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

Phase 1

Completed

• Conditions: Depression
• Interventions: Behavioral: Interpersonal Psychotherapy (IPT); Behavioral: Individual Psychotherapy

• Registration Number: NCT00257400
• Lead Sponsor: University of Rochester

Brief Summary

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

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 Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-11-21
• Study First Posted: 2005-11-22
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-31
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpersonal Psychotherapy (IPT)	Interpersonal Psychotherapy (IPT)	Interpersonal Psychotherapy
Individual Psychotherapy	Individual Psychotherapy	Individual Psychotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States