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Butler M, Urosevic S, Desai P, et al. Treatment for Bipolar Disorder in Adults: A Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Aug. (Comparative Effectiveness Review, No. 208.)
Appendix Table K1Characteristics of eligible studies: CBT vs. inactive comparators
| Study, Year Design Location Funder Risk of Bias PMID | Randomized (N) Age (mean) Sex (% Female) Race (% White) Diagnosis (% BP I, II, NOS) Setting | Inclusions Key Exclusions | Intervention Description | Comparison Description | Follow-up Duration | Outcomes Reported Withdrawal (%) at endpoint |
|---|---|---|---|---|---|---|
| Jones, 20151 RCT United Kingdom Government Moderate 25213157 | N = 67 39 (18-65) Female 70% White 96% BP II 21% Outpatient | Euthymic/Maintenance; DSM-IV diagnosis of primary BP I or II (DSM-IV) with onset in past 5 years Schizoaffective | Individual CBT focused on recovery approach, mood functioning, understanding of diagnosis, recovery-informed goals, relationships between mood and progress towards recovery goals, CBT techniques to cope, functioning issues in relation to recovery, development of recovery plan, and sharing lessons from therapy with stakeholders -Total of 18 hours over 6 months; weekly or biweekly 45-60 minute sessions | Treatment as usual: Routine medication (mood stabilizers, antipsychotics, and antidepressants) and medical care from clinician and community mental health team. | 12 months 15 months (Relapse Only) | PSP QoL.BD BDI-II Relapse (SCID-LIFE, HRSD, MAS) Time to Recurrence 12 months: 33% 15 months: 54% |
| Perich, 20132 RCT Australia Government and Non-Government Moderate 23216045 | N=95 Age NR (18+) Female 65% White NR BP I 62% BP I 37% BP NOS 1% Outpatient | Euthymic/Maintenance; BP I or II (DSM-IV), on a mood stabilizing medication for the duration of study treatment with at least one bipolar disorder episode (hypo/mania, depression, mixed episode) over the previous 18 months; and a lifetime incidence of at least three bipolar episodes Schizoaffective; Substance Abuse; Other Mental Health; Neurological Disorders; Labs/Other Conditions | Group mindfulness-based CBT consisting of mindfulness meditation practice and cognitive therapy regarding depression including psycho- education (education about bipolar disorder, depression, hypo/mania, and anxiety). -8 weekly sessions, each 2 to 2.5 hours | Treatment as usual: Weekly handouts with information about bipolar disorder via email or mail. Topics included causes of bipolar disorder, available treatments, and common symptoms. | 12 months | MADRS YMRS Relapse (DSM-IV major depressive, hypomanic or manic episode) 38% |
| Fava, 20113 RCT Italy Government and Non-Government Low 21372621 | N = 62 Age 40 (18-65) Female 55% White NR Cyclothymic 100% Outpatient | No history of mania or major depressive disorder; Current diagnosis of cyclothymic disorder according to DSM-IV First Manic Episode; Schizoaffective; Substance Abuse; Other Mental Health; Neurological Disorders; Taking Other Medications; Pregnant/Nursing; Labs/Other Conditions | CBT and well-being therapy focused on patient’s symptomatology, monitoring of distress, strategies for symptom management, psychotherapeutic strategy for enhancing well-being -10 sessions every other week for 45-minutes. | Clinical Management: Reviewed the patient’s clinical status and provided the patient with support and advice according to protocol -10 sessions every other week for 45-minutes. | 24 months | CID MAS 18% |
| Gomes, 20114 RCT Brazil Government and Non-Government High 21372622 | N = 50 Age 39 (18-60) Female 76% White NR BP I 76% BP II 24% Outpatient | Euthymic/Maintenance; BP I or II (DSM-IV) with more than 5 years of schooling, and use of at least one mood stabilizer or atypical antipsychotic YMRS <6 HDRS <8 Substance Abuse; Neurological Disorders | Group CBT focused on information about BP and stabilized routine and pharmacological issues; use of mood graphs and stress vulnerability model, cognitive and behavioral strategies to manage depressive and manic episodes; specific problems in BP; techniques to improve relapse prevention -18 structured sessions, 90 minutes each | Treatment as usual: Pharmacological treatment | 24 months | Relapse (Not Defined) Time to relapse 6% |
