Cognitive Processing Therapy for Substance Use Disorders

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Unwilling to consent, Unable to provide locator

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

148 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Melissa Zielinski, Phd

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for adults over 18 who are incarcerated in Arkansas, within 9 months of release, and have a history of substance use disorder and trauma. They must understand English, consent to participate, and be able to provide contact information post-release.

Inclusion Criteria

You have symptoms of PTSD that are confirmed by a special interview with a doctor.

I was released from jail or prison within the last 9 months.

The PI has invited specific people to participate in the study due to their roles at the treatment sites

Exclusion Criteria

Unwilling to consent to randomization

Unable to provide locator information for post-release assessments

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Processing Therapy (CPT) or Coping Skills Group therapy in a group format, with sessions occurring 1-2 times per week for 8-12 sessions.

8-12 weeks

Follow-up

Participants are monitored for changes in PTSD and depression symptoms, as well as drug use, post-release from incarceration.

3 months

Long-term Follow-up

Recidivism and other long-term outcomes are assessed 12 months after release from incarceration.

12 months

Treatment Details

Interventions

• Cognitive Processing Therapy
• Control Group

Trial Overview The study tests Cognitive Processing Therapy (CPT) for treating trauma in incarcerated drug users compared to a control therapy focused on coping. It aims to see if CPT can reduce drug use, psychiatric symptoms, and recidivism.

Participant Groups

Group I: Cognitive Processing Therapy (CPT) Experimental Treatment 1 Intervention

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 II: Coping Skills Group Active Control 1 Intervention

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).

Cognitive Processing Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+