Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users (NCT04007666) | Clinical Trial Compass
CompletedNot Applicable
Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users
United States148 participantsStarted 2019-08-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for all participants:
* 18 years of age or older
* Able to understand and speak English
* Able to give informed consent
Inclusion criteria for key stakeholders/informants participating in Aims 1-3 (additional requirements):
* All items listed in "Inclusion criteria for all participants"
* Invited by the PI to participate, due to specific role within project sites (e.g., current Warden, treatment staff member, officer, study therapist)
Inclusion criteria for prisoners completing formative evaluation interviews in Aim 1 and pre-treatment assessments in Aim 3 (additional requirements):
* All items listed in "Inclusion criteria for all participants"
* Incarcerated in either East Central Arkansas Community Correction Center (ECACCC) or Northeast Arkansas Community Correction Center (NEACCC)
* Have a pre-incarceration history of substance use disorder
* Have a history of traumatic event exposure and self-report ongoing trauma-related difficulties
* Be within 9 months of release from incarceration
* Expect to reside in Arkansas throughout the study period
Inclusion criteria for prisoners to enroll in the Hybrid Trial in Aim 3 (additional requirements):
* All items listed in "Inclusion criteria for all participants"
* All items listed in "Inclusion criteria for prisoners completing pre-treatment assessments in Aim 3"
* Evidence clinically significant PTSD symptoms during pre-treatment (baseline) assessment per the Structured Clinical Interview for the DSM
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-Incarceration Drug Use
Timeframe: Approximately 3 months after release from incarceration
2
Change in PTSD Symptoms by Treatment End and 3 Months Post-Release from Incarceration
Timeframe: 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.