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Completed

NCT Number: NCT04007666

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

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.

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Key information

Conditions

Substance Use Disorders Alcohol Abuse Alcohol-Related Disorders Alcoholism Behavior Behavioral Symptoms Chemically-Induced Disorders Criminal Behavior Depression Drug Abuse Mental Disorders PTSD Posttraumatic Stress Disorder Recidivism Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Arkansas Community Correction Center (NEACCC), Osceola, Arkansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive processing therapy

Behavioral

Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD that combines education about trauma with strategies to challenge the trauma-related cognitions that are theorized to maintain PTSD symptoms.

Other names: CPT

Control Group

Behavioral

Coping-focused treatment.

Primary outcomes

  1. Post-Incarceration Drug Use

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Change in Depression Symptoms by Treatment End and 3 Months Post-Release from Incarceration

    Time frame: 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.

    Depression symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). Response options are using to indicate the severity of each symptom of depression and range from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27. Lower scores indicate lower levels of depression symptoms and therefore a better treatment outcome.

  2. Recidivism

    Time frame: 12 months after release from incarceration

    Recidivism will be extracted from administrative incarceration records and examined as both a binary variable (presence or absence of any drug-related recidivism) and frequency counts (number of new drug charges).

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2019
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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