NCT00220597

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

5.3 years

First QC Date

September 15, 2005

Last Update Submit

December 2, 2013

Conditions

Keywords

group therapysexual revictimizationrisky sexaddiction

Outcome Measures

Primary Outcomes (4)

  • Rates of using of drugs or alcohol

  • Sexual revictimization rates

  • Rates of engaging in risky sex

  • Trauma symptoms

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. 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. 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.
  • \. Meets DSM-IV criteria for current PTSD. 10. Provides informed consent.
  • And at least one of the following:
  • \. 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Psychiatry, Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

AlcoholismCoitusSexual BehaviorSexually Transmitted Diseases, ViralBehavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorSexually Transmitted DiseasesCommunicable DiseasesInfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCompulsive BehaviorImpulsive Behavior

Study Officials

  • David Spiegel, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Catherine C. Classen, Ph.D.

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jack, Lulu & Sam Willson Professor

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

September 1, 1999

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations