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Women's Depression Treatment Study

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy-Trauma in Community Settings
Treatment as Usual
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpersonal Psychotherapy

Individual Psychotherapy

Arm Description

Interpersonal Psychotherapy, 16 individual sessions within 32 weeks

Individual Psychotherapy, 16 individual sessions within 32 weeks

Outcomes

Primary Outcome Measures

Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module

Secondary Outcome Measures

Beck Depression Inventory
Hamilton Rating Scale for Depression

Full Information

First Posted
February 12, 2009
Last Updated
January 8, 2014
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00843700
Brief Title
Women's Depression Treatment Study
Official Title
Effectiveness of IPT Adapted for Depressed Women With Trauma Histories in a Community Mental Health Center
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
Interpersonal Psychotherapy, 16 individual sessions within 32 weeks
Arm Title
Individual Psychotherapy
Arm Type
Active Comparator
Arm Description
Individual Psychotherapy, 16 individual sessions within 32 weeks
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy-Trauma in Community Settings
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Individual psychotherapy following usual care practice in a community mental health center.
Primary Outcome Measure Information:
Title
Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
20 months
Title
Hamilton Rating Scale for Depression
Time Frame
20 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy L Talbot, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Talbot NL, Gamble SA. IPT for women with trauma histories in community mental health care. Journal of Contemporary Psychotherapy 38(1): 35-44, 2008.
Results Reference
background
PubMed Identifier
23499057
Citation
Lestrade KN, Talbot NL, Ward EA, Cort NA. High-risk sexual behaviors among depressed Black women with histories of intrafamilial and extrafamilial childhood sexual abuse. Child Abuse Negl. 2013 Jun;37(6):400-3. doi: 10.1016/j.chiabu.2013.01.007. Epub 2013 Mar 14.
Results Reference
result
PubMed Identifier
35653744
Citation
Glanton Holzhauer C, Duberstein P, Ward E, Talbot N. Reducing posttraumatic stress disorder symptom severity among depressed women with childhood sexual abuse histories in interpersonal psychotherapy-trauma: The role of improved social functioning. Psychol Trauma. 2022 Jun 2. doi: 10.1037/tra0001293. Online ahead of print.
Results Reference
derived
PubMed Identifier
22296967
Citation
Cankaya B, Talbot NL, Ward EA, Duberstein PR. Parental sexual abuse and suicidal behaviour among women with major depressive disorder. Can J Psychiatry. 2012 Jan;57(1):45-51. doi: 10.1177/070674371205700108.
Results Reference
derived

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Women's Depression Treatment Study

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