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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257400
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : January 3, 2014
National Institute of Mental Health (NIMH)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Interpersonal Psychotherapy (IPT) Behavioral: Individual Psychotherapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interpersonal Psychotherapy for Depressed Women With Sexual Abuse Histories
Study Start Date : May 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Interpersonal Psychotherapy (IPT)
Interpersonal Psychotherapy
Behavioral: Interpersonal Psychotherapy (IPT)
Interpersonal Psychotherapy

Active Comparator: Individual Psychotherapy
Individual Psychotherapy
Behavioral: Individual Psychotherapy
Individual Psychotherapy

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

Secondary Outcome Measures :
  1. Social Adjustment Scale [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]
  2. Medical Outcomes Survey [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]
  3. Post Traumatic Stress Disorder (PTSD) Symptom Scale [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257400

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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Mental Health (NIMH)
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Principal Investigator: Nancy L. Talbot, PhD University of Rochester
Publications of Results:

Layout table for additonal information Identifier: NCT00257400    
Obsolete Identifiers: NCT00843674
Other Study ID Numbers: K23MH064528 ( U.S. NIH Grant/Contract )
K23MH064528 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: December 2013
Keywords provided by University of Rochester:
major depressive disorder
childhood sexual abuse
Additional relevant MeSH terms:
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Behavioral Symptoms