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Pilot Randomized Controlled Trial of Interpersonal Counseling for Subsyndromal Depression Following Miscarriage

Richard Neugebauer, PhD; Jennie Kline, PhD; John C. Markowitz, MD; Kathryn L. Bleiberg, PhD; Laxmi Baxi, MD; Mark A. Rosing, MD, MPH; Bruce Levin, PhD; and Jessica Keith, MA

Published: August 15, 2006

Article Abstract

Objective: Miscarriage, which occurs in 10% to20% of clinically recognized pregnancies, is associated with anincreased risk for subsyndromal depression. We examined whetherInterpersonal Counseling (IPC) was superior to treatment as usual(TAU) in reducing subsyndromal depression among miscarrying womenand, secondarily, superior to TAU in improving role functioning.

Method: Nineteen of 20 eligible womenparticipated in a randomized controlled trial of 1 to 6 weeklytelephone sessions of IPC versus TAU, which consisted of whateverlay counseling or professional care women sought on their owninitiative, from October 2001 to April 2002. The 2 trial armswere compared on mean within-subject change in Hamilton RatingScale for Depression-17-item (HAM-D-17) scores and in rolefunctioning scale scores (a 5-item modification of the 36-itemMedical Outcomes Study questionnaire) from baseline topost-intervention.

Results: In the primary intent-to-treatanalysis, 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 were11.6 (SD ± 8.2) and 12.9 (SD ± 8.3). The mean within-subjectdecline in HAM-D-17 scores was significantly greater in the IPC(6.4) than in the TAU (1.9) arm (difference in meanwithin-subject score decline, adjusted for design features,baseline HAM-D-17 scores and for baseline ethnic imbalancebetween study arms, 6.2 [95% CI = 0.4 to 12.0]). In a subordinatecompleters’ analysis (N = 15), the corresponding mean decline anddifference in adjusted mean decline were 8.0, 2.4, and 6.7 (95%CI = 0.4 to 13.1), respectively. Treatment was unrelated toimproved role functioning.

Conclusion: The efficacy oftelephone-administered IPC for subsyndromal depression aftermiscarriage warrants testing in a full-scale randomizedcontrolled trial.

Volume: 67

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