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临床试验/NCT00602069
NCT00602069已完成1 期

Treatment of PTSD in Recently Battered Women Living in Shelters

The University of Akron2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
2
主要终点
PTSD symptom severity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

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

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

排除标准

  • 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

结局指标

主要结局

PTSD symptom severity

时间窗: Measured at Month 8

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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