Cognitive Behavioral Therapy's Effect on PTSD and Heart Disease Risk

Impact of Cognitive Behavioral Therapy on Neural, Inflammatory, & Autonomic Markers in a Sample With PTSD and Cardiovascular Risk: Protocol for a Pilot Randomized Controlled Trial

This study is testing if Cognitive Processing Therapy can help people with PTSD lower their risk of heart disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06429293 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial evaluates the impact of Cognitive Processing Therapy (CPT) on individuals with Posttraumatic Stress Disorder (PTSD) and cardiovascular disease (CVD) risk. Participants are randomly assigned to receive CPT or be placed on a waitlist, with assessments conducted at baseline and after a 12-week treatment period. The study aims to understand how CPT may reduce CVD risk by influencing inflammation, autonomic function, and stress-related neural activity. Enrollment is ongoing, with a target of 30 participants from the Boston area.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with PTSD symptoms and subclinical or clinical cardiovascular disease risk factors.

Not a fit: Patients with a history of stroke, certain cardiovascular medication use, or currently undergoing PTSD therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel therapeutic approach to reduce cardiovascular disease risk in patients suffering from PTSD.

How similar studies have performed: While the specific approach of linking CPT to CVD risk is novel, previous studies have shown that cognitive behavioral therapies can positively impact mental health and related physical health outcomes.

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.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Michael Osborne, MD

Conditions Posttraumatic Stress Disorder; Cardiovascular disease; Inflammation; Autonomic function; Stress-related neural activity