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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 M1Characteristics of eligible studies: family or partner interventions vs. inactive comparator
| 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 |
|---|---|---|---|---|---|---|
| D’Souza, 20101 RCT Australia Non-Government Low 19428117 | N=58 Age 41 (19-60) Female 52% White NR BP I 86% BP II 14% Outpatient | Euthymic/Maintenance: Recently remitted patients with a YMRS score <10 and a MADRS score <8 recruited within one month of discharge from hospital for bipolar relapse (MINI). Substance Abuse; Other Mental Health; Labs/Other Conditions | Patient/companion group psychoeducation consisting of discussion of symptoms, medications, and warning signs, and resources as well as psychotherapy -12 weekly sessions, 90 minutes each session | Treatment as usual: Community based case management involving weekly review with a mental health clinician and a monthly medical review -Weekly sessions for 45 minutes | 15 months | MADRS YMRS Relapse (BP) symptoms requiring hospital admission or intensive community psychiatric intervention) Time to relapse Withdrawal 22% |
| Miller 20042 Solomon 20083 Miller 20084 RCT US Government High High Moderate 15555694 19032711 18363424 | N=92 Age 39 (18-65) Female 57% White NR BP I 100% Outpatient | Current Episode: Inpatients, partial inpatients, or outpatients with BP I (DSM-III), a current episode (mania, depression, mixed) without alcohol or drug dependence within the past 12 months and living or in regular contact with a relative or significant other Substance abuse | Individual or group family therapy consisting of semi-structured family interventions. Individual therapy was based on McMaster Model of Family Function and group therapy included sessions focused on signs and symptoms, patient and family perspectives, and coping mechanisms. -6 to 10 sessions of family therapy, 50 minutes per session OR -6 weekly group sessions, 90 minutes per session | Pharmacotherapy: Mood stabilizer with other medications as necessary | 28 months | Recovery (Two consecutive months with BRMS <6 and HDRS <7) Relapse (HDRS 17-item score >15 or BRMS score > 9 after recovery) Time to recurrence Hospitalizations Withdrawal 35% |
Abbreviations: BP=bipolar disorder; BRMS=Bech-Rafaelsen Mania Scale; DSM=Diagnostic and Statistical Manual of Mental Disorders; HDRS=Hamilton Depression Rating Scale; MADRS=Montgomery-Asberg Depression Rating Scale; MINI=MINI International Nueropsychiatric Interview; NOS=not otherwise specified; NR=not reported; PMID=PubMed Identification Number; RCT=randomized controlled trial; YMRS = Young Mania Rating Scale
Appendix Table M2Summary risk of bias assessments: family or partner interventions vs. inactive comparators
| Study Funder PMID | Overall Risk of Bias Assessment | Rationale |
|---|---|---|
| D’Souza, 20101 Non-Government 19428117 | Low | No significant suspected biases. |
| Miller 20084 Government 15555694 | High | Suspected bias due to unclear reporting of randomization and attrition. |
| Solomon 20083 Government 19032711 | High | Suspected bias due to unclear reporting of randomization and attrition. |
| Miller 20042 Government 18363424 | Moderate | Suspected bias due to attrition rate of 35%. |
Abbreviations: PMID=PubMed Identification Number
Appendix Table M3Outcomes summary: family or partner interventions vs. inactive comparators
| Study PMID Risk of Bias | Responder/Remitter | Symptom | Function | Other | AE |
|---|---|---|---|---|---|
| D’Souza, 20102 19428117 Low | Relapse* 15 months, Any Type Favors FPI OR=0.17 (95% CI 0.03, 0.78); p=0.02 | Depression* 15 months, MADRS NS ES=−0.15 (95% CI −0.66, 0.37) Mania* 15 months, YMRS Favors FPI ES=−0.78 (95% CI −1.31, −0.24) | NR | NR | NR |
