Women's Depression Treatment Study

Phase 2

Completed

• Conditions: Depression
• Interventions: Behavioral: Interpersonal Psychotherapy-Trauma in Community Settings; Behavioral: Treatment as Usual

• Registration Number: NCT00843700
• Lead Sponsor: University of Rochester

Brief Summary

The aim of the Women's Depression Treatment Study, based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.

Detailed Description

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 this 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. This trial (n=180) will compare IPT-TCS to active treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. 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. This trial is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

• Age 18 or older
• Current Major Depression
• History of sexual abuse prior to age 18

Exclusion Criteria

• Bipolar disorder
• Psychosis or schizophrenia
• Active alcohol or substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpersonal Psychotherapy	Interpersonal Psychotherapy-Trauma in Community Settings	Interpersonal Psychotherapy, 16 individual sessions within 32 weeks
Individual Psychotherapy	Treatment as Usual	Individual Psychotherapy, 16 individual sessions within 32 weeks

Primary Outcome Measures

Name	Time	Method
Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module	20 months

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory	20 months
Hamilton Rating Scale for Depression	20 months

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States