Women's Depression Treatment Study

NCT ID: NCT00843700

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interpersonal Psychotherapy

Interpersonal Psychotherapy, 16 individual sessions within 32 weeks

Group Type: EXPERIMENTAL

Interpersonal Psychotherapy-Trauma in Community Settings

Intervention Type: BEHAVIORAL

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.

Individual Psychotherapy

Individual Psychotherapy, 16 individual sessions within 32 weeks

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Individual psychotherapy following usual care practice in a community mental health center.

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

Individual psychotherapy following usual care practice in a community mental health center.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Nancy Talbot

Associate Professor, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy L Talbot, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

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

Reference Type: BACKGROUND

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.

Reference Type: RESULT

PMID: 23499057 (View on PubMed)

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. 2024 Apr;16(Suppl 1):S285-S292. doi: 10.1037/tra0001293. Epub 2022 Jun 2.

Reference Type: DERIVED

PMID: 35653744 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22296967 (View on PubMed)

Other Identifiers

1R01MH076928

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RSRB00020535

Identifier Type: -

Identifier Source: org_study_id