| Miller 20084 19032711 High Solomon 20083 18363424 Moderate Miller 20042 15555694 High | Relapse* 15 months, Any Type NS Individual Therapy OR=1.32 (95% CI 0.24, 7.34); p=0.50 Group Therapy OR=0.98 (95% CI 0.20, 4.51); p=0.62 Recovery 28 months NS; p=0.21 Number Recovered Individual Therapy: 16.0 Group Therapy: 21.0 Comparator: 16.0 Time to Recurrence 28 months NS; p=0.75 Months (Median) Individual Therapy: 6.0 Group Therapy: 8.0 Comparator: 12.0 Time to Recovery 28 months NS; p=0.55 Months (Median) Individual Therapy: 10 Group Therapy: 7 Comparator: 8 | NR | NR | Hospitalizations 28 months Favors FPI; p=0.04 Number of Hospitalizations Individual Therapy: 5 Group Therapy: 1 Comparator: 6 | NR |
Abbreviations: CI=Confidence Interval; ES=effect size; FPI=family and partner interventions; MADRS=Montgomery-Asberg Depression Rating Scale; NR=not reported; NS=not significant; OR=Odds Ratio; PMID=PubMed Identification Number; YMRS = Young Mania Rating Scale
Appendix Table M4Summary of strength of evidence: family or partner interventions vs. inactive comparators
| Outcome | Timing | # Studies/Design (n analyzed) | Finding or Summary Statistic | Study Limitations | Consistency | Directness | Precision | Overall Grade/Conclusion |
|---|---|---|---|---|---|---|---|---|
| Relapse | 12+ months | 2 RCTs (n=150) | Mixed evidence with no clear direction of effect. No pattern across time periods. | Low | Inconsistent | Direct | Imprecise | Insufficient |
| Depression | 12+ months | 1 RCT (n=58) | No difference between groups at 15 months. MADRS ES=−0.15 (95% CI −0.66, 0.37) | Low | Unclear | Direct | Imprecise | Insufficient |
| Mania | 12+ months | 1 RCT (n=58) | Favors FPI at 15 months. YMRS ES=−0.78 (95% CI −1.31, −0.24) | Low | Unclear | Direct | Imprecise | Insufficient |
| Global Function | NR | - | - | - | - | - | - | - |
| Other Measures of Function | NR | - | - | - | - | - | - | - |
Abbreviations: CI=Confidence Interval; ES=effect size; FPI=family and partner interventions; MADRS=Montgomery-Asberg Depression Rating Scale; NR=not reported; RCT=Randomized Control Trial; YMRS = Young Mania Rating Scale
Appendix Table M5Characteristics of eligible studies: family or partner interventions 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 |
|---|---|---|---|---|---|---|
| Wenze, 20155 RCT US Government and Non-Government Moderate 26117247 | N=30 Age 47 (24-68) Female 50% White 90% BP I 77% BP II 13% BP NOS 10% Inpatient/Outpatient | No current clinical state excluded; Inpatients or at-risk outpatients diagnosed with BP I, II, or NOS (DSM-IV) and drug/alcohol abuse disorder (DSM-IV) with a current prescription for a mood stabilizing medication and access to a telephone Other Mental Health; Pregnant/Nursing; Labs/Other Conditions | Integrated Treatment Adherence Program based on a cognitive behavioral approach focused on transitioning patients from acute to maintenance care using patient and family or significant other meetings in person and via telephone. -3 individual in-person sessions, 60 minutes per session; a 60 minute in-person session with family session, and 11 phone contacts held separately with subject and designated family member or significant other | Enhanced Assessment and Monitoring consisting of treatment as usual with enhanced monitoring (battery of interview-rated and self-report assessments followed by feedback letters) | 6 months | QIDS-C CARS-M WHO-DAS Hospitalizations ER Visits Withdrawal 27% |
