Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

NCT ID: NCT06429293

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-07-01

Brief Summary

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)

Detailed Description

This study is a randomized controlled trial of CPT compared to waitlist control that is testing the effects of CPT on mechanisms of the PTSD-CVD link. Enrollment began in 2023 and is projected to continue through 2026. Participants include individuals with PTSD and CVD risk recruited from the Boston area (N = 30). Treatment assignment is randomized and stratified by sex. Participants are randomized to CPT (n = 15) or waitlist control (n = 15). Potentially eligible participants complete a screening visit to confirm inclusion/exclusion criteria. Upon confirmation of eligibility, participants are scheduled for a baseline session, where they complete surveys, brain and peripheral imaging, and resting measures of autonomic function. Following the baseline visit, participants are randomized into CPT or the waitlist control group. Those randomized to CPT complete sessions via telehealth. Following a 12-week treatment period, participants attend the post-treatment visit, consisting of the same assessments administered at baseline. Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive processing therapy

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

Group Type: EXPERIMENTAL

Cognitive processing therapy

Intervention Type: BEHAVIORAL

The active intervention is Cognitive Processing Therapy (CPT) is a gold-standard cognitive behavioral therapy for PTSD. The CPT intervention consists of 12 60-minute sessions teaching skills to challenge trauma-relevant cognitions that are distorted or unhelpful. Trauma-relevant cognitions fall into five themes that are highlighted during treatment: safety, trust, power/control, esteem, and intimacy. The empirical base for CPT is strong with numerous studies demonstrating that it results in significant reduction of PTSD symptoms regardless of trauma type and that it is 89% more effective than control treatment. CPT has been successfully implemented in virtual formats with comparable efficacy levels to that of in-person CPT. CPT sessions for this study will be conducted virtually by a CPT-trained clinician

Control waitlist

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive processing therapy

The active intervention is Cognitive Processing Therapy (CPT) is a gold-standard cognitive behavioral therapy for PTSD. The CPT intervention consists of 12 60-minute sessions teaching skills to challenge trauma-relevant cognitions that are distorted or unhelpful. Trauma-relevant cognitions fall into five themes that are highlighted during treatment: safety, trust, power/control, esteem, and intimacy. The empirical base for CPT is strong with numerous studies demonstrating that it results in significant reduction of PTSD symptoms regardless of trauma type and that it is 89% more effective than control treatment. CPT has been successfully implemented in virtual formats with comparable efficacy levels to that of in-person CPT. CPT sessions for this study will be conducted virtually by a CPT-trained clinician

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 18-65 years (upper limit chosen to optimize changes in brain activation that diminish with age);
• criterion A trauma exposure and PTSD symptoms (clinically significant symptoms in at least two symptom clusters);
• subclinical atherosclerotic CVD (e.g., coronary, cerebrovascular, or peripheral arterial plaque or calcifications on imaging), clinical atherosclerotic CVD (e.g., myocardial infarction or revascularization), or increased risk for atherosclerotic CVD (i.e., >2 of hypertension, diabetes mellitus, hyperlipidemia, and active smoking) ability to understand and sign informed consent
• fluent English speaker.

Exclusion Criteria

• history of stroke, brain surgery, seizure
• use of certain CVD medications (e.g., beta-blockers, high-intensity statins [e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg], PCSK-9 inhibitors);
• psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed);
• currently in PTSD therapy;
• neurological or systemic inflammatory disease/current anti-inflammatory therapy;
• moderate/severe alcohol/substance use disorder;
• current mania/psychosis;
• weight >300 lbs., claustrophobia, pregnancy, metal implants that are incompatible with magnetic resonance imaging (MRI), or uncontrolled hyperglycemia (for imaging);
• significant radiation exposure (>2 nuclear tests, computed tomography images, or fluoroscopic procedures) for research purposes during the preceding 12-months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael T. Osborne

Clinician Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Osborne, MD

Role: CONTACT

MOSBORNE@PARTNERS.ORG

6177261843

Facility Contacts

Michael Osborne, MD

Role: primary

mosborne@mgh.harvard.edu

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Related Links

https://wonder.cdc.gov/mcd-icd10.html

About Multiple Cause of Death

https://www.ptsd.va.gov/professional/assessment/te-measures/life_events_checklist.asp

The Life Events Checklist for DSM-5 (LEC-5)

https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp

The PTSD checklist for DSM-5 (PCL-5)

Other Identifiers

2023P001621

Identifier Type: -

Identifier Source: org_study_id