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A 1-Year Randomized Trial From the Systematic Treatment Enhancement Program

David J. Miklowitz, PhD; Michael W. Otto, PhD; Ellen Frank, PhD; Noreen A. Reilly-Harrington, PhD; Stephen R. Wisniewski, PhD; Jane N. Kogan, PhD; Andrew A. Nierenberg, MD; Joseph R. Calabrese, MD; Lauren B. Marangell, MD; Laszlo Gyulai, MD; Mako Araga, MS; Jodi M. Gonzalez, PhD; Edwin R. Shirley, PhD; Michael E. Thase, MD; Gary S. Sachs, MD

Arch Gen Psychiatry. 2007;64(4):419-426.

Context  Psychosocial interventions have been shown to enhance pharmacotherapy outcomes in bipolar disorder.

Objective  To examine the benefits of 4 disorder-specific psychotherapies in conjunction with pharmacotherapy on time to recovery and the likelihood of remaining well after an episode of bipolar depression.

Design  Randomized controlled trial.

Setting  Fifteen clinics affiliated with the Systematic Treatment Enhancement Program for Bipolar Disorder.

Patients  A total of 293 referred outpatients with bipolar I or II disorder and depression treated with protocol pharmacotherapy were randomly assigned to intensive psychotherapy (n = 163) or collaborative care (n = 130), a brief psychoeducational intervention.

Interventions  Intensive psychotherapy was given weekly and biweekly for up to 30 sessions in 9 months according to protocols for family-focused therapy, interpersonal and social rhythm therapy, and cognitive behavior therapy. Collaborative care consisted of 3 sessions in 6 weeks.

Main Outcome Measures  Outcome assessments were performed by psychiatrists at each pharmacotherapy visit. Primary outcomes included time to recovery and the proportion of patients classified as well during each of 12 study months.

Results  All analyses were by intention to treat. Rates of attrition did not differ across the intensive psychotherapy (35.6%) and collaborative care (30.8%) conditions. Patients receiving intensive psychotherapy had significantly higher year-end recovery rates (64.4% vs 51.5%) and shorter times to recovery than patients in collaborative care (hazard ratio, 1.47; 95% confidence interval, 1.08-2.00; P = .01). Patients in intensive psychotherapy were 1.58 times (95% confidence interval, 1.17-2.13) more likely to be clinically well during any study month than those in collaborative care (P = .003). No statistically significant differences were observed in the outcomes of the 3 intensive psychotherapies.

Conclusions  Intensive psychosocial treatment as an adjunct to pharmacotherapy was more beneficial than brief treatment in enhancing stabilization from bipolar depression. Future studies should compare the cost-effectiveness of models of psychotherapy for bipolar disorder.

Trial Registration  clinicaltrials.gov Identifier: NCT00012558

Author Affiliations: Departments of Psychology and Psychiatry, University of Colorado, Boulder (Dr Miklowitz); Department of Psychology, Boston University, Boston, Mass (Dr Otto); Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh, Pa (Drs Frank and Thase); Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (Drs Reilly-Harrington, Nierenberg, and Sachs); Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh (Dr Wisniewski and Ms Araga); Department of Psychiatry, University of Pittsburgh School of Medicine and Community Care Behavioral Health Organization (Dr Kogan); Department of Psychiatry, Case Western Reserve University School of Medicine/University Hospitals of Cleveland, Cleveland, Ohio (Drs Calabrese and Shirley); Menninger Department of Psychiatry, Baylor College of Medicine, and VISN 16 Mental Illness Research, Education, and Clinical Center, Department of Veterans Affairs, Houston, Tex (Dr Marangell); Department of Psychiatry, University of Pennsylvania, Philadelphia (Dr Gyulai); and Department of Psychiatry, University of Texas Health Science Center, San Antonio (Dr Gonzalez).

RELATED LETTERS

Is Psychosocial Management Effective?
Sahoo Saddichha and Devvarta Kumar
Arch Gen Psychiatry. 2007;64(12):1451.
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Is Psychosocial Management Effective?—Reply
David J. Miklowitz, Michael W. Otto, Ellen Frank, Noreen A. Reilly-Harrington, Stephen R. Wisniewski, Jane N. Kogan, Andrew A. Nierenberg, Joseph R. Calabrese, Lauren B. Marangell, Laszlo Gyulai, Mako Araga, Jodi M. Gonzalez, Edwin R. Shirley, Michael E. Thase, and Gary S. Sachs
Arch Gen Psychiatry. 2007;64(12):1452-1453.
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