NCT00843700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for phase_2 depression

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

4.5 years

First QC Date

February 12, 2009

Last Update Submit

January 8, 2014

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

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

    20 months

Secondary Outcomes (2)

  • Beck Depression Inventory

    20 months

  • Hamilton Rating Scale for Depression

    20 months

Study Arms (2)

Interpersonal Psychotherapy

EXPERIMENTAL

Interpersonal Psychotherapy, 16 individual sessions within 32 weeks

Behavioral: Interpersonal Psychotherapy-Trauma in Community Settings

Individual Psychotherapy

ACTIVE COMPARATOR

Individual Psychotherapy, 16 individual sessions within 32 weeks

Behavioral: Treatment as Usual

Interventions

Interpersonal Psychotherapy-Trauma in Community SettingsBEHAVIORAL

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.

Interpersonal Psychotherapy
Treatment as UsualBEHAVIORAL

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

Individual Psychotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Current Major Depression
  • History of sexual abuse prior to age 18

You may not qualify if:

  • Bipolar disorder
  • Psychosis or schizophrenia
  • Active alcohol or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (4)

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

    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.

    PMID: 23499057RESULT

  • 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.

    PMID: 35653744DERIVED

  • 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.

    PMID: 22296967DERIVED

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Nancy L Talbot, Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychiatry

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

September 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(1)