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Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood Sexual Abuse

Primary Purpose

Alcoholism, Child Abuse, Sexual, Sexual Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-focused group therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring group therapy, sexual revictimization, risky sex, addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 1. Female. 2. 18 years of age or older. 3. English-speaking. 4. Has at least two explicit memories of sexual abuse that involved genital contact. 5. At least two sexual abuse events occurred when the survivor was between 4 and15 years of age. 6. The perpetrator was at least 5 years older than the survivor. 7. The survivor knew the perpetrator prior to the sexual abuse. 8. The survivor has discussed or attempted to discuss details of the sexual abuse previously with another person (e.g., family member, friend, or therapist) at least 6 months prior to being interviewed for the study. 9. Meets DSM-IV criteria for current PTSD. 10. Provides informed consent. And at least one of the following: 11. Has been sexually revictimized within the previous year. 12. Has engaged in risky sexual behavior within the previous year. 13. Meets DSM-IV criteria for substance abuse Exclusion Criteria: Criteria for exclusion includes any of the following: Diagnosed as meeting one of the following diagnostic categories: schizophrenia and other psychotic disorders; dementia and delirium and amnestic or other cognitive disorders. Reports ritual abuse. Is currently receiving psychotherapy (including individual or group psychotherapy). Individuals who are alcohol or drug dependent as defined by the DSM-IV. Individuals who are currently suicidal (i.e. within the last month)

Sites / Locations

  • Dept. of Psychiatry, Stanford University

Outcomes

Primary Outcome Measures

Rates of using of drugs or alcohol
Sexual revictimization rates
Rates of engaging in risky sex
Trauma symptoms

Secondary Outcome Measures

Full Information

First Posted
September 15, 2005
Last Updated
December 2, 2013
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00220597
Brief Title
Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood Sexual Abuse
Official Title
Group Interventions to Prevent HIV in High Risk Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effectiveness of trauma-focused group therapy for reducing HIV-risk behavior and revictimization among adult women survivors of childhood sexual abuse (CSA).
Detailed Description
The primary purpose of this study is to evaluate the effectiveness of trauma-focused group therapy for reducing HIV risk behavior and revictimization among adult women survivors of childhood sexual abuse (CSA). Research indicates that childhood sexual abuse is a major risk factor for becoming HIV-infected. Individuals with CSA may be less able to benefit from HIV/AIDS prevention intervention if they are continuing to be traumatized by their earlier CSA experiences that interfere with their learning safer patterns of interpersonal and personal functioning. This study will examine whether or not it is helpful to focus on survivors' memories of CSA in order to reduce HIV risk behavior, revictimization, and distress. It will also examine potential mediators of treatment effectiveness for CSA survivors. This randomized clinical intervention trial will compare trauma-focused group therapy against a present-focused group therapy comparison condition and a case-management only control condition. All three groups will be provided with case management. We will recruit a total of 192 adult women survivors of childhood sexual abuse through newspaper advertisements and through local community organizations (e.g., community health clinics, rape crisis centers). All 192 research participants will meet criteria for posttraumatic stress disorder (PTSD) for CSA as well as have engaged in HIV risk behavior and/or experienced sexual revictimization within the past 3 months. These research participants will be recruited for a randomized clinical intervention trial to evaluate the effectiveness of the trauma-focused and present-focused treatment conditions and to identify mediators of treatment effects. Women for the randomized clinical intervention trial will be recruited in eight cohorts of 24 subjects each for randomization to treatment condition (trauma-focused or present-focused or case management only). Intervention subjects will be assessed on behavioral and other psychosocial measures at baseline and at 3-, 6-, 9-, and 12-month follow-up assessments to evaluate the effectiveness of trauma-focused treatment against the present-focused treatment and the case management only control condition in reducing HIV risk behavior, sexual revictimization, and trauma symptoms, and improving interpersonal functioning. We will examine three mediators of treatment effectiveness, including: 1) trauma reactive and resilient beliefs about self and the world; 2) differentiation and integration of self; and 3) interpersonal relations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Child Abuse, Sexual, Sexual Abuse, Sexual Behavior, Sexually Transmitted Diseases, Viral
Keywords
group therapy, sexual revictimization, risky sex, addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Trauma-focused group therapy
Primary Outcome Measure Information:
Title
Rates of using of drugs or alcohol
Title
Sexual revictimization rates
Title
Rates of engaging in risky sex
Title
Trauma symptoms

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Female. 2. 18 years of age or older. 3. English-speaking. 4. Has at least two explicit memories of sexual abuse that involved genital contact. 5. At least two sexual abuse events occurred when the survivor was between 4 and15 years of age. 6. The perpetrator was at least 5 years older than the survivor. 7. The survivor knew the perpetrator prior to the sexual abuse. 8. The survivor has discussed or attempted to discuss details of the sexual abuse previously with another person (e.g., family member, friend, or therapist) at least 6 months prior to being interviewed for the study. 9. Meets DSM-IV criteria for current PTSD. 10. Provides informed consent. And at least one of the following: 11. Has been sexually revictimized within the previous year. 12. Has engaged in risky sexual behavior within the previous year. 13. Meets DSM-IV criteria for substance abuse Exclusion Criteria: Criteria for exclusion includes any of the following: Diagnosed as meeting one of the following diagnostic categories: schizophrenia and other psychotic disorders; dementia and delirium and amnestic or other cognitive disorders. Reports ritual abuse. Is currently receiving psychotherapy (including individual or group psychotherapy). Individuals who are alcohol or drug dependent as defined by the DSM-IV. Individuals who are currently suicidal (i.e. within the last month)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spiegel, M.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine C. Classen, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Psychiatry, Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood Sexual Abuse

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