Impact of Cognitive Behavioral Therapy on PTSD-CVD Link
Recruiting now · Not applicable
Conditions studied: Posttraumatic Stress Disorder
In brief
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)
Key facts
- Study ID
- NCT06429293
- Run by
- Massachusetts General Hospital
- People needed
- 30
- Starts
- 2023-07-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2025-09-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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