Home › Post-Traumatic Stress Disorder › NCT06429293
Impact of Cognitive Behavioral Therapy on PTSD-CVD Link
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
Who can join
Ages 18 to 65 · All sexes
Full 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.
About the study
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)
What is being tested
- Cognitive processing therapy (behavioral)
Sponsor: Massachusetts General Hospital · Participants: 30 · Started: Jul 1, 2023
Contact the study team
- Michael Osborne, MD · Phone: 6177261843
Official record on ClinicalTrials.gov — NCT06429293
Locations in the U.S.
| Massachusetts | Massachusetts General Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.