Comparison of Two Psychotherapy Treatments for Depressed Women With a History of Sexual Abuse

December 31, 2013 updated by: University of Rochester

Interpersonal Psychotherapy for Depressed Women With Sexual Abuse Histories

This study will compare the effectiveness of individual versus interpersonal psychotherapy in treating depressed women with a history of sexual abuse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is a common but serious mental disorder that affects millions of people each year. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affecting people's sleep patterns, concentration, and energy levels. Women with a history of abuse are at an increased risk for developing symptoms of depression. However, treatments such as interpersonal psychotherapy and individual psychotherapy have been known to reduce symptoms of depression. This study will compare the effectiveness of individual and interpersonal psychotherapy in improving depressive symptoms and daily functioning in depressed women with a history of sexual abuse.

Participants in this study will undergo a two-part screening interview at the Strong Adult Ambulatory Clinic. This screening will include both written questionnaires and face-to-face interviews regarding any experiences of sexual or physical abuse; suicidal thoughts; family relationships; and current attitudes, thoughts, or feelings. Participants who meet all criteria will then be randomly assigned to receive one of two treatments: interpersonal psychotherapy or individual psychotherapy, which is considered usual care. All treatment sessions will be held at the Strong Adult Ambulatory Clinic. Participants assigned to receive interpersonal psychotherapy will attend weekly 50-minute sessions with a therapist. Interpersonal psychotherapy will focus on current interpersonal stressors in daily life, such as difficulties in close relationships or at work. Treatment will also help participants examine the relationship between their mood changes and interpersonal problems. Participants assigned to receive individual psychotherapy will undergo cognitive-behavioral therapy, supportive counseling, or a combination of the two. Participants will work with their therapists to decide upon a treatment plan designed to help changes in mood and other difficulties in daily life. The number and length of treatment sessions for this group will be determined on an individual basis. For all participants, evaluations consisting of questionnaires similar to those from the initial screening will be completed at mid-treatment, post-treatment, and 3 months after treatment.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Meets DSM-IV criteria for 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:

  • Meets DSM-IV criteria for major depression with psychotic features, bipolar disorder, schizophrenia, or mental retardation
  • Active alcohol or substance abuse within 3 months of study entry date

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interpersonal Psychotherapy (IPT)
Interpersonal Psychotherapy
Behavioral: Interpersonal Psychotherapy (IPT)
Interpersonal Psychotherapy
Active Comparator: Individual Psychotherapy
Behavioral: Individual Psychotherapy
Individual Psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Rating Scale for Depression
Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36
Measured at pre-treatment and Weeks 10, 24, and 36
Beck Depression Inventory
Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36
Measured at pre-treatment and Weeks 10, 24, and 36
Structured Clinical Interview for DSM-IV Diagnoses
Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36
Measured at pre-treatment and Weeks 10, 24, and 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Social Adjustment Scale
Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36
Measured at pre-treatment and Weeks 10, 24, and 36
Medical Outcomes Survey
Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36
Measured at pre-treatment and Weeks 10, 24, and 36
Post Traumatic Stress Disorder (PTSD) Symptom Scale
Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36
Measured at pre-treatment and Weeks 10, 24, and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Nancy L. Talbot, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

December 31, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23MH064528 (U.S. NIH Grant/Contract)
  • DSIR 8K-RTAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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