| Castle, 20105 RCT Australia Government and Non-government Low 20435965 | N = 84 Age 42 (18-65) Female 76% White NR BP I 74% BP II 25% BP NOS 1% Outpatient | Euthymic/Maintenance; BP I, BP II, or BP NOS (DSM-IV); not in an acute episode as defined by DSM-IV criteria Schizoaffective; Neurological Disorders; Labs/Other Conditions | Group CBT focused on monitoring mood and activities, assessing prodromes, preventing relapse, and setting specific, measurable, achievable, realistic, time-framed goals -12 weekly group sessions (90 minutes) and 3 monthly booster sessions with weekly telephone calls | Treatment as usual (not defined) and weekly telephone call | 12 months | Relapse (DSM–IV–TR criteria for any mood episode) MADRS YMRS 14% |
| Ball, 20066 RCT Australia Non-government and industry High 16566624 | N = 52 Age 42 (23-77) Female 58% White NR BP NR Outpatient | Without current episode of severe depression or mania; BP I or BP II (DSM-IV) with at least 1 episode of hypomania, mania, or depression over prior 18 months; able to maintain usual mood stabilizing medications for duration of treatment. BDI<30 HAM-D-17 <15 YMRS<20 Schizoaffective; Other Mental Health; Neurological Disorders; Labs/Other Conditions | CBT focused on assessment, psychoeducation, identifying early warning signs, establishing stable routines, identifying and modifying cognitions, identifying and modifying schemas -20 weekly sessions, 60 minutes each | Treatment as usual: Regular sessions as prescribed by patient’s medical practitioner | 12 months | Relapse (DSM-IV hypo/manic, depressive, or mixed episodes at least 2 months after symptomatic remission) MADRS YMRS GAF SAS ATQ-N WHO-DAS 37% |
| Scott, 20067 RCT United Kingdom Government Low/High 16582056 | N = 253 Age 41 (18-65) Female 65% White NR BP I 94% BP II 6% Outpatient | Depressed, Hypo/manic, or Euthymic; BP I or BP II (DSM-IV) with history of two or more episodes of illness meeting DSM–IV criteria for mania, hypomania, major depressive disorder or mixed affective disorder, one of which must have been within 12 months of recruitment; and contact with mental health services within the past 6 months. First Manic Episode; Substance Abuse; Other Mental Health; Neurological Disorders | CBT focused on facilitating acceptance of the need for treatment, reducing variability in mood, managing stressors, strategies to cope with depression, identifying and modifying dysfunctional automatic thoughts and beliefs, improve medication adherence, tackling substance misuse, teaching early recognition of symptoms of recurrence and coping techniques for symptoms -Weekly sessions for 15 weeks with reduction in frequency from week 16-26. Two booster sessions week at 32 and 38. | Treatment as usual: Medication and contact with key mental health professionals when appropriate. | 18 months | Relapse LIFE-II, Depression LIFE-II, Mania 26% |
| Lam, 2003, 20059 RCT England NR Low Moderate 12578431 15677598 | N = 103 Age 44 (22-70) Female 56% White NR BP I 100% Outpatient | Euthymic/Maintenance; BP I (DSM-IV) with prescribed prophylactic medication at an adequate dose according to the British National Formulary, with at least 2 episodes in the last 2 years or 3 episodes in the last 5 years, but currently not fulfilling criteria for a bipolar episode; BDI <30 BRMS<9 First Manic Episode; Schizoaffective; Substance Abuse; Other Mental Health | CBT focused on traditional cognitive therapy for depression, diathesis-stress model and need for pharmaceutical and psychological therapy, mood monitoring and prodromes, sleep importance, and targeting extreme striving attitudes and behavior -12 to 18 individual 60-minute sessions in the first 6 months and 2 booster sessions in the second 6 months. | Minimal psychiatric care: Mood stabilizers (at appropriate level) and regular outpatient psychiatric follow up | 12 months 2.5 years | Relapse (DSM-IV criteria for any bipolar episode) HDRS BRMS SPS Hospitalizations 16% |
