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
Massachusetts General Hospital
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)
Description
This study is a randomized controlled trial of CPT compared to waitlist control that is testing the effects of CPT on mechanisms of the PTSD-CVD link. Enrollment began in 2023 and is projected to continue through 2026. Participants include individuals with PTSD and CVD risk recruited from the Boston area (N = 30). Treatment assignment is randomized and stratified by sex. Participants are randomized to CPT (n = 15) or waitlist control (n = 15). Potentially eligible participants complete a screening visit to confirm inclusion/exclusion criteria. Upon confirmation of eligibility, participants are…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BehavioralCognitive 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
Location
- Massachusetts General HospitalBoston, Massachusetts