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 professionalcare 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.
RCT Entities:
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.
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