PTSD Treatment for Incarcerated Men and Women: WPP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Change in PTSD Checklist for DSM-5 (PCL-5) severity score
研究概览
简要总结
Study examining the psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of individuals for both CPT and waitlist control in both populations (180 participants total).
详细描述
Overall Study Objectives:
The primary objectives of this project include:
- Determine the effectiveness of CPT in reducing PTSD symptom severity;
- Identify putative psychological mechanisms of response to CPT through pre-, mid-, and post-intervention measures of PTSD symptom severity as well as measures of hopelessness, self-blame, and negative self-related thoughts.
Prior to beginning any study procedures, informed consent will be obtained orally and in writing. During the informed consent process, eligible participants will be provided with detailed information about the study, including their right to refuse or discontinue participation at any time and the fact that their decision to participate or decline will have no bearing on their standing within the criminal justice system.
Potential participants will be contacted by calling them over the phone system within the prison. When they arrive to the private testing room, they are asked if they would like to learn about the study and potentially participate. If so, participants undergo consent.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •meet PCL-5 criteria for current PTSD diagnosis within 2 months of enrollment
- •no scheduled release date before the end of the treatment group
- •able to understand the consent form as measured by the consent quiz
- •have not participated in the previous CPT groups with UW project
- •No active symptoms of psychosis that would interfere with the individual's ability to participate in the group
- •No active suicidal ideation with intent or plan
- •Able and willing to participate in group therapy
排除标准
- 未提供
研究组 & 干预措施
Cognitive Processing Therapy (CPT) group
Participant groups to receive CPT to treat PTSD
干预措施: Cognitive Processing Therapy (Behavioral)
Waitlist Control
Participant groups will provide data as a control group first, and will then receive CPT to treat PTSD
结局指标
主要结局
Change in PTSD Checklist for DSM-5 (PCL-5) severity score
时间窗: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy
次要结局
- Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements(Up to 7 weeks (by the end of the 12th session))
- Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist(Up to 7 weeks (by the end of the 12th session))
- Change in score on the Beck Depression Inventory 2 (BDI-II)(baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment))
- Change in score on the Beck Anxiety Inventory (BAI)(baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment))
- Percentage of participants endorsing 2 or higher on Q9 of BDI-II(baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment))
- Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements(Up to 7 weeks (by the end of the 12th session))
- Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist(Up to 7 weeks (by the end of the 12th session))