Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood 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: NCT00220597
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 3, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Spiegel, Stanford University

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).

Condition or disease Intervention/treatment Phase
Alcoholism Child Abuse, Sexual Sexual Abuse Sexual Behavior Sexually Transmitted Diseases, Viral Behavioral: Trauma-focused group therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Interventions to Prevent HIV in High Risk Women
Study Start Date : September 1999
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Rates of using of drugs or alcohol
  2. Sexual revictimization rates
  3. Rates of engaging in risky sex
  4. Trauma symptoms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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:

    1. Diagnosed as meeting one of the following diagnostic categories: schizophrenia and other psychotic disorders; dementia and delirium and amnestic or other cognitive disorders.
    2. Reports ritual abuse.
    3. Is currently receiving psychotherapy (including individual or group psychotherapy).
    4. Individuals who are alcohol or drug dependent as defined by the DSM-IV.
    5. Individuals who are currently suicidal (i.e. within the last month)

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): NCT00220597

United States, California
Dept. of Psychiatry, Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Principal Investigator: David Spiegel, M.D. Stanford University
Study Director: Catherine C. Classen, Ph.D. Stanford University

Responsible Party: David Spiegel, Jack, Lulu & Sam Willson Professor, Stanford University Identifier: NCT00220597     History of Changes
Other Study ID Numbers: R01MH060556 ( U.S. NIH Grant/Contract )
R01MH060556 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013

Keywords provided by David Spiegel, Stanford University:
group therapy
sexual revictimization
risky sex

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female