NCT06429293 Impact of Cognitive Behavioral Therapy on PTSD-CVD Link
| NCT ID | NCT06429293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2026-07-01 |
Trial Parameters
Eligibility Fast-Check
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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)
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; *