AzTrials
AzTrials

AlcoholismNCT00220597

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

A study testing Trauma-focused group therapy in people with Alcoholism and Child Abuse, Sexual, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Alcoholism, Child Abuse, Sexual, Sexual Abuse
What is being tested?
Trauma-focused group therapy
How many people
171 participants
Where
1 siteUnited States
Study dates
Sep 1999to Dec 2004
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dept. of Psychiatry, Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Trauma-focused group therapy
Keywords
group therapy, sexual revictimization, risky sex, addiction
Medical subject headings
Alcoholism, Coitus, Sexual Behavior, Sexually Transmitted Diseases, Viral, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-focused group therapyBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates of using of drugs or alcohol

  2. Sexual revictimization rates

  3. Rates of engaging in risky sex

  4. Trauma symptoms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startSep 1999
  3. Primary completionDec 2004
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00220597
Sponsor's protocol ID
R01MH060556
Other IDs
R01MH060556, DAHBR AZ-Q
Status last verified
Dec 2013
First submitted
15 Sep 2005
Last updated
3 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Trauma-focused group therapy in people with Alcoholism and Child Abuse, Sexual, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of using of drugs or alcohol. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013; AzTrials last refreshed its copy on 7 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in