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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00257400
First received: November 21, 2005
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Interpersonal Psychotherapy (IPT)
Behavioral: Individual Psychotherapy
Phase 1
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: Interpersonal Psychotherapy for Depressed Women With Sexual Abuse Histories

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: 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 ]
  • Structured Clinical Interview for DSM-IV Diagnoses [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]

Secondary Outcome Measures:
  • Social Adjustment Scale [ Time Frame: 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 ]
  • Post Traumatic Stress Disorder (PTSD) Symptom Scale [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]

Enrollment: 70
Study Start Date: May 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal Psychotherapy (IPT)
Interpersonal Psychotherapy
Behavioral: Interpersonal Psychotherapy (IPT)
Interpersonal Psychotherapy
Active Comparator: Individual Psychotherapy
Individual Psychotherapy
Behavioral: Individual Psychotherapy
Individual Psychotherapy

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.

  Eligibility

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

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
  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: NCT00257400

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, PhD University of Rochester
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00257400     History of Changes
Other Study ID Numbers: K23 MH064528, K23MH064528, DSIR 8K-RTAT
Study First Received: November 21, 2005
Last Updated: December 31, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
major depressive disorder
psychotherapy
childhood sexual abuse
trauma

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

ClinicalTrials.gov processed this record on July 26, 2014