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Clinical Trial Summary

The purpose of this study is to compare women randomized to Interpersonal Psychotherapy (IPT) and those randomized to usual care in a community mental health center. The main outcome is depression, and it will be assessed in several ways. Other outcome measures will provide vital information about social, psychological, and health functioning. Key patient-level variables that predict outcomes will be identified. The acceptability of IPT will also be examined.


Clinical Trial Description

Despite the vulnerability of sexually abused women to depression, treatments for this patient population have rarely been examined in empirically rigorous and systematic research. This study begins a program of research on interventions for depressed women with histories of childhood sexual abuse and other lifetime traumas. Interpersonal psychotherapy (IPT), a well-described and efficacious treatment that focuses on the current interpersonal difficulties of depressed patients, will be implemented and examined in this preliminary investigation of IPT for women who suffer from major depression, who have histories of childhood sexual abuse, and who are being treated in a community mental health center. This study will compare women randomized to IPT and those randomized to usual care. The main outcome is depression. Other outcome measures will provide vital information about social, psychological, and health functioning. Key patient-level variables that predict outcomes will be identified. The acceptability of IPT will also be examined.

All participants will be women who are seeking treatment in our community mental health center (Strong Behavioral Health, Adult Ambulatory Clinic). If they meet preliminary inclusion criteria during the standard adult ambulatory intake interview, they will be referred to study personnel for recruitment, informed consent, and screening. Inclusion criteria are current major depression and a history of childhood sexual abuse. Exclusion criteria include major depression with psychotic features; lifetime history of schizophrenia, bipolar disorder, or mental retardation; and active substance abuse or psychosis. Female patients (n=70) who are 18 or older, who meet criteria for major depression and childhood sexual abuse will be randomly assigned to 16-weeks of interpersonal psychotherapy (IPT) or usual care (UC). Assessments will be conducted at pretreatment, 10-weeks (mid-treatment), 24-weeks (post-treatment), and at 3-month follow up (36-weeks). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00843674
Study type Interventional
Source University of Rochester
Contact
Status Completed
Phase Phase 2
Start date September 2002
Completion date August 2007

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