Abbrevaitions: BDI=Beck Depression inventory; BP=bipolar disorder; BRMS=Bech-Rafaelsen Mania Scale; CBT=Cognitive Behavioral Therapy; CID=Clinical Interview for Depression; DSM=Diagnostic and Statistical Manual of Mental Disorders; GAF=General Assessment of Functioning Scale; HAM-D=Hamilton Scale for Depression; HDRS=Hamilton Depression Rating Scale; LIFE=Longitudinal Interval Follow-up Evaluation; MADRS=Montgomery-Asberg Depression Rating Scale; MAS=Bech-Rafaelsen Mania Rating Scale; NOS=not otherwise specified; NR=not reported; PMID=PubMed Identification Number; PSP=Personal and Social Functioning Scale; QoL.BD=Quality of Life; RCT=randomized controlled trial; SCID=Sturctured Clinical Intervies for DSM Disorders; SPS=Social Phobia Scale; YMRS=Young Mania Rating Scale
Appendix Table K2Summary risk of bias assessments: CBT vs. inactive comparators
| Study Funding Source PMID | Overall Risk of Bias Assessment | Rationale |
|---|---|---|
| Jones 20151 Government 25213157 | Moderate | Potential bias due to rate of attrition at 12 months (~33%) and differential rate of attrition between study arms. |
| Perich 20132 Government and Non-Government 23216045 | Moderate | Potential reporting bias due to unclear reporting of sample sizes by arm. Almost 40% lost to follow up at outcome time points. |
| Fava 20113 Government and Non-Government 21372621 | Low | No significant suspected biases. |
| Gomes 20114 Government and Non-Government 21372622 | High | Suspected bias due to attrition post-randomization in treatment arm with high differential attrition between groups. |
| Castle 20105 Government and Non-Government 20435965 | Low | No significant suspected biases. |
| Ball 20066 Non-government and Industry 16566624 | High | Suspected bias due to unclear reporting of reasons for withdrawal by treatment arm. High differential attrition between groups. |
| Scott 20067 Government 16582056 | Low/High (Post-hoc analysis) | No significant suspected biases related to pre-specified outcomes; however, there is a risk of bias due to post-hoc analysis results. |
| Lam 20038 NR 12578431 | Low/High | No significant suspected biases for relapse outcomes; but there is a risk of bias due to unclear reporting of symptom scores and time points. |
| Lam 20059 NR 15677598 | Moderate | Suspected bias due to unclear reporting of attrition and sample size by arm. |
Abbreviations: NR=not reported; PMID=PubMed Identification Number
Appendix Table K3Outcomes summary: CBT vs. inactive comparators
| Study ROB PMID | Responder/Remitter | Symptom | Function | Other | AE |
|---|---|---|---|---|---|
| Jones, 20151 Moderate 25213158 | Relapse* NS 15 months, Any type OR= 0.32 (95% CI 0.09, 1.06); p=0.06 Time to First Recurrence Favors CBT HR=0.38 (95% CI 0.18, 0.78) | Depression* NS 6 months, BDI ES=0.00 (95% CI −0.58, 0.58) 12 months, BDI ES=0.02 (95% CI −0.63, 0.68) | Quality of Life* NS 6 months, QoL.BD ES= −0.36 (95% CI −0.93, 0.22) 12 months, QoL.BD ES= −0.35 (95% CI −1.01, 0.31 Social Function* NS 6 months, PSP ES= −0.38 (95% CI −1.00, 0.25) 12 months, PSP ES= −0.35 (95% CI −0.75, 0.60) | NR | NR |
| Perich, 20132 Moderate 23216045 | Relapse* NS 12 months, Depression OR= 0.67 (95% CI 0.19, 2.24); p=0.59 12 months, Hypo/manic OR= 1.90 (95% CI 0.59, 6.20); p=0.29 | Depression* NS 6 months, MADRS ES= 0.05 (95% CI −0.35, 0.46) 12 months, MADRS ES= 0.23 (95% CI −0.18, 0.63) Mania* NS 6 months, YMRS ES= −0.27 (95% CI −0.67, 0.13) 12 months, YMRS ES= 0.06 (95% CI −0.34, 0.46) | NR | NR | NR |
