Clinical trial NCT00220597: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Child Abuse, Sexual
Sexual Abuse
Sexual Behavior
Sexually Transmitted Diseases, Viral
Keywords: group therapy
sexual revictimization
risky sex
addiction
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-22
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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:

  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)

Primary outcomes:
measure: Rates of using of drugs or alcohol
measure: Sexual revictimization rates
measure: Rates of engaging in risky sex
measure: Trauma symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Dept. of Psychiatry, Stanford University
state: California
Study officials:
affiliation: Stanford University
name: David Spiegel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Catherine C. Classen, Ph.D.
role: STUDY_DIRECTOR
References: