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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 P1Characteristics of eligible studies: STEP-BD study and other psychosocial interventions
| 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 | Followup Duration | Outcomes Reported Withdrawal (%) at endpoint |
|---|---|---|---|---|---|---|
| Depp, 20151 RCT US Government Low 25479050 | N=104 Age 48 (22-74) Female 59% White 70% BP I 88% BP II 12% Outpatient | Without severe symptoms; Outpatients with BP (DSM-IV) currently prescribed medications for bipolar disorder without severe depressive (MADRS >32) or manic (YMRS> 20) Substance Abuse; Other Mental Health | Psychoeducation followed by use of a smart phone that delivered interactive elements via a mobile web-based program that delivered questionnaires and responses based on symptoms or early warning signs -4 sessions of psychoeducation followed by smart intervention (2 surveys per day) for 10 weeks | Psychoeducation followed by binder with paper and pencil mood charts. Monitored remotely via cell phone and had to turn in completed charts at the end of study. -4 sessions of psychoeducation followed by mood charts once per day for 10 weeks | 6 months | MADRS YMRS Withdrawal 22% |
| Faurholt-Jepsen, 20152 RCT Denmark Government and Non-Government Low 26220802 | N=78 Age 29 (18-60) Female 82% White NR BP I 82% Outpatient | No current clinical state excluded; Individuals with a BP diagnosis (ICD-10 and Schedules for Clinical Assessment in Neuropsychiatry) with a HDRS ≤17 and a YMRS ≤17 Other Mental Health; Pregnant/Nursing; Labs/Other Conditions | Smartphone with self-monitoring system that documented mood, sleep length, activity, medication taken, irritability, cognitive problems, alcohol consumption, stress, menstruation, and early warning signs. Patients could see visual representations of data to self-monitor. System included feedback loop with clinic and contact with study nurse. -6 months of self-monitoring | Smartphone without self-monitoring system and nurse contact if needed. -6 months of smart phone access | 6 months | HAMD-17 YMRS FAST WHO-Qol-bref Withdrawal 14% |
| Deckersbach 20143 Miklowitz 20074 Miklowitz 2007b5 RCT US Government and Non-Government High Moderate High 24077657 17728418 17404119 | N=293 Age 40 (18-62) Female 59% White 91% BP I 67% BP II 31% BP NOS 2% Outpatient | Major Depressive Episode; BP I or II (DSM-IV) with current major depressive episode (but no mixed episode or depression not otherwise specified), currently being treated with a mood stabilizer (or willing to initiate), not currently undergoing psychotherapy (or willing to discontinue) Substance Abuse; Other Mental Health; Pregnant/Nursing; Labs/Other Conditions | Intensive psychotherapy consisting of one of the following: 1) individual CBT consisting psychoeducation, life events scheduling, cognitive restructuring, problem-solving, strategies for early detection, and interventions for comorbidities, 2) IPSRT consisting of selecting a primary problem area and teaching patients about the Social Rhythm Metric and interpersonal problem resolution, or 3) family-focused therapy which encouraged patients and relatives to develop a common understanding, develop a relapse prevention plan, participate in communication enhancement exercises, and identify and solve problems related to illness or the home environment. -30 50-minute sessions over 9 months | Collaborative care consisting of a reviewing a psychoeducational videotape and workbook and developing a treatment contract. Worbook included information about BP, schedule management and mood charting, improving communication skills, an developing a treatment contract. -Three 50-minute individual sessions | 12 months | Recovery LIFE-RIFT Withdrawal 48% |
Abbreviations: BP=bipolar disorder; CBT= Cognitive Behavioral Therapy; DSM=Diagnostic and Statistical Manual of Mental Disorders; FAST= Functioning Assessment Short Test; HAMD-17= Hamilton Rating Scale for Depression (17-items); HDRS= Hamilton Depression Rating Scale; ICD-10= International Statistical Classification of Diseases and Related Health Problems- 10th Revision; IPSRT=Interpersonal and Social Rhythm Therapy; LIFE-RIFT= Longitudinal Interval Follow-up Evaluation-Range of Impaired Functioning Tool; MADRS=Montgomery-Asberg Depression Rating Scale; NOS=not otherwise specified; NR=not reported; PMID=PubMed Identification Number; RCT=randomized controlled trial; WHO-QOL-bref= World Health Organization Quality of Life–short version; YMRS = Young Mania Rating Scale
