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Results of a 2-Year Randomized Trial

David J. Miklowitz, PhD; David A. Axelson, MD; Boris Birmaher, MD; Elizabeth L. George, PhD; Dawn O. Taylor, PhD; Christopher D. Schneck, MD; Carol A. Beresford, MD; L. Miriam Dickinson, PhD; W. Edward Craighead, PhD; David A. Brent, MD

Arch Gen Psychiatry. 2008;65(9):1053-1061.

Context  Family interventions have been found to hasten episode recovery and delay recurrences among adults with bipolar disorder.

Objective  To examine the benefits of family-focused treatment for adolescents (FFT-A) and pharmacotherapy in the 2-year course of adolescent bipolar disorder.

Design  Two-site outpatient randomized controlled trial with 2-year follow-up.

Patients  A referred sample of 58 adolescents (mean [SD] age, 14.5 [1.6] years) with bipolar I (n = 38), II (n = 6), or not otherwise specified disorder (n = 14) with a mood episode in the prior 3 months.

Interventions  Patients were randomly assigned to FFT-A and protocol pharmacotherapy (n = 30) or enhanced care (EC) and protocol pharmacotherapy (n = 28). The FFT-A consisted of 21 sessions in 9 months of psychoeducation, communication training, and problem-solving skills training. The EC consisted of 3 family sessions focused on relapse prevention.

Main Outcome Measures  Independent "blind" evaluators assessed patients every 3 to 6 months for 2 years. Outcomes included time to recovery from the index episode, time to recurrence, weeks in episode or remission, and mood symptom severity scores.

Results  Analyses were by intent to treat. Rates of 2-year study completion did not differ across the FFT-A (60.0%) and EC conditions (64.3%). Although there were no group differences in rates of recovery from the index episode, patients in FFT-A recovered from their baseline depressive symptoms faster than patients in EC (hazard ratio, 1.85; 95% confidence interval, 1.04-3.29; P = .04). The groups did not differ in time to recurrence of depression or mania, but patients in FFT-A spent fewer weeks in depressive episodes and had a more favorable trajectory of depression symptoms for 2 years.

Conclusions  Family-focused therapy is effective in combination with pharmacotherapy in stabilizing bipolar depressive symptoms among adolescents. To establish full recovery, FFT-A may need to be supplemented with systematic care interventions effective for mania symptoms.

Trial Registration  clinicaltrials.gov Identifier NCT00571402.

Author Affiliations: Department of Psychology, University of Colorado, Boulder (Drs Miklowitz, George, Taylor, and Craighead); Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (Drs Axelson, Birmaher, and Brent); and Department of Psychiatry, University of Colorado Health Sciences Center, Denver (Drs Miklowitz, Schneck, Beresford, and Dickinson).

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