Cognitive Processing Therapy for PTSD

Overseen By Michael Koenigs, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Alcohol, Cocaine, Opioids, others

Disqualifiers: Psychosis, Self-harm, Substance dependence, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Cognitive Processing Therapy can reduce PTSD (Post-Traumatic Stress Disorder) symptoms in individuals who have been incarcerated. Peer-led Trauma Therapy, led by group leaders with incarceration experience, involves attending a 6-week group treatment session. Suitable candidates for this trial are those who have completed a jail or prison sentence, experience PTSD symptoms, and are not currently dealing with psychosis or self-harm issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially benefit from a supportive therapy environment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a substance use dependence on certain drugs like alcohol or opioids, you may not be eligible to participate.

What prior data suggests that this therapy is safe for treating PTSD?

Research shows that Cognitive Processing Therapy (CPT) is a safe treatment for people with PTSD. In several studies, CPT improved PTSD and depression symptoms in various groups, including military veterans. One study noted that few participants discontinued CPT, indicating that most found it manageable. CPT also reduced PTSD symptoms in people with serious mental illnesses. Overall, CPT appears to be a dependable and well-tolerated treatment option for those dealing with PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about peer-led trauma therapy for PTSD because it introduces a community-based approach that empowers individuals with shared experiences to guide each other through recovery. Unlike traditional treatments such as cognitive-behavioral therapy or medications, this method emphasizes peer support, potentially increasing engagement and reducing stigma. This unique approach could enhance accessibility and offer a supportive environment that resonates with those who might feel isolated by conventional therapies.

What evidence suggests that Cognitive Processing Therapy is effective for treating PTSD in individuals impacted by incarceration?

Research has shown that Cognitive Processing Therapy (CPT), which participants in this trial may receive, effectively treats post-traumatic stress disorder (PTSD). One study demonstrated a noticeable decrease in PTSD symptoms, with a 14-point drop on a severity scale. Another study found that these improvements persisted, remaining strong from 17 to 34 weeks after treatment. A meta-analysis, which combines results from several studies, confirmed that CPT offers lasting benefits in various areas. This therapy helps people understand and change their thoughts about traumatic experiences, leading to fewer symptoms and improved mental health. ^{1 3 5 6 7}

Who Is on the Research Team?

Michael Koenigs, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been in prison or jail and are now dealing with PTSD. They must need treatment for PTSD, not be currently experiencing psychosis or actively harming themselves or feeling suicidal, and be willing to join group therapy.

Inclusion Criteria

You are not currently engaging in self-harming behaviors or have thoughts of harming yourself.

I am not experiencing symptoms of psychosis.

I am willing to join group therapy sessions.

Exclusion Criteria

You currently have a mental illness that affects your thoughts and behaviors.

You are currently engaging in self-harm or have thoughts of hurting yourself.

I have not been diagnosed with PTSD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a 6-week group Cognitive Processing Therapy (CPT) treatment for PTSD, consisting of 12 sessions.

6 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms and other mental health measures.

4.5 months

Post-treatment focus group or individual interview

What Are the Treatments Tested in This Trial?

Interventions

• Peer-led Trauma Therapy

Trial Overview The study tests Cognitive Processing Therapy in a group setting led by peers with similar incarceration experiences. It aims to see if this approach can reduce PTSD symptoms after a 6-week program among those affected by time spent in correctional facilities.

How Is the Trial Designed?

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

Groups of 6-8 receive CPT to treat PTSD

Peer-led Trauma Therapy is already approved in United States for the following indications:

Approved in United States as Peer-led Trauma Therapy for:

• Post-traumatic Stress Disorder (PTSD) in individuals impacted by incarceration

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

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]

The study aims to reduce dropout rates from prolonged exposure therapy for PTSD by providing peer support during in vivo exposure homework, with 150 veterans participating in a randomized controlled trial.

