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临床试验/NCT00183716
NCT00183716已完成3 期

An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model

Dartmouth-Hitchcock Medical Center4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
300
试验地点
4
主要终点
PTSD symptom severity

研究概览

简要总结

This study will determine the effectiveness of the Trauma Recovery and Empowerment Model in reducing the severity of post-traumatic stress disorder symptoms in women with mental disorders and who have experienced sexual or physical abuse.

详细描述

Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened. Rates of PTSD are extremely high among people with severe mental disorders and such individuals find themselves at increased risk for depression, substance abuse, and poor overall health. In turn, these issues lead to high rates of utilization of mental health services. Unfortunately, there is currently a lack of effective trauma treatments that can be implemented in routine mental health settings. Trauma Recovery and Empowerment Model (TREM) is a group-based intervention that addresses PTSD and other closely related consequences of sexual and physical abuse among women with severe mental disorders. This study will determine the effectiveness of TREM in reducing the severity of PTSD symptoms in women with mental disorders who have experienced sexual or physical abuse.

Participants in this open label study will be randomly assigned to receive either usual care alone or usual care combined with TREM for 18 months. Usual care will include medication, case management, and therapy administered by a primary clinician. Participants assigned to usual care will report to the study site at least once a week, or as often as necessary. Participants assigned to usual care plus TREM will also be assigned to a primary clinician and will receive usual care as often as necessary. In addition, TREM participants will take part in 29 group sessions that will focus on increasing self-esteem and trauma-coping skills and reducing self-blame. PTSD symptom severity, trauma beliefs, depressive symptoms, substance use, and mental health service utilization will be measured at Months 6, 12, and 18 for all participants.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • History of physical and/or sexual abuse
  • Diagnosis of a severe mental disorder
  • Diagnosis of PTSD with a symptom severity score of 21 or higher

排除标准

  • Severe developmental disabilities or organic brain damage

结局指标

主要结局

PTSD symptom severity

时间窗: Measured at baseline and Months 6, 12, and 18

次要结局

  • Distorted beliefs(Measured at baseline and Months 6, 12, and 18)
  • Depressive symptoms(Measured at baseline and Months 6, 12, and 18)
  • Substance use(Measured at baseline and Months 6, 12, and 18)
  • Mental health service utilization(Measured at Months 6, 12, and 18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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