| Fava, 20113 Low 21372621 | NR | Depression* Favors CBT 6 months, CID ES= −0.67(95% CI −1.18, −0.15) 12 months, CID ES= −0.57 (95% CI −1.08, −0.06) Mania* Favors CBT 6 months, BRMS ES= −0.74 (95% CI −1.25, −0.22) 12 months, BRMS ES= −0.94 (95% CI −1.46, −0.41) | NR | NR | NR |
| Gomes, 20114 High 21372622 | Relapse* NS 24 months, Any type OR=0.37 (95% CI 0.37, 5.25); p=0.77 Time to First Recurrence Favors CBT Median: 31 weeks CBT vs. 11.5 weeks Usual care; p=0.01 | NR | NR | NR | NR |
| Castle, 20105 Low 20435965 | Relapse* Favors CBT 12 months, Any type OR=0.32 (95% CI 0.10, 0.95); p=0.03 | Depression* NS 12 months, MADRS ES=0.41 (95% CI −0.06, 0.87) Mania NS 12 months, YMRS ES=0.33 (95% CI −0.14, 0.80) | NR | NR | NR |
| Ball, 20066 High 16566624 | Relapse* NS 6 months, Any type OR=0.50 (95% CI 0.11, 2.07); p=0.36 18 months, Any type OR=0.74 (95% CI 0.22, 2.56); p=0.78 | Depression* Favors CBT at 6 months 6 months, MADRS ES=-0.57 (95% CI −1.12, −0.01) 18 months, MADRS ES=-0.08 (95% −0.62, 0.47) Mania* NS 6 months, YMRS ES= −0.02 (95% CI −0.56, 0.53) 18 months, YMRS ES= −0.13 (95% −0.67, 0.42) | Function* NS 6 months, GAF ES=0.43 (95% CI −0.12, 0.98) 18 months, GAF ES=0.24 (95% CI −0.30, 0.79) Social Function* NS 6 months, SAS ES=-0.48 (95% CI −1.03, 0.08) 18 months, SAS ES=-0.17 (95% −0.71, 0.38) Cognitive Function* NS 6 months, ATQ-N ES=-0.37 (95% CI −0.91, 0.18) 18 months, ATQ-N ES=0.22 (95% CI −0.32, 0.77) Health and Disability* Favors Intervention 6 months, WHO-DAS ES=-0.58 (95% CI −1.13, −0.02) NS 18 months, WHO-DAS ES=-0.40 (95% CI −0.95, 0.15) | NR | NR |
| Scott, 20067 16582056 | Relapse* NS 9 months, Any type OR=0.99 (95% CI 0.56, 1.75); p=0.97 12 months, Any type OR=0.84 (95% CI 0.50, 1.42); p=0.53 | Depression* 18 months, LIFE-II Depression NS Mania* NS 18 months, LIFE-II Mania | NR | NR | NR |
| Lam, 20038 12578431 | Relapse* Favors CBT at 18 and 30 months 6 months, Any type OR=0.39 (95% CI 0.15, 1.03); p=0.05 18 months, Any type OR= 0.26 (95% CI 0.10, 0.67); p=0.00 30 months, Any type OR=0.33 (95% CI 0.11, 0.94); p=0.02 | Depression* NS 6 months, HDRS ES= −0.17 (95% CI −0.56, 0.22) 12 months, HDRS ES= −0.13 (95% CI −0.52, 0.26) Mania* NS 6 months, BRMS ES=0.00 (95% CI −0.39, 0.39) 12 months, BRMS ES= −0.32 (95% CI −0.71, 0.07) | Social Function* Favors CBT at 6 months 6 months, SPS ES= −0.60 (95% CI −0.99, −0.20) 12 months, SPS ES=0.00 (−0.39, 0.39) | Admissions for BP 12 months Favors CBT OR=0.20 (95% CI 0.06, 0.61) | NR |
- *
=Self-calculated estimate based on reported data
Abbreviations: ATQ-N=Automatic Thoughts Questionnaire Negative Subscale; BP=Bipolar Disorder; BDI=Beck depression inventory; BRMS=Bech-Rafaelsen Mania Scale; CBT=Cognitive Behavioral Therapy; CI=Confidence Interval; ES=Effect Size; GAF=General Assessment of Functioning Scale; HR=Hazard Ratio; LIFE=Longitudinal Interval Follow-up Evaluation; MADRS=Montgomery-Asberg Depression Rating Scale; NR=not reported; NS=not significant; OR=Odds Ratio; PMID=PubMed Identification Number; QoL.BD=Quality of Life; ROB=risk of bias; SAS=Simpson Angus Scale; SPS=Social Phobia Scale; WHO-DAS=World Health Organization Disability Assessment Scale; YMRS = Young Mania Rating Scale
Appendix Table K4Summary of strength of evidence: CBT vs. inactive comparators
| Outcome | Timing | # Studies/Design (n analyzed) | Finding or Summary Statistic | Study Limitations | Consistency | Directness | Precision | Overall Grade/Conclusion |
|---|---|---|---|---|---|---|---|---|
| Relapse | 6 months 7-12 months 12+ months | 7 RCTs (n=714) | Mixed evidence with no clear direction of effect. No pattern across time periods. | Moderate | Inconsistent | Direct | Imprecise | Insufficient |
| Depression | 6 months 7-12 months 12+ months | 7 RCTs (n=716) | Mixed evidence with no clear direction of effect. No pattern across time periods. | Moderate | Inconsistent | Direct | Imprecise | Insufficient |
