Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Must not be taking: Beta-blockers, High-intensity statins

Disqualifiers: Stroke, Seizure, Alcohol use disorder, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a pilot randomized controlled trial to assess the impact of a first-line treatment for posttraumatic stress disorder (PTSD) (Cognitive Processing Therapy; CPT) versus waitlist control on mechanisms of cardiovascular disease (CVD) risk. Further, this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in stress-related neural activity (SNA)

Will I have to stop taking my current medications?

The trial requires that you do not change your psychiatric or cardiovascular medications within 4 weeks before starting, meaning you should be on a stable regimen. However, if you are taking certain CVD medications like beta-blockers or high-intensity statins, you may not be eligible to participate.

What data supports the effectiveness of the treatment Cognitive Processing Therapy (CPT) for Post-Traumatic Stress Disorder (PTSD)?

Cognitive Processing Therapy (CPT) has been shown to significantly reduce PTSD symptoms in various settings, including among women in residential treatment and sexual assault survivors, with improvements maintained for months. It is also widely used by the Department of Veterans Affairs, demonstrating solid improvements in PTSD and depression symptoms among veterans. ^{1 2 3 4 5}

Is cognitive processing therapy (CPT) safe for humans?

Cognitive processing therapy (CPT) is widely regarded as a safe treatment for post-traumatic stress disorder (PTSD) and has been implemented in various settings, including the Department of Veterans Affairs, with positive outcomes. It is considered a first-line treatment for PTSD and has been shown to be effective in reducing symptoms without significant safety concerns. ^{1 2 3 5 6}

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

Cognitive Processing Therapy (CPT) is unique because it focuses on helping individuals challenge and change unhelpful beliefs related to their trauma, using a structured approach that includes education, exposure, and cognitive components. It can be delivered in both group and individual formats, making it versatile for different settings and populations. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for individuals with PTSD to see if Cognitive Processing Therapy (CPT) can lower their risk of heart disease. Participants should be diagnosed with PTSD but not currently receiving CPT. There's no mention of specific exclusions, so general health requirements likely apply.

Inclusion Criteria

Ability to understand and sign informed consent

I have experienced a traumatic event and suffer from PTSD symptoms.

I have or am at high risk for heart artery disease.

Exclusion Criteria

I have a history of stroke, brain surgery, or seizures.

I have a neurological or systemic inflammatory disease and am on anti-inflammatory treatment.

Moderate/severe alcohol/substance use disorder

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete surveys, brain and peripheral imaging, and resting measures of autonomic function

1 week

1 visit (in-person)

Treatment

Participants receive Cognitive Processing Therapy (CPT) via telehealth

12 weeks

Weekly sessions (virtual)

Post-treatment Assessment

Participants attend a post-treatment visit with the same assessments as baseline

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cognitive Processing Therapy (Behavioral Intervention)

Trial Overview The study tests whether CPT, a common treatment for PTSD, can reduce the risk of cardiovascular disease by affecting inflammation and autonomic function, potentially influenced by stress-related neural activity.

Participant Groups

Group I: Cognitive processing therapy Experimental Treatment 1 Intervention

12 week treatment period of cognitive processing therapy followed by a post-treatment visit.

Group II: Control waitlist Active Control 1 Intervention

Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital Lead Sponsor

American Heart Association Collaborator

References

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

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. [2019] Cognitive processing therapy (CPT) is an exposure-based protocol designed to reduce posttraumatic stress disorder (PTSD) symptoms and challenge faulty beliefs and interpretations that prevent trauma survivors from coming to terms with their traumatic experiences. This article provides a brief summary of this treatment and the related literature and describes how the CPT protocol was modified to implement this treatment in this study's setting. Also provided is a discussion of various institutional and intrapatient barriers that existed before the introduction of CPT and how these difficulties were ultimately resolved. Patients' responses to treatment, as indicated by both qualitative and quantitative data, are also reviewed. A total of 18 patients participated and completed treatment with CPT (50% Caucasian, 22.2% African American, 16.7% biracial, 5.6% Native American, and 5.6% Hispanic). Overall, the women participating in the protocol benefited greatly, and 15 of the 18 women had a statistically significant reduction in scores measuring PTSD symptoms. The article concludes with recommendations to other programs and providers interested in providing CPT to similar treatment populations. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

