PTSD Treatment for Incarcerated Men and Women: NIMH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions
研究概览
简要总结
Study examining the feasibility of and 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 10 individuals for CPT in both populations (i.e., 40 participants total; 20F/20M). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.
详细描述
Overall Study Objectives:
The primary objectives of this project include:
- Establish the feasibility of group CPT delivery in male and female incarcerated populations with PTSD;
- Establish the acceptability of group CPT delivery in male and female incarcerated populations with PTSD;
- Establish feasibility of assessment collection for primary outcome measures, secondary outcome measures, and potential mediators and moderators during a clinical trial examining group CPT delivery in incarcerated settings.
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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Intelligence quotient (IQ) greater than or equal to 70
- •18 years old or older
- •Reading level of 4th grade or higher
- •stable medication use (same medication for at least one month)
- •able and willing to participate in group therapy
- •meet PCL-5 criteria for a current PTSD diagnosis within two months of study enrollment
- •no scheduled release date before the end of the treatment group
排除标准
- •currently enrolled in trauma focused treatment that is historical or involves processing of trauma itself
- •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
结局指标
主要结局
Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions
时间窗: up to 6 weeks (by the end of 12th session)
Intervention feasibility measured primarily by participant retention
Change in Self-reported PTSD Symptoms (PCL-5)
时间窗: baseline (one week prior to intervention), post-intervention (up to 13 weeks on study)
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period.
Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)
时间窗: Post (1 week post-intervention, up to 13 weeks on study)
Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
次要结局
- Percentage of Individuals That Meet Study Inclusion Criteria(baseline (one week prior to intervention))
- Percentage of Eligible Individuals Enrolled in the Study(up to start of intervention)
- Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance)(By the end of final treatment session (up to 12 weeks))
- Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist(By the end of final treatment session (up to 12 weeks))
- Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets(By the end of final treatment session (up to 12 weeks))
- Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor(By the end of final treatment session (up to 12 weeks))
- Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II)(post (one week post-intervention, up to 13 weeks on study))
- Reasons for Participant Discontinuation(Up to 3 month follow up (up to 25 weeks))