Cognitive Processing Therapy for PTSD

(STRIDES2 Trial)

Recruiting at 3 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if group therapy focusing on trauma can reduce drug and alcohol use, mental health issues, and crime after release from prison. Participants will either join up to 12 group sessions for Cognitive Processing Therapy (CPT) or use a self-help workbook to learn about handling trauma. The research will also examine how well these therapies can be implemented in prisons and their costs. Individuals currently incarcerated who have recently used drugs and experienced trauma might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could significantly improve life after incarceration.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Processing Therapy (CPT) is a well-accepted treatment for posttraumatic stress disorder (PTSD). Studies have found that CPT can significantly reduce PTSD symptoms without causing major side effects. Participants in various trials have generally tolerated the therapy well, with few reports of serious negative effects.

For self-help therapy using a workbook, detailed safety information is limited, but it is generally considered low-risk. Self-help methods usually involve reading and practice exercises, which are typically safe and easy to follow. These methods allow participants to work at their own pace, reducing the chance of stress or negative reactions.

Both treatments aim to help individuals manage trauma and lessen related symptoms. Overall, existing evidence suggests that each approach can be safely used by those dealing with trauma-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognitive Processing Therapy (CPT) for PTSD because it offers a unique group therapy format, specifically adapted for use in prisons. Unlike traditional PTSD treatments, which often involve one-on-one therapy or medication, this approach allows participants to learn from shared experiences in a supportive group setting. The CPT-CJ version focuses on helping individuals change upsetting thoughts related to trauma, which can be particularly beneficial in a prison environment. Additionally, the study includes an option for individual trauma-focused self-help via a workbook, providing a flexible and independent approach to recovery. These diverse methods aim to offer more tailored and accessible PTSD treatment options.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Cognitive Processing Therapy (CPT), which participants in this trial may receive, effectively reduces symptoms of posttraumatic stress disorder (PTSD). Studies have found that CPT not only lessens PTSD symptoms but also improves related issues like depression and suicidal thoughts. For those in prison, an adapted version called CPT-CJ is expected to help with trauma and reduce drug use and crime after release.

Another treatment option in this trial is the use of a self-help workbook. Although evidence for this approach is more limited, it suggests some benefits for PTSD when individuals engage in trauma-focused therapy independently. The workbook helps participants learn and practice skills to manage trauma on their own, which might be beneficial for some. However, more research is needed to fully understand its effectiveness compared to group therapy. ^{2 6 7 8 9}

Who Is on the Research Team?

Melissa J Zielinski, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39908018/

Cognitive Processing Therapy for Posttraumatic Stress ... In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ... This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

3. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD To date, CPT has been shown to improve common comorbid symptoms and clinical correlates of PTSD such as depression (12,33), suicidal ideation (34), health- ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ... The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03808727

Massed Cognitive Processing Therapy for Combat-related ... This study will test the efficacy of massed CPT (MCPT) compared to standard CPT delivery. MCPT will be delivered in an intensive outpatient setting (12 sessions ...

6. ptsd.va.gov ptsd.va.gov/understand_tx/cognitive_processing.asp

Cognitive Processing Therapy (CPT) for PTSD The treatments that work best for PTSD are trauma-focused talk therapies. Trauma-focused therapy helps you work through the trauma and what it means to you.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0005789425000255

Exploring Structural Adaptations to Cognitive Processing ... Baig et al. (2021) found that group CPT achieved significant PTSD reductions compared to non-CPT treatment. In another study, although PTSD symptoms reduced ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11800015/

Cognitive Processing Therapy for Posttraumatic Stress ... Cognitive processing therapy (CPT) is an evidence-based treatment for posttraumatic stress disorder (PTSD). However, there is little evidence on ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07060144

Cognitive Processing Therapy (CPT) for Perinatal ... The research aims will be three-fold: (1) Evaluate the relative efficacy and tolerability of CPT vs. mCPT for treatment of perinatal PTSD and depression.