Cognitive Processing Therapy for PTSD

(STRIDES2 Trial)

Overseen By Mollee K Smith Steely, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Early release, Scheduling conflicts, Others

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

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks to 3 months

640 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 healthcare provider.

Is Cognitive Processing Therapy (CPT) safe for humans?

Research shows that Cognitive Processing Therapy (CPT) is generally safe for humans, with no CPT-related adverse events reported in trials involving military veterans with PTSD. ^{1 2 3 4 5}

How is Group Cognitive Processing Therapy (CPT) different from other PTSD treatments?

Group Cognitive Processing Therapy (CPT) is unique because it is delivered in a group setting, which can be more efficient and provide peer support compared to individual therapy. It focuses on challenging and changing unhelpful beliefs related to trauma, which helps patients process their traumatic experiences more effectively. ^{1 3 5 6 7}

What is the purpose of this trial?

Addiction and trauma exposure are common among the 5.5 million people (1 in 47 adults) in the U.S. who are in prison or under supervision. About 85% of people in prison have a substance use disorder or are there for a drug-related crime, and many have experienced serious trauma before being incarcerated. Posttraumatic stress symptoms (PTSS) are often a result of trauma and are linked to more severe drug use, higher rates of relapse, and increased crime. PTSS and substance use disorder (SUD) each raise the chances of new arrests for people who are justice-involved, showing that addressing trauma and addiction could help reduce repeat offenses and the costs of incarceration. However, treatments for PTSS are rarely available in prisons, and there is little research on whether providing therapy for PTSS in prison can lower drug use, PTSS, or crime after release. The goal of this clinical trial is to see if trauma-focused group therapy (CPT) provided while in prison, can help people after release from prison. The therapy has been adapted for use in prisons (CPT-CJ) and will be compared to trauma focused therapy delivered via a self-help workbook This study will: * 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 to trauma-focused self-help, * evaluate a strategy called implementation facilitation, which helps support the use of this therapy in prisons, and * measure the cost of the therapies and support strategies to help plan for future expansion. Incarcerated participants (N = 640; 50% female) will be enrolled from \~10 prisons in \~5 states, ensuring variability in population and setting characteristics. They will: * take surveys and answer questions up to 5 times (before starting treatment, right after getting treatment, right before leaving prison, 3 months after leaving prison and 6 months after leaving prison) * complete CPT group therapy or self-help therapy * provide urine samples 3 months and 6 months after leaving prison Prison stakeholders (e.g., prison staff, prison leadership, governmental officials; N = \~15 per site) who will be purposively sampled based on their role in CPT-CJ implementation will also participate in some surveys.

Research Team

Melissa J Zielinski, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for adults in prison who have substance use disorders or are incarcerated for drug-related crimes, and also suffer from post-traumatic stress symptoms. Participants must be willing to undergo group therapy or self-help trauma-focused treatment and provide urine samples after release.

Inclusion Criteria

History of traumatic event exposure

Willing to consent to randomization to treatment condition

Able to give informed consent

Exclusion Criteria

Unable to provide any locator information for post-release assessments

Releasing sooner than would allow completion of CPT-CJ

Unavoidable scheduling conflict or facility restriction that would prevent participation in CPT-CJ

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trauma-focused group therapy (CPT-CJ) or self-help therapy while in prison

6 weeks to 3 months

Up to 12 sessions, 1-2 times per week

Pre-release Assessment

Participants complete assessments and surveys before leaving prison

3 days before release

Follow-up

Participants are monitored for drug use, mental health, and crime post-release

6 months post-release

Surveys and urine samples at 3 and 6 months post-release

Treatment Details

Interventions

• Group Cognitive Processing Therapy (CPT)
• Individual trauma focused self-help via workbook

Trial Overview The study tests if Cognitive Processing Therapy (CPT) adapted for prisons can reduce post-release drug/alcohol use, mental health issues, and crime compared to a self-help workbook approach. It includes surveys and urine tests before, during, and after incarceration.

Participant Groups

Group I: Group Cognitive Processing Therapy (CPT) Active Control 1 Intervention

Participants in CPT group therapy will learn about trauma and how to change upsetting thoughts related to it. Participants will attend up to a total of 12 sessions held 1-2x/week for 90 minutes. No more than 10 participants will be in a group. In this study, CPT provided is a version that was adapted for prisons (CPT-CJ).

Group II: Individual trauma focused self-help via workbook Active Control 1 Intervention

Participants in the trauma-focused self-help therapy will independently read and do practice assignments in a workbook to learn skills to recover from trauma.

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+

Findings from Research

In a study of 268 active-duty servicemembers, individual cognitive processing therapy (CPT) was found to be more effective than group CPT in reducing PTSD severity, with significant improvements noted immediately after treatment.

Both individual and group formats of CPT led to reductions in depression and suicidal ideation, but about 50% of participants still experienced PTSD symptoms after treatment, highlighting the need for improved or new therapeutic options in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Resick, PA., Wachen, JS., Dondanville, KA., et al.[2022]

Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for PTSD, particularly for individuals who have experienced combat, assault, or interpersonal violence, as supported by randomized controlled trials.

The Department of Veterans Affairs has successfully implemented CPT across its healthcare system, with trained clinicians showing good adoption of the therapy and significant improvements in patients' PTSD and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. Chard, KM., Ricksecker, EG., Healy, ET., et al.[2022]

In a study involving 108 active duty military personnel, group cognitive processing therapy (CPT-C) was found to be more effective than group present-centered therapy (PCT) in reducing PTSD symptoms and also significantly improved depression levels, with benefits lasting through follow-up assessments.

Both therapies were well tolerated with few adverse events, highlighting the potential of group therapy as a valuable treatment option for military personnel suffering from PTSD, especially in settings with limited access to individual therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. Resick, PA., Wachen, JS., Mintz, J., et al.[2022]

Cognitive Processing Therapy (CPT) significantly improved symptoms of military-related PTSD in veterans compared to usual treatment, as shown in a randomized controlled trial with 59 participants receiving 12 sessions of therapy.

CPT also led to greater reductions in anxiety, depression, and improvements in social relationships, with no reported adverse events, highlighting its safety and efficacy in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled effectiveness trial of cognitive processing therapy for military-related posttraumatic stress disorder. Forbes, D., Lloyd, D., Nixon, RD., et al.[2018]

Cognitive Processing Therapy (CPT) effectively reduced PTSD symptoms in a study of 18 patients, with 15 participants showing statistically significant improvements in their symptom scores.

The study highlights the successful adaptation of the CPT protocol to address specific barriers faced by trauma survivors, demonstrating its potential for broader implementation in similar treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. Zappert, LN., Westrup, D.[2019]

In a study of 6735 veterans, those receiving individual cognitive processing therapy (CPT) showed a statistically greater reduction in PTSD symptoms at discharge compared to those in group CPT, although the difference was less than the clinically important threshold.

By the 4-month follow-up, there were no significant differences in PTSD symptom severity between the group and individual therapy participants, suggesting that both treatment formats may ultimately lead to similar long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of group v. individual trauma-focused treatment for posttraumatic stress disorder in veterans. Spiller, TR., Duek, O., Buta, E., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled effectiveness trial of cognitive processing therapy for military-related posttraumatic stress disorder. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The comparative effectiveness of cognitive processing therapy for male veterans treated in a VHA posttraumatic stress disorder residential rehabilitation program. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of group v. individual trauma-focused treatment for posttraumatic stress disorder in veterans. [2023]