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

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

Detailed Description
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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.

Official Title
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Interpersonal Psychotherapy for Depressed Women With Sexual Abuse Histories

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Interpersonal Psychotherapy (IPT)
* Behavioral: Individual Psychotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interpersonal Psychotherapy (IPT)<br>Interpersonal Psychotherapy | Behavioral: Interpersonal Psychotherapy (IPT)<br>* Interpersonal Psychotherapy<br>|
| Active Comparator: Individual Psychotherapy<br>Individual Psychotherapy | Behavioral: Individual Psychotherapy<br>* Individual Psychotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depressive disorder, psychotherapy, childhood sexual abuse, trauma