Evidence-based treatments for depression have rarely been studied in community settings where low income and ethnic minority patients receive care. Among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties.
The aim of the proposed randomized controlled trial (RCT), based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS). IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. Substantial pilot data providing preliminary support for IPTTCS and supporting the feasibility of the proposed RCT have been collected during the P.l.'s NIMH-K23 Career Development Award. An ongoing pilot RCT of IPT-TCS has demonstrated high rates of patient recruitment and acceptance of randomization. The proposed RCT (n=180) will compare IPT-TCS to treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. A hybrid efficacy-effectiveness design will be used. Urn randomization procedures will balance groups with respect to medication status;active post-traumatic stress disorder (PTSD);active anxiety disorder other than PTSD;fully-remitted substance use disorders;and, borderline personality disorder. Medication dosage and adherence, medication management visits, and case management visits will not be controlled by design, but will be controlled statistically in secondary analyses. We hypothesize that IPT-TCS will be more effective than TAU in reducing depression at 32-weeks after treatment assignment. Improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. To monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. The proposed research is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center. The next stage of our research program will be directed at transporting IPT-TCS and comparison therapies into community agencies.
