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
  Purpose

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 Intervention
Alcoholism
Child Abuse, Sexual
Sexual Abuse
Sexual Behavior
Sexually Transmitted Diseases, Viral
Behavioral: Trauma-focused group therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Group Interventions to Prevent HIV in High Risk Women

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Rates of using of drugs or alcohol
  • Sexual revictimization rates
  • Rates of engaging in risky sex
  • Trauma symptoms

Enrollment: 171
Study Start Date: September 1999
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:

    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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220597

Locations
United States, California
Dept. of Psychiatry, Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: David Spiegel, M.D. Stanford University
Study Director: Catherine C. Classen, Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: David Spiegel, Jack, Lulu & Sam Willson Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00220597     History of Changes
Other Study ID Numbers: R01 MH60556, R01MH060556, DAHBR AZ-Q
Study First Received: September 15, 2005
Last Updated: December 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
group therapy
sexual revictimization
risky sex
addiction

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

ClinicalTrials.gov processed this record on October 20, 2014