| Mania | 6 months 7-12 months 12+ months | 6 RCTs (n=649) | Mixed evidence with no clear direction of effect. No pattern across time periods. | Moderate | Inconsistent | Direct | Imprecise | Insufficient |
| Global Function | 6 months 12+ months | 1 RCT (n=52) | No difference between groups at 6 or 18 months. 6 months. GAF ES=0.43 (95% CI −0.12, 0.98) 18 months, GAF ES=0.24 (95% CI −0.30, 0.79) | Moderate | Unclear | Direct | Imprecise | Insufficient |
| Other Measures of Function | 6 months 7-12 months 12+ months | 3 RCTs (n=289) | Mixed evidence with no clear direction of effect. No pattern across time periods. | Moderate | Inconsistent | Direct | Imprecise | Insufficient |
Abbreviations: CBT=Cognitive Behavioral Therapy; CI=Confidence Interval; ES=Effect Size; GAF=General Assessment of Functioning Scale; RCT=randomized controlled trial
Appendix Table K5Characteristics of eligible studies: CBT vs. active comparators
| Study, Year Design Location Funder Risk of Bias PMID | Randomized (N) Age (mean) Sex (% Female) Race (% White) Diagnosis (% BP I, II, NOS) Setting | Inclusions Key Exclusions | Intervention Description | Comparison Description | Follow-up Duration | Outcomes Reported Withdrawal (%) at endpoint |
|---|---|---|---|---|---|---|
| Harvey, 201510 RCT United States Government Moderate 25622197 | N = 58 Age 37 (18-62) Female 62% White 64% BP I 100% Outpatient | No current bipolar episode; BP I(DSM-IV); interepisode defined by YMRS score <12 and an IDS-C score <24 for the past week, with general insomnia disorder (International Classification of Sleep Disorders, DSM–IV–TR criteria for primary insomnia) but without the exclusion for mental disorder, had a stable medication regimen for the past 4 weeks, had a treating psychiatrist Substance Abuse; Other Mental Health; Neurological Disorders; Pregnant/Nursing; Labs/Other Conditions | CBT for insomnia focusing on stimulus control, bed and sleep associations, regularizing sleep and wake times, sleep/circadian education, relaxing wind down, sleep-enhancing activities, and devising a wake-up routine. The module altered unhelpful beliefs about sleep, bedtime worry, rumination, and vigilance -8 weekly 50-60 minute sessions with behavioral module | Psychoeducation sessions that provided information but no facilitation or plan for behavior change. Sessions focused on mood regulation, the etiology of bipolar disorder, symptoms, prodromes, medications, substance use, diet, physical activity, stress management, relaxation, and self-esteem and sleep in a social context -8 weekly 50-60 minute sessions | 6 months | Relapse (emergence of a new syndromal DSM–IV–TR bipolar episode) YMRS IDS-C SDS-Mood Q-LES-Q-SF 29% |
| Meyer, 201211 RCT Germany Non-government Low 22099722 | N = 76 Age 44 (18-75) Female 50% White NR BP 79% BP II 21% Outpatient | Euthymic/Maintenance; Primary diagnosis of BP (DSM-IV), without a current major effective episode, and willingness to continue current or start medication. Schizoaffective; Substance Abuse; Other Mental Health; Neurological Disorders; Taking Other Medications | CBT focused on understanding of BP, identifying early warning symptoms, strategies for management, communication and problem solving skills -20 sessions over 9 months, 50-60 minutes each | Supportive Therapy: Client-centered focus; whatever problems the patient presented were dealt with by providing emotional support and general advice -20 sessions over 9 months, 50-60 minutes each. | 24 months | Relapse (Any mood episode that fulfilled DSM-IV criteria) BDI BRMAS GAS 15% |
