Family Focused Therapy vs. Crisis Management for Bipolar
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ALTERNATIVE STRATEGIES TO STANDARD MAINTENANCE THERAPY IN BIPOLAR DISORDER
Clinical question: In patients with bipolar disorder, are there alternative strategies to standard maintenance therapy with a mood stabilizer that improve psychosocial outcomes?
See Zaretsky 2004. Evidence Based Mental Health 7(2):49 for another summary.
Introduction: Even when drug regimens are optimized with active medication management by psychiatrists, up to 60% of patients have relapses within 2 years following an acute episode. Recognizing this, in 1996 the NIMH recommended developing adjunctive psychotherapeutic techniques as an important focus for bipolar research. Prien RF, Rush AJ, NIMH workshop report on the treatment of bipolar disorder. Biol Psych. 1996;40:215-220. Family Focused Therapy has been found to reduce the rate of relapse in Schizophrenics. Falloon /RH, Family Management in the Prevention of Morbidity of Schizophrenia. Arch Gen Psych. 1985,42:887-896.
Study: 101 inpatients and outpatients with acute episodes of bipolar disease were randomized to Crisis Management (CM) or Family Focused Therapy (FFT) at a 2:1 ratio because of lack of therapists for FFT. The CM protocol was designed to emulate community care; 2 1-hour sessions were conducted by therapists at the patient's home and within 2 months of study entry. Then crisis meetings were available over the next 9-months PRN. Medication regimens in both arms were physician selected.
FFT involved all available family members in the patient's home. 21 1-hour sessions (12 weekly, 6 biweekly, 3 monthly). It involved a curriculum of psychoeducation, communication enhancement, problem-solving training.
Therapists were trained and tested for interoperative adherence and competence with good results. Assessment was primarily through the Schedule for Affective Disorders and Schizophrenia, Change version. Drug regimens were not regulated by the study, but regimens were assigned an intensity scale of 0-4 based on the number and dose. These ratings did not vary between groups as outset or conclusion.
Results:
Of the 70 patients assigned to CM, 54% were known to have relapsed and 17% were known to have not, 6% were unchanged. Mean survival was 53.2 +/-39. weeks.
Of the 31 patients assigned to FFT, 35% relapsed, 53% survived without relapse and 3% were unchanged. Mean survival was 73.5 +/- 28.8 weeks.
Hazard ratio=0.38 with a 95% CI 0.20-0.75
Other Results:
- On a 1-3 scale, FFT patients had better mean adherence scores: 2.77 +/-0.43 vs CM 2.56 +/- 0.48 P=0.4
- ANOVA suggested adherence had no effect on depression scores, but was closely related to mania scores P<.001.
- A second ANOVA suggested longer treatment periods were associated with lower affective symptom scores, particularly for manic sx. This could not be explained by age, gender, socioecon status, # prior episodes.
Challenges to Validity:
- Physicians in FFT group might have known this and chosen more complex regimens.
- The early termination rate was 23% in the CM group and 10% in the FFT group.
- However the 6mo-2yr dropout rate was 17% and 19%, for the CM and FFT groups.
- Therefore 61 % of CM and 71 % FFT patients were retained. If one assumes the worst, that all dropouts were due to reoccurrences, then the benefit is marginal and not significant.
- CM occurred within 2 months of enrollment; FFT apparently occurred immediately after enrollment. Maybe the benefit is due to EARLY intervention, not length of intervention.
- Outcome evaluators did not provide tx but were aware of which groups patients were in. However their interviews were re-evaluated by secondary blinded raters.
- Medication compliance and symptoms were gathered retrospectively (by patient recall) and w/o verification
Challenges to Applicability:
- Therapy (both types) was in patient homes.
- Study follow up may have made investigators more aware of medication SE. This would allow better pharmacologic control and perhaps encourage physicians to try more aggressive regimen if they knew their patient was going to be in the study.
- Greater frequency of FFT may have made investigators more aware of prodromal symptoms and allowed them to change behavior (such as compliance) before relapse appeared.
- Outcome may decrease over time without renewal of therapy (eg 5, 10 years) the difference may be equivocal.
- Ideal training of therapists with intense oversight by investigators may lead to better results.
Comment: One interesting question is whether the benefit of FFT is frequency of contact (process) or is there an inherent value in the information presented (content). Another study randomized a smaller group (53 total) to 21 sessions of FFT vs 21 sessions of individual therapy. It suggests that FFT ws more effective with 28% relapse and 21 % of re hospitalization after one-year vs 60% and 60% respectively for individual therapy. But they were only followed for one year. Rea MM et al. Family Focused Treatment vs Individual Treatment for Bipolar Disorder. J Consult Clin Pscyhol 2003;71:482-492
This suggests that the benefit of FFT is perhaps not only based on contact and therefore solely due to improved pharmacologic compliance. One important explanation of the benefit of FFT might be to develop a family support system that can recognize symptoms and reinforce compliance. This is supported by several randomized, although small, trials of FFT and Schizophrenia which have found that the benefits of family intervention are independent of medication compliance
Presented by Chris Kenedi, MD