The effectiveness of this peer support approach will be measured by comparing treatment completion rates and PTSD symptom reduction between two groups: one receiving direct peer support during homework and another receiving general weekly check-ins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support during in vivo exposure homework to reverse attrition from prolonged exposure therapy for posttraumatic stress disorder (PTSD): description of a randomized controlled trial. Hernandez-Tejada, MA., Muzzy, W., Price, M., et al.[2021]

Manualized trauma-focused group therapy (TFGT) is presented as an effective alternative to individual cognitive-behavioral therapy for treating posttraumatic stress disorder (PTSD), focusing on directed exposure to traumatic memories.

The article outlines the cognitive-behavioral and developmental models behind TFGT, providing a structured approach to therapy that could enhance treatment efficiency and accessibility for individuals with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma focus group therapy for combat-related PTSD: an update. Foy, DW., Ruzek, JI., Glynn, SM., et al.[2018]

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]

A randomized clinical trial involving 135 patients will compare the online efficacy of trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP), and positive psychotherapy (PPT) in reducing PTSD symptoms during the COVID-19 pandemic.

The study aims to show that all three therapies can effectively reduce PTSD symptoms, anxiety, and depression, with no significant differences expected among them, highlighting the potential for flexible online treatment options for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol. Duran, ÉP., Hemanny, C., Vieira, R., et al.[2022]

In a study involving 291 adults with PTSD and/or substance use disorders, peer providers delivered the Seeking Safety (SS) program with similar effectiveness to licensed clinicians, showing non-inferiority in reducing PTSD symptoms and improving coping skills.

At 6 months, both peer-led and clinician-led groups experienced significant decreases in PTSD symptoms and increases in coping skills, suggesting that peer-delivered interventions could enhance access to mental health treatment, especially in underserved areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Peer-Delivered Trauma Treatment in a Rural Community: A Randomized Non-inferiority Trial. Crisanti, AS., Murray-Krezan, C., Reno, J., et al.[2020]

A pilot study involving 18 participants with probable PTSD showed that peer-delivered cognitive-behavioral therapy was feasible and highly acceptable, with participants reporting high satisfaction with the intervention.

The study found significant improvements in PTSD symptoms, as well as reductions in depressive, anxiety, and general stress symptoms, suggesting that peer support could effectively enhance access to mental health care in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer delivery of a brief cognitive-behavioral treatment for posttraumatic stress disorder: A hybrid effectiveness-implementation pilot study. Smith, AM., Stewart, K., Baul, T., 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]

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]

A 1-week intensive Cognitive Processing Therapy (CPT) for PTSD was found to be feasible and effective, leading to significant reductions in PTSD symptoms among seven trauma survivors interviewed after treatment.

Participants reported gaining tangible coping skills and reflected positively on the therapeutic process, indicating that intensive CPT can enhance cognitive and emotional coping strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Undoing a knot': a qualitative study of massed 1-week Cognitive Processing Therapy. Kovacevic, M., Tharaud, JB., Montes, M., et al.[2023]

Cognitive Processing Therapy (CPT) was associated with significant symptom improvement in combat veterans with PTSD, as shown by a multiple regression analysis of 61 participants, indicating its efficacy even among those who dropped out of treatment.

Among the treatment dropouts, some still experienced clinically significant improvements in their PTSD symptoms, suggesting that even partial engagement with CPT can lead to meaningful changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do early responders and treatment non-responders offer guidance to make CPT group a more effective treatment? Williams, MW., King-Casas, B., Chiu, PH., et al.[2023]

Citations

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

Cognitive Processing Therapy for Posttraumatic Stress ... The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in ...

2. 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 ...

3. 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.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ... These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

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

Cognitive Processing Therapy for PTSD Participants in the active treatment conditions (both CPT and PE) demonstrated significant improvement in PTSD and depression over the course of treatment as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3336190/

Long-Term Outcomes of Cognitive–Behavioral Treatments ... CPT and PE resulted in lasting changes in PTSD and related symptoms over an extended period of time for female rape victims with extensive histories of trauma.

7. 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.