Women Overcoming and Managing Adversity Now (WOMAN) Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- PTSD
研究概览
简要总结
The goal of the study is to evaluate the efficacy of a two therapeutic models designed to enhance women's skills for managing reactive emotions in their current lives as well as to educate them about how using these skills can enhance their personal effectiveness and help them to gain control of post-traumatic stress reactions. The interventions adaptations of a manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared to a supportive group therapy (SGT) that has been found to have modest benefits with women survivors of childhood abuse (Wallis, 2002).
详细描述
In a randomized treatment design, we will compare offenders receiving skills-based intervention (TARGET) and those receiving a similar amount of supportive intervention (SGT). We will assess the efficacy of treatment by determining if those receiving the TARGET skills training show an improvement in functionality, as compared to those receiving only supportive intervention. We will measure this by analyzing PTSD symptoms, psychological distress, psychosocial functioning, and social/legal adjustment and services using structured interviews, self-report questionnaires and qualitative questions. Questionnaires are listed below in the outcome measure's section. We will collect follow-up data on program participants who successfully finish the program at York. For those offenders who discharge into the community directly from York, we will collect follow-up data on program participants through CDOC Parole or Probation records. Statistically we anticipate a medium effect size difference between the treatment conditions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Incarcerated, release not expected within 6 months
- •Probable PTSD on PC-PTSD screen and PTSD by CAPS interview
排除标准
- •Clinically significant psychopathy (PCL-SV severe range)
- •Unable to comprehend study materials (Mini-Mental Status Exam Orientation, Attention, and Recall sections total score <15).
结局指标
主要结局
PTSD
时间窗: 3-4 Month Post-therapy Follow-up
PTSD symptom severity, Clinician Administered PTSD Scale
次要结局
- Emotion Regulation(3-4 Month Post-therapy Follow-up)
- Trauma-related symptoms(Post-therapy (within 2 weeks))
- Mental health symptoms, well-being, and self-harm(3-4 Month Post-therapy Follow-up)
- Trauma-related Symptoms(3-4 Month Post-therapy Follow-up)