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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04007666
• Other study ID #: 229172
• Secondary ID: K23DA048162
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 16, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: April 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Depression
• Drug Abuse
• Posttraumatic Stress Disorder
• PTSD
• Recidivism
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Cognitive Processing Therapy
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.
• Control Group
Coping-focused treatment drawn from material already offered in selected facilities.

Locations

Country	Name	City	State
United States	Northeast Arkansas Community Correction Center (NEACCC)	Osceola	Arkansas
United States	East Central Arkansas Community Correction Center (ECACCC)	West Memphis	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Incarceration Drug Use	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.	Approximately 3 months after release from incarceration
Primary	Change in PTSD Symptoms by Treatment End and 3 Months Post-Release from Incarceration	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.	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.
Secondary	Change in Depression Symptoms by Treatment End and 3 Months Post-Release from Incarceration	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.	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.
Secondary	Recidivism	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).	12 months after release from incarceration