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

Dissemination and experience with cognitive processing therapy. [2022] Clinical practice guidelines suggest that cognitive behavioral therapies are recommended for the treatment of posttraumatic stress disorder (PTSD). One of these treatments, cognitive processing therapy (CPT), is an evidence-based treatment that has been shown to be effective at treating combat, assault, and interpersonal violence trauma in randomized controlled trials. The Department of Veterans Affairs (VA) Office of Mental Health Services has implemented an initiative to disseminate CPT as part of a broad effort to make evidence-based psychotherapies widely available throughout the VA healthcare system. This article provides an overview of CPT and reviews the efficacy and program evaluation data supporting its use in a variety of settings. In addition, we report on survey data from individuals who have participated in the VA initiative and on outcome data from patients treated by rollout-trained therapists. Our data suggest that many clinicians trained in the rollout show good adoption of the CPT model and demonstrate solid improvements in their patients' PTSD and depressive symptomotology. Finally, we offer recommendations for using CPT in clinical settings.

3. 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] Cognitive processing therapy (CPT), an evidence-based treatment for posttraumatic stress disorder (PTSD), has not been tested as an individual treatment among active-duty military. Group CPT may be an efficient way to deliver treatment.

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

Cognitive processing therapy for sexual assault victims. [2022] Cognitive processing therapy (CPT) was developed to treat the symptoms of posttraumatic stress disorder (PTSD) in rape victims. CPT is based on an information processing theory of PTSD and includes education, exposure, and cognitive components. Nineteen sexual assault survivors received CPT, which consists of 12 weekly sessions in a group format. They were assessed at pretreatment, posttreatment, and 3- and 6-month follow-up. CPT subjects were compared with a 20-subject comparison sample, drawn from the same pool who waited for group therapy for at least 12 weeks. CPT subjects improved significantly from pre- to posttreatment on both PTSD and depression measures and maintained their improvement for 6 months. The comparison sample did not change from the pre- to the posttreatment assessment sessions.

5. England pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. [2023] Approximately ten percent of US military veterans suffer from posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) is a highly effective, evidence-based, first-line treatment for PTSD that has been widely adopted by the Department of Veterans Affairs (VA). CPT consists of discrete therapeutic components delivered across 12 sessions, but most veterans (up to 70%) never reach completion, and those who discontinue therapy receive only four sessions on average. Unfortunately, veterans who drop out prematurely may never receive the most effective components of CPT. Thus, there is an urgent need to use empirical approaches to identify the most effective components of CPT so CPT can be adapted into a briefer format.

6. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. [2019] Cognitive processing therapy (CPT) is widely regarded as a safe and effective first-line treatment for individuals with post-traumatic stress disorder (PTSD); however, no comparative studies have been conducted to examine the treatment outcomes in an Asian population. The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients.

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

Delivered as Described: A Successful Case of Cognitive Processing Therapy With an Older Woman Veteran With PTSD. [2023] Cognitive processing therapy (CPT) is a first-line, evidence-based treatment for posttraumatic stress disorder (PTSD). Little is known, however, about the use of CPT for older adults. As the United States population continues to grow and age, an understanding of the utility of CPT for older adults is vital. We present a case study describing the assessment and cognitive treatment of a 74-year-old woman veteran with PTSD secondary to military sexual trauma. CPT was associated with decreased PTSD symptoms as measured before and after treatment. Factors contributing to the veteran's response, as well as contextual and environmental factors, are discussed. The case demonstrates that CPT may be effective for older adults without major modification.