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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the research is to learn more about how to treat PTSD for people directly impacted by incarceration (i.e., have spent time in prison or jail). This research will help identify if a PTSD treatment group that is used in community settings, and led by individuals with lived experience, is helpful in reducing PTSD symptoms among people who have been directly impacted by incarceration. Participants will complete an interview to determine whether they are experiencing PTSD, and if so, will participate in a 6-week therapy group treatment.

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 data supports the effectiveness of the treatment Peer-led Trauma Therapy, Peer-led Trauma Therapy, Trauma-focused Group Therapy, Peer-facilitated Trauma Intervention for PTSD?

Research shows that having peer support during therapy can help people stick with their PTSD treatment, which often leads to better outcomes. Group cognitive processing therapy has been found to improve PTSD symptoms, and intensive therapy sessions can lead to significant symptom reductions and better coping skills. ^{1 2 3 4 5}

Is Cognitive Processing Therapy for PTSD safe for humans?

The research does not provide specific safety data for Cognitive Processing Therapy, but it suggests that peer-delivered trauma treatments, which include similar therapies, are feasible and acceptable, indicating they are generally safe for humans. ^{1 3 6 7 8}

How is Peer-led Trauma Therapy different from other PTSD treatments?

Peer-led Trauma Therapy is unique because it involves peers who have completed treatment helping others through the process, which may reduce dropout rates. This peer support aspect is not typically part of standard PTSD treatments like Cognitive Processing Therapy or Prolonged Exposure Therapy. ^{1 7 9 10 11}

Research Team

Michael Koenigs, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

1. England 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. [2021]

2. 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]

3. Switzerland 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. [2022]

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

'Undoing a knot': a qualitative study of massed 1-week Cognitive Processing Therapy. [2023]

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

Do early responders and treatment non-responders offer guidance to make CPT group a more effective treatment? [2023]

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

Effectiveness of Peer-Delivered Trauma Treatment in a Rural Community: A Randomized Non-inferiority Trial. [2020]

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

Trauma focus group therapy for combat-related PTSD: an update. [2018]

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

Peer delivery of a brief cognitive-behavioral treatment for posttraumatic stress disorder: A hybrid effectiveness-implementation pilot study. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. 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]

11. England pubmed.ncbi.nlm.nih.gov

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