PTSD Treatment for Incarcerated Men and Women: Arnold Ventures (AV)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Number of Conduct Reports
研究概览
简要总结
This research will help identify if a PTSD treatment group, called Cognitive Processing Therapy (CPT), that is used in community settings is helpful in reducing PTSD symptoms among people who are incarcerated. The goal of CPT is to create a space for people to modify unhelpful beliefs related to trauma. A total of 692 participants will be enrolled from 6 locations and can expects to be on study for up to 24 weeks.
详细描述
The primary objective of this project is to determine the effectiveness of group CPT in reducing conduct reports (violations of prison rules such assaults and substance use), reducing PTSD symptom severity, and address the long-term outcome of recidivism in male and female incarcerated populations.
Up to 692 incarcerated individuals will participate in group assignment. To account for potential participant attribution between consent, group assignment, and the waitlist group receiving treatment, enrollment could be up to 900 participants. AV branch of the study involves a waitlist control group; this group will receive the CPT treatment after the treatment group completes the treatment. Participation in the waitlist control group will not affect participation in any other treatments that are available at the facilities.
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.
Eligible participants will complete the PCL-5 to ascertain current PTSD symptomology and probable diagnosis. This assessment will take approximately 90 minutes.
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)
盲法说明
The research members performing the assessments will be blind to the group assignment. One study staff will schedule participants according to the randomization, thus minimizing the possibility of systematically biasing the outcome and mediator assessments.
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
- •Participants will be enrolled from the Department of Corrections trauma treatment waitlist who have been screened for:
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
Cognitive Processing Therapy (CPT) group
Participant groups of 6-10 people to receive CPT to treat PTSD over 6 weeks or 12 weeks, depending on session frequency.
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
Number of Conduct Reports
时间窗: Up to 26 weeks on study
Effectiveness of group CPT in reducing conduct reports measured by number of violations of prison rules such assaults and substance use.
次要结局
- Change in PTSD Checklist for DSM-5 (PCL-5) severity score(baseline (pre-intervention), up to 12 weeks (post-intervention), and up to 24 weeks (three months follow up))