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临床试验/NCT04007666
NCT04007666已完成不适用

Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users

University of Arkansas4 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2019年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
4
主要终点
Change in PTSD Symptoms by Treatment End and 3 Months Post-Release from Incarceration

研究概览

简要总结

The unmet need for effective addiction treatment within the criminal justice system "represents a significant opportunity to intervene with a high-risk population" according to NIDA's 2016-2020 strategic plan. The plan also encourages the development and evaluation of implementation strategies that address the needs of the criminal justice system. The proposed research will be conducted as part of Dr. Zielinski's Mentored Patient-Oriented Research Career Development Award (K23), which aims to: 1) advance knowledge on implementation of a gold-standard psychotherapy for trauma, Cognitive Processing Therapy (CPT), in the prison setting and 2) examine whether prison-delivered CPT reduces drug use, psychiatric symptoms, and recidivism compared to a control condition (a coping-focused therapy). These foci have been selected because severe trauma exposure, substance use, and justice-involvement overwhelmingly co-occur in prison populations. The three specific aims in this research are: 1) Use formative evaluation to identify factors that may influence implementation and uptake of CPT in prisons, 2) Adapt CPT for incarcerated drug users and develop a facilitation-based implementation guide to support its uptake, and 3) conduct a participant-randomized Hybrid II trial to assess effectiveness and implementation outcomes of CPT with incarcerated drug users. Participants will include people who have been incarcerated (pre- and post-release from incarceration) and prison stakeholders who will be purposively sampled based on their role in implementation of CPT and other programs. Anticipated enrollment across all three Aims is 244 adult men and women.

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
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in PTSD Symptoms by Treatment End and 3 Months Post-Release from Incarceration

时间窗: Pre-treatment assessments will be completed within 4 weeks of treatment start. Post-treatment assessments will be completed within 2 weeks of treatment end. Post-release assessments will be completed approximately 3 months after release from prison.

PTSD symptoms will be assessed using the 20-item PTSD Checklist (PCL-5). Response options are used to indicate the severity of each PTSD symptom and range from 0 (not at all) to 4 (extremely). Total scores range from 0-80. Lower scores indicate lower levels of PTSD symptoms and therefore a better treatment outcome.

Post-Incarceration Drug Use

时间窗: Approximately 3 months after release from incarceration

Drug use will be examined as both binary responses (abstinence vs. any use) and frequency counts (number of days of use). These variables will be derived from information gained via Timeline Follow-Back Interview.

次要结局

  • Recidivism(12 months after release from incarceration)
  • Change in Depression Symptoms by Treatment End and 3 Months Post-Release from Incarceration(Pre-treatment assessments will be completed within 4 weeks of treatment start. Post-treatment assessments will be completed within 2 weeks of treatment end. Post-release assessments will be completed approximately 3 months after release from prison.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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