Psychotherapy for Depressed Women With Abuse Histories

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00843674
First received: February 12, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

The purpose of this study is to compare women randomized to Interpersonal Psychotherapy (IPT) and those randomized to usual care in a community mental health center. The main outcome is depression, and it will be assessed in several ways. Other outcome measures will provide vital information about social, psychological, and health functioning. Key patient-level variables that predict outcomes will be identified. The acceptability of IPT will also be examined.


Condition Intervention Phase
Depression
Major Depressive Disorder
Behavioral: Interpersonal Psychotherapy
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: Psychotherapy for Depressed Women With Abuse Histories

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression; Beck Depression Inventory-II; Structured Clinical Interview for DSM-IV Diagnoses [ Time Frame: The primary outcome variable is depression and is measured at baseline (pretest), midtreatment (10-weeks), post-treatment (24-weeks), and follow-up (36-weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Social Adjustment Scale Medical Outcomes Survey; Symptom Checklist-90; PTSD Symptom Scale [ Time Frame: Seconday outcome variables include social functioning, health functioning, and psychological functioning. These secondary outcomes are measured at baseline (pretest), midtreatment (10-weeks), post-treatment (24-weeks), and follow-up (36-weeks) ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: September 2002
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Interpersonal Psychotherapy
Behavioral: Interpersonal Psychotherapy
Active Comparator: 2
Treatment as usual
Behavioral: Treatment as usual

Detailed Description:

Despite the vulnerability of sexually abused women to depression, treatments for this patient population have rarely been examined in empirically rigorous and systematic research. This study begins a program of research on interventions for depressed women with histories of childhood sexual abuse and other lifetime traumas. Interpersonal psychotherapy (IPT), a well-described and efficacious treatment that focuses on the current interpersonal difficulties of depressed patients, will be implemented and examined in this preliminary investigation of IPT for women who suffer from major depression, who have histories of childhood sexual abuse, and who are being treated in a community mental health center. This study will compare women randomized to IPT and those randomized to usual care. The main outcome is depression. Other outcome measures will provide vital information about social, psychological, and health functioning. Key patient-level variables that predict outcomes will be identified. The acceptability of IPT will also be examined.

All participants will be women who are seeking treatment in our community mental health center (Strong Behavioral Health, Adult Ambulatory Clinic). If they meet preliminary inclusion criteria during the standard adult ambulatory intake interview, they will be referred to study personnel for recruitment, informed consent, and screening. Inclusion criteria are current major depression and a history of childhood sexual abuse. Exclusion criteria include major depression with psychotic features; lifetime history of schizophrenia, bipolar disorder, or mental retardation; and active substance abuse or psychosis. Female patients (n=70) who are 18 or older, who meet criteria for major depression and childhood sexual abuse will be randomly assigned to 16-weeks of interpersonal psychotherapy (IPT) or usual care (UC). Assessments will be conducted at pretreatment, 10-weeks (mid-treatment), 24-weeks (post-treatment), and at 3-month follow up (36-weeks).

  Eligibility

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

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • Clinical diagnosis of unipolar major depressive disorder
  • History of childhood sexual abuse before the age of 18
  • Seeking outpatient psychotherapy treatment in a community mental health center

Exclusion Criteria:

  • Major depression with psychotic features
  • Bipolar Disorder
  • Lifetime history of schizophrenia
  • Mental retardation
  • Active alcohol or substance abuse within 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843674

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 School of Medicine and Dentistry
  More Information

Publications:
Responsible Party: Nancy L. Talbot, Ph.D., Principal Investigator, University of Rochester School of Medicine and Dentistry
ClinicalTrials.gov Identifier: NCT00843674     History of Changes
Other Study ID Numbers: NCT00257400, K23MH64528
Study First Received: February 12, 2009
Last Updated: February 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
depression
psychotherapy
trauma

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

ClinicalTrials.gov processed this record on July 24, 2014