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