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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Spiegel, Stanford University
ClinicalTrials.gov Identifier:
NCT00220597
First received: September 15, 2005
Last updated: December 2, 2013
Last verified: December 2013

September 15, 2005
December 2, 2013
September 1999
December 2004   (final data collection date for primary outcome measure)
  • Rates of using of drugs or alcohol
  • Sexual revictimization rates
  • Rates of engaging in risky sex
  • Trauma symptoms
Same as current
Complete list of historical versions of study NCT00220597 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood Sexual Abuse
Group Interventions to Prevent HIV in High Risk Women

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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alcoholism
  • Child Abuse, Sexual
  • Sexual Abuse
  • Sexual Behavior
  • Sexually Transmitted Diseases, Viral
Behavioral: Trauma-focused group therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
December 2004
December 2004   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00220597
R01 MH60556, R01MH060556, DAHBR AZ-Q
No
David Spiegel, Stanford University
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
Stanford University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP