Axis II Disorders 18