| Miklowitz, 20006 Miklowitz, 20037 RCT US Government and Non-Government Low Low 11018229 12963672 | N=101 Age 36 (18-56) Female 63% White NR BP I 100% Inpatient/Outpatient | No current clinical state excluded: Inpatients with BP I (DSM-III) who had experienced a depressed, manic, or mixed episode in the past 3 months living with or having regular contact with close relatives Substance Abuse; Neurological Disorders; Labs/Other Conditions | Family-focused therapy with pharmacotherapy consisting of psychoeducation, developing communication skills, and learning a framework for defining problems and implementing solutions. -Uo to 21 family or martial sessions over 9 months, 60 minutes per session | Family education (2 sessions) and crisis management consisting of treatment as usual with emergency counseling sessions as needed and monthly telephone calls with patient | 24 months | SADS-C Depression SADS-C Mania Relapse (NR) Withdrawal 22% |
| Rea, 20038 RCT US Government and Non-Government Low 12795572 | N=53 Age 26 (18-46) Female 57% White 60% BP I NR Inpatient/Outpatient | Manic; Inpatients with bipolar disorder (DSM-III), manic type currently taking mood-regulating medications with a close family member that could participate in intervention with patient. Substance Abuse; Labs/Other Conditions | Family-focused treatment (with medication management) consisting of psychoeducation, communication enhancement training, and problem-solving skills training -21 therapy sessions over 9 months (60 minutes per session) with 1 year of medication management | Individual treatment (with medication management) consisting of meeting a therapist to receive education about illness and symptoms, discuss problem-solving, and establishing goals. -21 therapy sessions over 9 months (30 minutes per session) with 1 year of medication management | 24 months | Relapse (6 or 7 on BPRS/SADS-C core symptoms of depression, mania, or psychosis, and at least two ancillary symptoms) Withdrawal 45% |
| SImoneau, 19999 RCT US Government and Non-Government Moderate 10609423 | N=79 Age 34 (18-57) Female 54% White NR BP I NR Outpatient | Depressive, Manic, or Mixed Episode; Diagnosis of BP (DSM-III) in a manic, mixed, or depressed phase in the 3 months prior including month of study entry, living or in close contact with a relative for at least 1 to 3 months prior to study entry, and willing to take mood stabilizing medications Substance Abuse; Labs/Other Conditions | Family-focused therapy (with medication management) consisting of psychoeducation, communication-enhancement training, and problem-solving skills training -21 sessions over 9 months | Crisis management with naturalistic follow-up (with medication management) consisting of two sessions of home-based family education, crisis intervention as needed, telephone counseling and individual support sessions as needed, and monthly contacts. -9 months of management | 24 months | SADS-C Withdrawal 44% |
Abbreviations: BP=bipolar disorder; BPRS=Brief Psychiatric Rating Scale; CARS-M=Clinician-Administered Rating Scale for Mania; DSM=Diagnostic and Statistical Manual of Mental Disorders; NOS=not otherwise specified; NR=not reported; PMID=PubMed Identification Number; QIDS-C=Quick Inventory of Depression Scores; RCT=randomized controlled trial; SADS-C=Schedule for Affective Disorders and Schizophrenia-Change version; WHO-DAS=World Health Organization Disability Assessment Scale;
Appendix Table M6Summary risk of bias assessments: family or partner interventions vs. active comparators
| Study Funder PMID | Overall Risk of Bias Assessment | Rationale |
|---|---|---|
| Wenze, 20155 Government and Non-Government 26117247 | Moderate | Suspected bias due to format of data reporting and incomplete reporting of outcomes. |
| Miklowitz, 20037 Miklowitz, 20006 Government and Non-Government 11018229 12963672 | Low | No significant suspected biases. |
| Rea, 20038 Government and Non-Government 12795572 | Low | No significant suspected biases. |
| SImoneau. 19999 Government and Non-Government 10609423 | Moderate | Suspected bias due to differential attrition rate between study arms. |
