Zielinski Melissa J, Smith Mollee K Steely, Kaysen Debra, Selig James P, Zaller Nickolas D, Curran Geoffrey, Kirchner JoAnn E
University of Arkansas for Medical Sciences, Little Rock, AR, USA.
University of Arkansas, Fayetteville, USA.
Health Justice. 2022 Oct 1;10(1):30. doi: 10.1186/s40352-022-00192-8.
Trauma exposure and drug addiction go hand-in-hand for the 2.17 million people who are incarcerated in US prisons; prevalence of both exceed 80% among this population. This manuscript describes the rationale and methods for a participant-randomized effectiveness-implementation hybrid type II pilot trial designed to: 1) examine the effectiveness of Cognitive Processing Therapy group (CPT), an evidence-based psychotherapy for posttraumatic stress disorder (PTSD), for reducing post-release drug use and PTSD symptoms when adapted for and delivered in prisons; and 2) provide data on implementation outcomes associated with the use of implementation facilitation as a strategy for supporting uptake of CPT in prisons.
Participants in the effectiveness portion of the trial (N = 120) will be incarcerated men and women who are randomly assigned to one of two group therapies: CPT or a control condition (PTSD coping skills group; PCS). Participants will complete assessment measures three times: pre-treatment, post-treatment, and 3 months following release from incarceration. CPT groups will be led by prison counselors who are receiving implementation facilitation to support their efforts. PCS groups will be led by trained clinicians on the research team. Implementation outcomes will include acceptability, appropriateness, adoption, feasibility, fidelity, and sustainability. After enrollment ends, the research team will monitor CPT sustainment and recidivism outcomes of study participants for one year.
This study will lay the groundwork for a larger study of interventions for co-occurring PTSD and SUD in prisons and, critically, inform the development of strategies (such as implementation facilitation) for supporting their uptake in routine practice.
NCT04007666 , clinicaltrials.gov, 24 June 2019, 02 September 2021.
在美国监狱中服刑的217万人同时面临创伤暴露和药物成瘾问题；这两种情况在该人群中的患病率均超过80%。本手稿描述了一项参与者随机分组的有效性-实施混合型II期试点试验的基本原理和方法，该试验旨在：1）检验认知加工疗法组（CPT）（一种针对创伤后应激障碍（PTSD）的循证心理治疗方法）在监狱中进行调整和实施时，对于减少出狱后药物使用和PTSD症状的有效性；2）提供与使用实施促进作为支持CPT在监狱中应用的策略相关的实施结果数据。
试验有效性部分的参与者（N = 120）将是被监禁的男性和女性，他们被随机分配到两种团体治疗之一：CPT或对照条件（PTSD应对技能组；PCS）。参与者将在三个时间点完成评估措施：治疗前、治疗后以及出狱后3个月。CPT组将由接受实施促进以支持其工作的监狱辅导员带领。PCS组将由研究团队中经过培训的临床医生带领。实施结果将包括可接受性、适宜性、采用情况、可行性、保真度和可持续性。在招募结束后，研究团队将对研究参与者的CPT持续情况和累犯结果进行一年的监测。
本研究将为在监狱中同时发生的PTSD和物质使用障碍（SUD）的干预措施的更大规模研究奠定基础，并且至关重要的是，为支持这些干预措施在常规实践中应用的策略（如实施促进）的制定提供信息。
NCT04007666，clinicaltrials.gov，2019年6月24日，2021年9月2日。
