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

Last updated: July 28, 2025
Sponsor: University of Arkansas
Overall Status: Completed

Phase

N/A

Condition

Alcohol Dependence

Stimulant Use Disorder

Alcohol Use Disorder

Treatment

Cognitive Processing Therapy

Control Group

Clinical Study ID

NCT04007666
229172
K23DA048162
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

  • Have a pre-incarceration history of substance use disorder (confirmed by clinical interview)

Exclusion criteria for prisoners to enroll in the Hybrid Trial in Aim 3 (additional requirements):

  • Unwilling to consent to randomization

  • Unable to provide locator information for post-release assessments

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: Cognitive Processing Therapy
Phase:
Study Start date:
August 16, 2019
Estimated Completion Date:
May 08, 2025

Connect with a study center

  • Northeast Arkansas Community Correction Center (NEACCC)

    Osceola, Arkansas 72370
    United States

    Site Not Available

  • East Central Arkansas Community Correction Center (ECACCC)

    West Memphis, Arkansas 72301
    United States

    Site Not Available

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