Abbreviations: PMID=PubMed Identification Number
Appendix Table M7Outcomes summary: family or partner interventions vs. active comparators
| Study PMID | Responder/Remitter | Symptom | Function | Other | AE |
|---|---|---|---|---|---|
| Wenze 20155 26117247 | NR | Depression 6 months, QIDS-C Favors FPI; p<0.05 ES=0.24 Mania 6 months, CARS-M Favors FPI; p<0.05 ES=0.37 | Health and Disability 6 months, WHO-DAS Favors FPI; p<0.05 ES=0.12 | Re-Hospitalizations 6 months NS Emergency Room Visits 6 months NS; p<0.10 | NR |
| Miklowitz 20037 12963672 Miklowitz 20006 11018229 | Relapse* 12 months, Any Type NS OR=0.36 (95% CI 0.11, 1.09); p=0.05 Favors FPI 24 months, Any Type OR=0.22 (95% CI 0.07, 0.66); p=0.00 | Depression 24 months, SADS-C Depression Favors FPI; p=0.005 Mania 24 months, SADS-C Mania NS; p=0.06 | NR | NR | NR |
| Rea 20038 12795572 | Relapse 12 months NS; p>0.10 Family/Partner Therapy: 46% Active Comparator: 52% 1-year Post-Treatment Period (24 months) Favors FPI; p<0.05 FPI: 28% Active Comparator: 60% | NR | NR | NR | NR |
| Simoneau 19999 10609423 | NR | Symptoms 1 year post-treatment, SADS-C Favors FPI; p<0.05 | NR | NR | NR |
Abbreviations: CARS-M=Clinician-Administered Rating Scale for Mania; CI=Confidence Interval; FPI=Family or Partner Intervention; NR=not reported; NS=not significant; OR=Odds Ratio; PMID=PubMed Identification Number; QIDS-C=Quick Inventory of Depression Scores; SADS-C=Schedule for Affective Disorders and Schizophrenia- Change version; WHO-DAS=World Health Organization Disability Assessment Scale
Appendix Table M8Summary of strength of evidence: family or partner interventions vs. active comparators
| Outcome | Timing | # Studies/Design (n analyzed) | Finding or Summary Statistic | Study Limitations | Consistency | Directness | Precision | Overall Grade/Conclusion |
|---|---|---|---|---|---|---|---|---|
| Relapse | 7-12 months 12+ months | 2 RCTs (n=154) | No difference between groups at 12 months; however FPI groups experience fewer relapses at 24 months. | Low | Consistent | Direct | Imprecise | Insufficient |
| Depression | 6 months 12+ months | 2 RCTS (n=131) | Favors FPI at reported time periods. | Moderate | Consistent | Direct | Imprecise | Insufficient |
| Mania | 6 months 12+ months | 2 RCTS (n=131) | Mixed evidence with no clear direction of effect. No pattern across time periods. | Moderate | Inconsistent | Direct | Imprecise | Insufficient |
| Global Function | NR | - | - | - | - | - | - | - |
| Other Measures of Function | 6 months | 1 RCT (n=30) | Favors FPI at 6 months. WHO-DAS ES=0.12; p<0.05 | Moderate | Unclear | Direct | Imprecise | Insufficient |
Abbreviations: ES=Effect Size; FPI=Family or Partner Intervention; NR=not reported; RCT=randomized controlled trial; WHO-DAS=World Health Organization Disability Assessment Scale
References for Appendix M
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- Miller IW, Solomon DA, Ryan CE, et al Does adjunctive family therapy enhance recovery from bipolar I mood episodes? Journal of Affective Disorders. 2004 Nov 1;82(3):431–6. PMID: 15555694. [PubMed: 15555694]
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- Miller IW, Keitner GI, Ryan CE, et al Family treatment for bipolar disorder: family impairment by treatment interactions. Journal of Clinical Psychiatry. 2008 May;69(5):732–40. PMID: 18363424. [PMC free article: PMC2862220] [PubMed: 18363424]
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- Rea MM, Tompson MC, Miklowitz DJ, et al Family-focused treatment versus individual treatment for bipolar disorder: results of a randomized clinical trial. Journal of Consulting & Clinical Psychology. 2003 Jun;71(3):482–92. PMID: 12795572. [PubMed: 12795572]
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