Cognitive Processing Therapy for Substance Use Disorders

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Cognitive Processing Therapy (CPT), a type of talk therapy for trauma, can reduce drug use, mental health issues, and repeat offenses among people in prison. Participants will receive either CPT or a coping skills group therapy for comparison. The trial seeks individuals who have been in prison, have a history of substance use disorder, and are dealing with ongoing trauma-related issues. It focuses on those within nine months of release who will remain in Arkansas during the study. As an unphased trial, this study offers a unique opportunity to contribute to understanding how therapy can support individuals transitioning back to the community.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Cognitive Processing Therapy is safe for use in prison settings?

Research shows that Cognitive Processing Therapy (CPT) is generally safe and well-tolerated across diverse groups. Studies have found that CPT effectively treats PTSD (post-traumatic stress disorder) without requiring additional preparation. This therapy helps change negative thoughts related to trauma, enabling many to manage their symptoms better.

In clinical trials, participants with substance use disorders (SUD) completed CPT successfully without major side effects. Researchers have tested it in various settings and with different groups, including those with SUD, without increased risks or dropouts. Overall, CPT has proven to be a dependable option for many, making it a promising choice for those interested in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Processing Therapy (CPT) for substance use disorders because it brings a powerful approach previously used for PTSD into this new domain. Unlike typical treatments for substance use that primarily focus on managing cravings and building coping skills, CPT tackles the underlying trauma-related thoughts that might contribute to substance use. Delivered in a group format, this therapy not only provides peer support but also offers a structured environment to challenge and reframe harmful beliefs, potentially leading to more sustainable recovery.

What evidence suggests that Cognitive Processing Therapy could be an effective treatment for substance use disorders?

Research has shown that Cognitive Processing Therapy (CPT), which participants in this trial may receive, effectively treats PTSD (post-traumatic stress disorder) symptoms across various groups and settings. Studies have found that CPT reduces trauma-related symptoms by changing unhelpful beliefs about the traumatic event. In some cases, it also reduces substance use and related problems. For individuals with both PTSD and substance use disorders, CPT has improved mental health. Overall, CPT is considered a leading treatment for trauma and may also aid with substance use issues when trauma is involved. ^{1 2 3 6 7}

Who Is on the Research Team?

Melissa Zielinski, Phd

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5803416/

Development of a Novel, Integrated Cognitive-Behavioral ... The present pilot randomized clinical trial was designed to evaluate the feasibility and preliminary efficacy of a novel, integrated cognitive-behavioral ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy The research literature indicates that CPT is effective without preparatory treatment across a range of outcomes, settings, and populations.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06923423

NCT06923423 | Effectiveness, Implementation, and Cost of ... test whether a trauma-focused group therapy (CPT-CJ) can reduce post-incarceration drug and alcohol use, mental health issues, and drug-related crime, compared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3855895/

Cognitive Processing Therapy for Veterans with Comorbid ... The present study examines the extent to which CPT is tolerated by and effective in treating PTSD symptoms for veterans with PTSD and AUD.

5. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1634266.pdf

State of the Science of Cognitive Processing Therapy Data from in situ programs also show veterans who receive CPT improve on suicidal ideation and thoughts of burdensomeness and belongingness, which are ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788220

Comparison of Prolonged Exposure vs Cognitive ... CPT participants were more likely to complete in 12 sessions (115 participants [25.3%]), whereas PE participants were more likely to be early ...

7. mdpi.com mdpi.com/2076-328X/15/8/1000

Integrated Cognitive Processing Therapy and Relapse ... ... cognitive behavioral therapy (CBT) for substance use disorders. Data from numerous randomized clinical trials demonstrate the safety, feasibility, and ...