RECRUITINGINTERVENTIONAL

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

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - fluent English speaker. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States