| Parikh, 201212 RCT Canada Government and Non-Government Low 22795205 | N = 204 Age 40.9 (18-64) Female 58% White NR BP I 72% BP II 28% Outpatient | Euthymic/Maintenance; Age 18-64; BP I or II (DSM-IV) with at least 2 episodes of significant symptoms or full episodes within previous 3 years; no episode in month preceding randomization First Manic Episode; Substance Abuse; Other Mental Health; Neurological Disorders; Labs/Other Conditions | CBT including psychoeducation, understanding of personal warning signs for onset and action plan, and cognitive restructuring of dysfunctional thoughts and assumptions -20 individual 50-minute sessions | Group psychoeducation using Life Goals manual; focused on illness recognition, treatment approaches, and coping strategies and the creation of Personal Care Plan including action plan for both depression and mania -6 sessions, 90 minutes each session | 18 months | Relapse (Not Described) LIFE Depression LIFE Mania 38% |
| Weiss, 200913 RCT United States Government Low 19573999 | N = 61 Age 38 (18-58) Female 41% White 91.8% BP I 79% BP II 15% BP NOS 6% Outpatient | Non-manic; Current diagnosis of BP (DSM-IV) and substance abuse other than nicotine, substance abuse within 60 days, a mood stabilizer regimen for more than 2 weeks, ability to attend group sessions and follow-up, without current mania. First Manic Episode; Schizoaffective; Other Mental Health; Labs/Other Conditions | Integrated group CBT on the cognitive-behavioral relapse prevention model which focuses on the similarities between recovery and relapse processes in bipolar disorder and substance abuse and their interaction -12 weekly 60-minute sessions | Group Drug Therapy: Substance use disorder therapy sessions that focused on facilitating abstinence, encouraging mutual support, and teaching new ways to cope with substance-related problems -12 weekly 60-minute sessions | 6 months | HAM-D YMRS 19.6% |
| Weiss, 200714 RCT United States Government and Non-Government Moderate 17202550 | N = 62 Age 41.9 (22-65) Female 51.6% White 93.5% BP I 81% BP II 16% BP NOS 3% Outpatient | Maintenance; A current diagnosis of bipolar disorder (DSM-IV) and substance dependence other than nicotine; substance use within 60 days; a mood stabilizer regimen for ≥2 weeks; and age ≥18 First Manic Episode; Schizoaffective; Other Mental Health; Labs/Other Conditions | Integrated group CBT on cognitive-behavioral relapse prevention model which focuses on the similarities between recovery and relapse processes in bipolar disorder and substance abuse and their interaction -20 weekly 60-minute sessions | Group Drug Therapy: Focused on facilitating abstinence, encouraging mutual support, and teaching new ways to cope with substance-related problems -20 weekly 60-minute sessions | 8 months | HAM-D YMRS 34% |
Abbreviations: BDI=Beck depression inventory; BP=bipolar disorder; BRMS=Bech-Rafaelsen Mania Scale; CBT=Cognitive Behavioral Therapy; DSM=Diagnostic and Statistical Manual of Mental Disorders; GAS=Global Assessment Scale; HAM-D=Hamilton Scale for Depression; IDS=Inventory for Depressive Symptoms; LIFE=Longitudinal Interval Follow-up Evaluation; NOS=not otherwise specified; NR=not reported; PMID=PubMed Identification Number; Q-LES-Q-SF=Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form; RCT=randomized controlled trial; SDS-Mood=Sheehan Disability Scale-Mood; YMRS = Young Mania Rating Scale
Appendix Table K6Summary risk of bias assessments: CBT vs. active comparators
| Study Funding Source PMID | Overall Risk of Bias Assessment | Rationale |
|---|---|---|
| Harvey, 201510 Government 25622197 | Moderate | Potential bias due to differential attrition rates between arms. |
| Meyer, 201211 Non-Government 22099722 | Low | No significant suspected biases. |
| Parikh, 201212 Government and Non-Government 22795205 | Low | No significant suspected biases. |
| Weiss, 200913 Government 19573999 | Low | No significant suspected biases. |
| Weiss, 200714 Government and Non-Government 17202550 | Moderate | Potential bias due to incomplete outcome reported and unclear reporting of methods for analysis of data. |
Abbreviations: PMID=PubMed Identification Number
Appendix Table K7Outcomes summary: CBT vs. active comparators