Appendix Table P2Summary risk of bias assessments: STEP-BD study and other psychosocial interventions
| Study Funder PMID | Overall Risk of Bias Assessment | Rationale |
|---|---|---|
| Depp, 20151 Government 25479050 | Low | No significant suspected biases. |
| Faurholt-Jepsen, 20152 Government and Non-Government 26220802 | Low | No significant suspected biases. |
| Deckersbach 20143 Miklowitz 20074 Miklowitz 2007b5 Government and Non-Government 24077657 17728418 17404119 | High Moderate High | Suspected bias due to attrition rate of 48%. Part of analysis only includes subset of subjects from total study population. |
Abbreviations: PMID=PubMed Identification Number
Appendix Table P3Outcomes summary: STEP-BD Study and other psychosocial interventions
| Study PMID | Responder/Remitter | Symptom | Function | Other | AE |
|---|---|---|---|---|---|
| Depp, 20151 25479050 | NR | Depression 6 months, MADRS NS ES=0.02; p=0.05 Mania 6 months, YMRS NS ES=−0.09;p=0.26 | NR | NR | NR |
| Faurholt-Jepsen, 20152 26220802 | NR | Depression 6 months, HAMD-17 NS Adjusted Difference: 0.96 (95% CI −4.36, 6.28); p=0.72 Mania 6 months, YMRS NS Adjusted Difference= −0.34 (95% CI −1.14, 0.47); p=0.41 | Global Function 6 months, FAST NS Adjusted Difference= 0.96 (95% CI −4.36, 6.28); p=0.72 Quality of Life NS 6 months, WHO-QOL-bref Adjusted Difference= 1.24 (95% CI −5.18, 2.70); p=0.54 | NR | NR |
| Deckersbach 20143 24077657 Miklowitz 20074 17728418 Miklowitz 2007b5 17404119 | Number Recovered 1 year Favors intensive psychosocial intervention HR 1.47; p = .01 Family Therapy: HR 1.87 IPSRT: HR 1.48 CBT: HR 1.34 | NR | Functional Impairement 9 months, LIFT-RIFT Favors intensive psychosocial intervention, p=0.04 Mean Difference (SD) Family Therapy: −3.17 (3.06) IPSRT: −1.63 (4.35) CBT: −1.05 (4.77) Collaborative Care: −0.94 (3.5) | NR | NR |
Abbreviations: AE=Adverse Events; CBT= Cognitive Behavioral Theraphy; CI=Confidence Interval; ES=Effect Size; FAST= Functioning Assessment Short Test; HAMD-17= Hamilton Rating Scale for Depression (17-items); HR=Hazard Ratio; LIFE-RIFT= Longitudinal Interval Follow-up Evaluation-Range of Impaired Functioning Tool; MADRS=Montgomery-Asberg Depression Rating Scale; IPSRT= Interpersonal and Social Rhythm Therapy; NR=not reported; NS=not significant; PMID=PubMed Identification Number; SD=standard deviation; WHO-QOL-bref= World Health Organization Quality of Life–short version; YMRS = Young Mania Rating Scale
Appendix Table P4Summary of strength of evidence: other psychosocial interventions, self-management interventions
| Outcome | Timing | # Studies/Design (n analyzed) | Finding or Summary Statistic | Study Limitations | Consistency | Directness | Precision | Overall Grade/Conclusion |
|---|---|---|---|---|---|---|---|---|
| Relapse | NR | - | - | - | - | - | - | - |
| Depression | 6 months | 2 RCTs (n=182) | No difference between groups in MADRS at 6 months. | Low | Consistent | Direct | Imprecise | Insufficient |
| Mania | 6 months | 2 RCTs (n=182) | No difference between groups in YMRS at 6 months. | Low | Consistent | Direct | Imprecise | Insufficient |
| Global Function | 6 months | 1 RCT (n=78) | No difference between groups at 6 months. FAST Adjusted Difference= 0.96 (95% CI −4.36, 6.28); p=0.72 | Low | Unclear | Direct | Imprecise | Insufficient |
| Other Measures of Function | 6 months | 1 RCT (n=78) | No difference between groups at 6 months. WHO-QOL-bref Adjusted Difference= 1.24 (95% CI −5.18, 2.70); p=0.54 | Low | Unclear | Direct | Imprecise | Insufficient |
Abbreviations: CI=Confidence Interval; FAST= Functioning Assessment Short Test; MADRS=Montgomery-Asberg Depression Rating Scale; NR=not reported; RCT=randomized controlled trial; WHO-QOL-bref= World Health Organization Quality of Life–short version; YMRS = Young Mania Rating Scale
