NCT04007666

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

Completed NA Last updated 29 July 2025

What this trial tests

NA trial testing Cognitive Processing Therapy in Substance Use Disorders in 148 participants. Completed in 8 May 2025.

Timeline

16 August 2019

Primary endpoint
8 May 2025

8 May 2025

Quick facts

Lead sponsor	University of Arkansas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	148
Start date	16 August 2019
Primary completion	8 May 2025
Estimated completion	8 May 2025
Sites	2 locations across United States

Drugs / interventions tested

• Cognitive Processing Therapy
• Control Group — full drug profile →

Conditions studied

• Substance Use Disorders — all drugs for Substance Use Disorders →
• Drug Abuse — all drugs for Drug Abuse →
• Alcohol Abuse — all drugs for Alcohol Abuse →
• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

University of Arkansas

Who can join

18 and older, any sex, with Substance Use Disorders or Drug Abuse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A participant-randomized pilot hybrid II trial of group cognitive processing therapy for incarcerated persons with posttraumatic stress and substance use disorder symptoms: study protocol and rationale.
   Zielinski MJ, Smith MKS, Kaysen D, Selig JP, et al · · 2022 · cited 3× · PMID 36181587 · DOI 10.1186/s40352-022-00192-8