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临床试验/NCT00220597
NCT00220597已完成不适用

Group Interventions to Prevent HIV in High Risk Women

Stanford University2 个研究点 分布在 1 个国家目标入组 171 人开始时间: 1999年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
171
试验地点
2
主要终点
Sexual revictimization rates

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years of age or older.
  • English-speaking.
  • Has at least two explicit memories of sexual abuse that involved genital contact.
  • At least two sexual abuse events occurred when the survivor was between 4 and15 years of age.
  • The perpetrator was at least 5 years older than the survivor.
  • The survivor knew the perpetrator prior to the sexual abuse.
  • 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.
  • Meets DSM-IV criteria for current PTSD.
  • Provides informed consent.
  • And at least one of the following:
  • Has been sexually revictimized within the previous year.
  • Has engaged in risky sexual behavior within the previous year.
  • Meets DSM-IV criteria for substance abuse

排除标准

  • 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)

结局指标

主要结局

Sexual revictimization rates

Trauma symptoms

Rates of using of drugs or alcohol

Rates of engaging in risky sex

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Spiegel

Jack, Lulu & Sam Willson Professor

Stanford University

研究点 (2)

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