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Pilot Randomized Controlled Trial of Interpersonal Counseling for Subsyndromal Depression Following Miscarriage
Richard Neugebauer, Ph.D., M.P.H.; Jennie Kline, Ph.D.; John C. Markowitz, M.D.; Kathryn L. Bleiberg, Ph.D.; Laxmi Baxi, M.D.; Mark A. Rosing, M.D., M.P.H.; Bruce Levin, Ph.D.; and Jessica Keith, M.A.
Objective: Miscarriage, which occurs in 10% to 20% of clinically recognized pregnancies, is associated with an increased risk for subsyndromal depression. We examined whether Interpersonal Counseling (IPC) was superior to treatment as usual (TAU) in reducing subsyndromal depression among miscarrying women and, secondarily, superior to TAU in improving role functioning.
Method: Nineteen of 20 eligible women participated in a randomized controlled trial of 1 to 6 weekly telephone sessions of IPC versus TAU, which consisted of whatever lay counseling or professional care women sought on their own initiative, from October 2001 to April 2002. The 2 trial arms were compared on mean within-subject change in Hamilton Rating Scale for Depression-17-item (HAM-D-17) scores and in role functioning scale scores (a 5-item modification of the 36-item Medical Outcomes Study questionnaire) from baseline to post-intervention.
Results: In the primary intent-to-treat analysis, the baseline mean HAM-D-17 scores were 18.0 (SD ± 8.4) and 14.8 (SD ± 6.6) in the IPC (N = 10) and TAU (N = 9) arms, respectively; post-intervention, the corresponding means were 11.6 (SD ± 8.2) and 12.9 (SD ± 8.3). The mean within-subject decline in HAM-D-17 scores was significantly greater in the IPC (6.4) than in the TAU (1.9) arm (difference in mean within-subject score decline, adjusted for design features, baseline HAM-D-17 scores and for baseline ethnic imbalance between study arms, 6.2 [95% CI = 0.4 to 12.0]). In a subordinate completers' analysis (N = 15), the corresponding mean decline and difference in adjusted mean decline were 8.0, 2.4, and 6.7 (95% CI = 0.4 to 13.1), respectively. Treatment was unrelated to improved role functioning.
Conclusion: The efficacy of telephone-administered IPC for subsyndromal depression after miscarriage warrants testing in a full-scale randomized controlled trial.
(J Clin Psychiatry 2006;67:1299-1304)
Received Dec. 25, 2005; accepted April 10, 2006. From the Epidemiology of Developmental Brain Disorders Department, New York State Psychiatric Institute, and the G.H. Sergievsky Center, Columbia University, New York, N.Y. (Drs. Neugebauer and Kline); the Departments of Epidemiology (Dr. Kline), and Biostatistics (Dr. Levin), Mailman School of Public Health, Columbia University, New York, N.Y.; the Department of Psychiatry, Weill Medical College of Cornell University, New York, N.Y. (Drs. Markowitz and Bleiberg); the Department of Psychiatry, College of Physicians and Surgeons, Columbia University, and Personality Studies Unit, New York State Psychiatric Institute, New York, N.Y. (Dr. Markowitz); the Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, N.Y. (Drs. Baxi and Rosing); the Department of Obstetrics and Gynecology, St. Barnabas Medical Center, Bronx, N.Y. (Dr. Rosing); and the Teachers College, Columbia University, New York, N.Y. (Ms. Keith).
This trial was supported by Independent Investigator Award 001395 from the National Alliance for Research on Schizophrenia and Depression, Great Neck, N.Y.; and grant NIH 1 RO3 MH59179-01A1 from the National Institutes of Health, Bethesda, Md.
Dr. Markowitz reports minor royalties from IPT books at Basic Books, American Psychiatric Press. Ms. Keith is a consultant to Pfizer. The other authors report no additional financial or other relationships relevant to the subject matter of this article.
The authors thank Kathleen F. Clougherty, M.S.W., and Judith Rabkin, Ph.D.
Corresponding author and reprints: Richard Neugebauer, Ph.D., M.P.H., Box 53, New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032 (e-mail: RN3@columbia.edu).