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Clinical Trials/NCT00602069
NCT00602069
Completed
Phase 1

Treatment of PTSD in Recently Battered Women Living in Shelters

The University of Akron1 site in 1 country60 target enrollmentMay 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorder
Sponsor
The University of Akron
Enrollment
60
Locations
1
Primary Endpoint
PTSD symptom severity
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This study will evaluate the effectiveness of a brief cognitive behavioral treatment, Helping to Overcome PTSD through Empowerment, in treating abused women with post-traumatic stress disorder who are living in shelters.

Detailed Description

Intimate partner violence is a serious social problem with potentially severe mental health and functional consequences consistent with post-traumatic stress disorder (PTSD). Shelters provide an important resource for abused women in that they offer emergency shelter, support, and access to community resources that can aid in establishing long-term safety for women and their children. However, recent research suggests that symptoms of PTSD can compromise abused women's ability to access and effectively use these resources, emphasizing the importance of initiating treatment for PTSD. Despite the fact that on an annual basis 300,000 battered women and children access shelter services, virtually no research has investigated treatment of PTSD in sheltered abused women. A woman's entry into a shelter seems to be a prime time to begin any necessary psychological treatment. Helping to Overcome PTSD through Empowerment (HOPE), a brief cognitive behavioral treatment that emphasizes stabilization and empowerment of women, may help in treating abused women with PTSD. This study will evaluate the effectiveness of HOPE in treating abused women with PTSD who are in shelters. Participation in this single-blind study will begin during a woman's shelter stay and will end 8 months after she completes the shelter treatment period. All potential participants will first undergo an initial interview, which will include questions about their abusive relationships, emotional difficulties, stressful events, and other previous treatments. Participants invited to continue with the study will be randomly assigned to the HOPE program or to shelter treatment as usual. Participants assigned to the HOPE program will participate in a maximum of 16 counseling sessions, with up to 10 of these sessions taking place while they are at the shelter. During these sessions, participants will learn skills to help manage emotional difficulties and ways to deal with their abusive relationships. Participants will attend two 60- to 90-minute sessions each week until they complete of the 10 shelter-based counseling sessions or depart from the shelter. Counseling sessions will continue at St. Thomas Hospital or other agreed-upon location twice per week during the first 8 weeks after departure from the shelter. All participants will repeat the initial interview and/or questionnaire at various times during and after the shelter stay, for a total of eight assessments. The final interview assessment will occur 6 months after participants complete the counseling sessions.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
May 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Meets criteria for PTSD or subthreshold PTSD
  • Resident of a battered women's shelter
  • Abused in the month prior to study entry

Exclusion Criteria

  • Significant suicidal ideation or risk
  • Current psychotic symptoms
  • Current alcohol or drug dependence
  • Lifetime history of bipolar disorder
  • Concurrent psychosocial treatment
  • Any change in medication in the month prior to study entry

Outcomes

Primary Outcomes

PTSD symptom severity

Time Frame: Measured at Month 8

Secondary Outcomes

  • Effective use of resources(Measured at Month 8)
  • Resource loss(Measured at Month 8)
  • Depression(Measured at Month 8)
  • Social functioning(Measured at Month 8)
  • Revictimization(Measured at Month 8)

Study Sites (1)

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