Women's Depression Treatment Study

Effectiveness of IPT Adapted for Depressed Women With Trauma Histories in a Community Mental Health Center

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Interpersonal Psychotherapy-Trauma in Community Settings; Behavioral: Treatment as Usual

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 Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module	20 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Beck Depression Inventory	20 months
Hamilton Rating Scale for Depression	20 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Nancy L Talbot, Ph.D., University of Rochester

Publications and helpful links

General Publications

• Talbot NL, Gamble SA. IPT for women with trauma histories in community mental health care. Journal of Contemporary Psychotherapy 38(1): 35-44, 2008.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 12, 2009
• First Submitted That Met QC Criteria: February 12, 2009
• First Posted (Estimate): February 13, 2009

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: RSRB00020535; 1R01MH076928 (U.S. NIH Grant/Contract)