Women Overcoming and Managing Adversity Now (WOMAN) Study (WOMAN)
2011年3月28日 更新者：UConn Health
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
108
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Connecticut
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Niantic、Connecticut、美国、06357
- York Correctional Institution
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Incarcerated, release not expected within 6 months
- Probable PTSD on PC-PTSD screen and PTSD by CAPS interview
Exclusion Criteria
- Clinically significant psychopathy (PCL-SV severe range)
- Unable to comprehend study materials (Mini-Mental Status Exam Orientation, Attention, and Recall sections total score <15).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TARGET
12-session affect regulation therapy for PTSD
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12-session group therapy twice weekly 6 weeks
|
|
有源比较器：SGT
12 session supportive group therapy
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12 sessions supportive group therapy twice weekly 6 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PTSD
大体时间：Post-therapy (within 2 weeks)
|
PTSD symptom severity, Clinician Administered PTSD Scale
|
Post-therapy (within 2 weeks)
|
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PTSD
大体时间：3-4 Month Post-therapy Follow-up
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PTSD symptom severity, Clinician Administered PTSD Scale
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3-4 Month Post-therapy Follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Emotion Regulation
大体时间：Post-therapy (within 2 weeks)
|
Negative Mood Regulation Scale
|
Post-therapy (within 2 weeks)
|
|
Trauma-related symptoms
大体时间：Post-therapy (within 2 weeks)
|
Trauma Symptom Inventory (TSI; Briere, 1995).
The TSI is a reliable and validated 100-item measure that generates composite scores for trauma (PTSD symptoms), self (self-regulation problems), and dysphoria (depression, anxiety, anger symptoms).
|
Post-therapy (within 2 weeks)
|
|
Mental health symptoms, well-being, and self-harm
大体时间：Post-therapy (within 2 weeks)
|
CORE-OM is a 34-item self-report measure reliably and validly assessing current psychiatric symptom severity, risk of harm to self or others, social functioning, and subjective well being
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Post-therapy (within 2 weeks)
|
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Emotion Regulation
大体时间：3-4 Month Post-therapy Follow-up
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Negative Mood Regulation Scale
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3-4 Month Post-therapy Follow-up
|
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Trauma-related Symptoms
大体时间：3-4 Month Post-therapy Follow-up
|
Trauma Symptom Inventory
|
3-4 Month Post-therapy Follow-up
|
|
Mental health symptoms, well-being, and self-harm
大体时间：3-4 Month Post-therapy Follow-up
|
CORE-OM 34-item questionnaire
|
3-4 Month Post-therapy Follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Julian D Ford, Ph.D.、UConn Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年1月1日
初级完成 (实际的)
2010年11月1日
研究完成 (实际的)
2010年11月1日
研究注册日期
首次提交
2010年9月23日
首先提交符合 QC 标准的
2011年3月28日
首次发布 (估计)
2011年3月29日
研究记录更新
最后更新发布 (估计)
2011年3月29日
上次提交的符合 QC 标准的更新
2011年3月28日
最后验证
2011年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.