Women's Depression Treatment Study

University of Rochester

Status and phase: Completed; Phase 2

Conditions: Depression

Treatments: Behavioral: Treatment as Usual; Behavioral: Interpersonal Psychotherapy-Trauma in Community Settings

Study type: Interventional

Funder types: Other

Identifiers

NCT00843700

1R01MH076928 (U.S. NIH Grant/Contract)

RSRB00020535

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Interpersonal Psychotherapy

Experimental group

Description:

Interpersonal Psychotherapy, 16 individual sessions within 32 weeks

Treatment:

Behavioral: Interpersonal Psychotherapy-Trauma in Community Settings

Individual Psychotherapy

Active Comparator group

Description:

Individual Psychotherapy, 16 individual sessions within 32 weeks

Treatment:

Behavioral: Treatment as Usual