| Study Risk of Bias PMID | Responder/Remitter | Symptom | Function | Other | AE |
|---|---|---|---|---|---|
| Harvey, 201510 Moderate 25622197 | Relapse 6 months, Favors CBT Hypo/manic 4.6% CBT vs. 31.6% Psychoeducation, p = .036 Relapse NS 6 months, Depressive 9.1% CBT vs. 21.1% Psychoeducation, p = 0.39. | Depression NS 6 months, IDS-C ES= −0.30; p=0.33 Mania NS 6 months, YMRS ES= −0.02; p=0.60 | Quality of Life NS 6 months, Q-LES-Q-SF ES=−0.47 (95% CI −0.99, 0.05) DisabilityNS 6 months, SDS-Mood ES=0.24 (95% CI −0.27, 0.76) | NR | NR |
| Meyer, 201211 Low 22099722 | Relapse NS 9 months, Any type OR=0.42 (95% CI 0.15, 1.16); p=0.10 30 months, Any type OR=1.41 (95% CI 0.50, 4.05); p=0.63 | Depression NS 9 months, BDI No statistical test reported Mania NS 9 months, BRMAS ES=0.33 (95% CI −0.16, 0.82) | Global Function NS 9 months, GAS ES=−0.20 (95% CI −0.68, 0.29) | NR | NR |
| Parikh, 201212 Low 22795205 | Relapse NS 18 months, Hypomanic/manic p=0.46 Relapse NS 18 months, Depressive p=0.76 | Depression NS 18 months, LIFE Depression p=0.89 Mania NS 18 months, LIFE Mania p=0.96 | NR | NR | NR |
| Weiss, 200913 Low 19573999 | NR | Depression NS 6 months, HAM-D No statistical test reported Mania NS 6 months, YMRS No statistical test reported ES=−0.54 (95% CI −1.05, −0.03) | NR | NR | NR |
| Weiss, 200714 17202550 | NR | Depression NS 8 months, HRSD Mania NS 8 months, YMRS | NR | NR | NR |
Abbreviations: BDI=Beck depression inventory; CBT=Cognitive Behavioral Therapy; CI=Confidence Interval; ES=Effect Size; GAS=Global Assessment Scale; HAM-D=Hamilton Scale for Depression; HRSD=Hamilton Rating Scale for Depression; IDS=Inventory for Depressive Symptoms; LIFE=Longitudinal Interval Follow-up Evaluation; NR=not reported; NS=not significant; OR=Odds Ratio; PMID=PubMed Identification Number; Q-LES-Q=Quality of Life Enjoyment and Satisfaction Questionnaire; SDS-Mood=Sheehan Disability Scale-Mood; YMRS=Young Mania Rating Scale
Appendix Table K8Summary of strength of evidence: CBT vs. active comparators
| Outcome | Timing | # Studies/Design (n analyzed) | Finding or Summary Statistic | Study Limitations | Consistency | Directness | Precision | Overall Grade/Conclusion |
|---|---|---|---|---|---|---|---|---|
| Relapse | 6 months 7-12 months 12+ months | 3 RCTs (n=338) | Mixed evidence with no clear direction of effect. No pattern across time periods. | Moderate | Inconsistent | Direct | Imprecise | Insufficient |
| Depression | 6 months 7-12 months 12+ months | 5 RCTs (n=461) | No difference between groups across range of time periods. | Moderate | Consistent | Direct | Imprecise* | Low; No effect from intervention |
| Mania | 6 months 7-12 months 12+ months | 5 RCTs (n=461) | No difference between groups across range of time periods | Moderate | Consistent | Direct | Imprecise* | Low; No effect from intervention |
| Global Function | 9 months | 1 RCT (n=76) | No difference between groups at 9 months ES=−0.20 (95% CI −0.68, 0.29) | Low | Unclear | Direct | Imprecise | Insufficient |
| Other Measures of Function | 6 months | 1 RCT (n=58) | No difference between groups at 6 months in either QoL or disability. Q-LES-Q-SF ES=−0.47 (95% CI −0.99, 0.05) SDS-Mood ES=0.24 (95% CI −0.27, 0.76) | Low | Unclear | Direct | Imprecise | Insufficient |
- *
It is difficult to establish a level of precision that provides confidence of no effect. Due to the large number of comparisons with findings of no effect, we assessed strength of evidence cautiously when there was imprecision, only assigning low strength of evidence when there was sufficient sample size, low to moderate study limitations, and consistency
Abbreviations: CBT=Cognitive Behavioral Therapy; CI=Confidence Interval; ES=Effect Size; Q-LES-Q=Quality of Life Enjoyment and Satisfaction Questionnaire; RCT=randomized controlled trial; SDS-Mood=Sheehan Disability Scale-Mood
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