Women's Depression Treatment Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nancy Talbot, University of Rochester
ClinicalTrials.gov Identifier:
NCT00843700
First received: February 12, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Depression
Behavioral: Interpersonal Psychotherapy-Trauma in Community Settings
Behavioral: Treatment as Usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of IPT Adapted for Depressed Women With Trauma Histories in a Community Mental Health Center

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module [ Time Frame: 20 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Depression [ Time Frame: 20 months ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: September 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal Psychotherapy
Interpersonal Psychotherapy, 16 individual sessions within 32 weeks
Behavioral: Interpersonal Psychotherapy-Trauma in Community Settings
Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.
Active Comparator: Individual Psychotherapy
Individual Psychotherapy, 16 individual sessions within 32 weeks
Behavioral: Treatment as Usual
Individual psychotherapy following usual care practice in a community mental health center.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843700

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Nancy L Talbot, Ph.D. University of Rochester
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Talbot, Associate Professor, Department of Psychiatry, University of Rochester
ClinicalTrials.gov Identifier: NCT00843700     History of Changes
Other Study ID Numbers: RSRB00020535, 1R01MH076928
Study First Received: February 12, 2009
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014