Appendix Table P5Characteristics of eligible studies: somatic therapy
| 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 |
|---|---|---|---|---|---|---|
| Fitzgerald, 20166 RCT Australia Government Medium 27016659 | N = 46 Age 46 (33-59) Female 57% Race NR BP I 63% BP II 37% Outpatient | Depression; Individuals with BP I or II (DSM-IV) with persistent depressive symptoms (HAM-D > 20) who failed to respond to at least two courses of anti-depressants for at least 6 weeks in current episode. No increase or initiation of new treatment in the four weeks prior to rTMS. Labs/Other Conditions; Neurological Disorder | Repetitive transcranial magnetic stimulation -20 rTMS sessions for four weeks | Sham stimulation -20 sham sessions for four weeks | 4 weeks | HAM-D Response Remission (Not Defined) Withdrawal 13% |
Abbreviations: BP=bipolar disorder; CBT= Cognitive Behavioral Therapy; DSM=Diagnostic and Statistical Manual of Mental Disorders; FAST= Functioning Assessment Short Test; HAMD-17= Hamilton Rating Scale for Depression (17-items); HDRS= Hamilton Depression Rating Scale; ICD-10= International Statistical Classification of Diseases and Related Health Problems- 10th Revision; IPSRT=Interpersonal and Social Rhythm Therapy; LIFE-RIFT= Longitudinal Interval Follow-up Evaluation-Range of Impaired Functioning Tool; MADRS=Montgomery-Asberg Depression Rating Scale; NOS=not otherwise specified; NR=not reported; PMID=PubMed Identification Number; RCT=randomized controlled trial; WHO-QOL-bref= World Health Organization Quality of Life–short version; YMRS = Young Mania Rating Scale
Appendix Table P6Summary risk of bias assessments: somatic therapy
| Study Funder PMID | Overall Risk of Bias Assessment | Rationale |
|---|---|---|
| Fitzgerald, 20166 Government 27016659 | Moderate | Suspected bias due to unclear reporting of attrition/loss to followup. |
Abbreviations: PMID=PubMed Identification Number
Appendix Table P7Outcomes summary: somatic therapy
| Study PMID | Responder/Remitter | Symptom | Function | Other | AE |
|---|---|---|---|---|---|
| Fitzgerald, 20166 27016659 | Response 4 weeks NS; p<0.05 rTMS=3 Sham=1 Remission 4 weeks NS; p<0.05 rTMS=2 Sham=0 | Depression* 4 weeks, HAM-D NS ES=−0.04 (95% CI −0.62, 0.54) | NR | NR | NR |
Abbreviations: AE=Adverse Events; CI=Confidence Interval; ES=Effect Size;
References for Appendix P
- 1.
- Depp CA, Ceglowski J, Wang VC, et al Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial. Journal of Affective Disorders. 2015 Mar 15;174:23–30. doi: http://dx
.doi.org/10 .1016/j.jad.2014.10.053. PMID: 25479050. [PMC free article: PMC4339469] [PubMed: 25479050] - 2.
- Faurholt-Jepsen M, Frost M, Ritz C, et al Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial. Psychological Medicine. 2015 Oct;45(13):2691–704. doi: http://dx
.doi.org/10 .1017/S0033291715000410. PMID: 26220802. [PubMed: 26220802] - 3.
- Deckersbach T, Peters AT, Sylvia L, et al Do comorbid anxiety disorders moderate the effects of psychotherapy for bipolar disorder? Results from STEP-BD. American Journal of Psychiatry. 2014 Feb;171(2):178–86. doi: http://dx
.doi.org/10 .1176/appi.ajp.2013.13020225. PMID: 24077657. [PMC free article: PMC3946300] [PubMed: 24077657] - 4.
- Miklowitz DJ, Otto MW, Frank E, et al Intensive psychosocial intervention enhances functioning in patients with bipolar depression: results from a 9-month randomized controlled trial. American Journal of Psychiatry. 2007 Sep;164(9):1340–7. PMID: 17728418. [PMC free article: PMC3579578] [PubMed: 17728418]
- 5.
- Miklowitz DJ, Otto MW, Frank E, et al Psychosocial treatments for bipolar depression: a 1-year randomized trial from the Systematic Treatment Enhancement Program. Archives of General Psychiatry. 2007 Apr;64(4):419–26. PMID: 17404119. [PMC free article: PMC3579612] [PubMed: 17404119]
- 6.
- Fitzgerald PB, Hoy KE, Elliot D, et al A negative double-blind controlled trial of sequential bilateral rTMS in the treatment of bipolar depression. Journal of Affective Disorders. 2016 01 Jul;198:158–62. doi: http://dx
.doi.org/10 .1016/j.jad.2016.03.052. PMID: 27016659 PMID/609157504 Embase. [PubMed: 27016659]
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