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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-16

Study Completion Date

2025-05-08

Brief Summary

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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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Detailed Description

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Conditions

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Substance Use Disorders Drug Abuse Alcohol Abuse Posttraumatic Stress Disorder PTSD Recidivism Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Processing Therapy (CPT)

CPT is a gold-standard 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. It can be delivered in group and individual formats, but will be delivered in a group format in this project due to feasibility in the setting. Structure will be based on feedback obtained during completion of Aim 2 while remaining within the range evaluated in prior research (i.e., 8-12 sessions, 1-2x per week, each lasting 1.5-2 hours).

Group Type EXPERIMENTAL

Cognitive Processing Therapy

Intervention Type 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.

Coping Skills Group

The Coping Skills Group will match for attention and dose, without adding any cost to the system. Exact content will be determined during completion of Aim 2; however, project sites already provide coping-focused programming and coping-skill approaches to trauma treatment are a common alternative to evidence-based therapies for PTSD, such as CPT, that deal more directly with the index trauma. To provide an enhanced standard of care, the investigator will review treatment materials (workbooks, handouts) already used in prison settings and arrange a curriculum of skills similar to those in coping-focused trauma-informed interventions (e.g., psychoeducation, assertiveness).

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type BEHAVIORAL

Coping-focused treatment.

Interventions

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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.

Intervention Type BEHAVIORAL

Control Group

Coping-focused treatment.

Intervention Type BEHAVIORAL

Other Intervention Names

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CPT

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Able to understand and speak English
* Able to give informed consent

* Invited by the PI to participate, due to specific role within project sites (e.g., current Warden, treatment staff member, officer, study therapist)

* 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

* 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)