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)
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 scheduled for a baseline session, where they complete surveys, brain and peripheral imaging, and resting measures of autonomic function. Following the baseline visit, participants are randomized into CPT or the waitlist control group. Those randomized to CPT complete sessions via telehealth. Following a 12-week treatment period, participants attend the post-treatment visit, consisting of the same assessments administered at baseline. Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGArterial inflammation
Measured via FDG-PET imaging
Time frame: Baseline and 12-weeks
Heart rate variability
Calculated from the average resting HRV collected at baseline and post-treatment visits
Time frame: Baseline and 12-weeks
Leukopoiesis
Measured as bone marrow activity via FDG-PET imaging
Time frame: Baseline and 12-weeks
Heart rate
Heart rate in beats per minute
Time frame: Baseline and 12-weeks
Blood pressure
Systolic and diastolic pressure
Time frame: Baseline and 12-weeks
MRI based arterial plaque components (such as necrotic tissue, loose connective tissue, and hemorrhage)
MRI measurements of atherosclerotic plaque components including necrotic tissue, loose connective tissue, and hemorrhage using black-blood imaging techniques
Time frame: Baseline and 12-weeks
MRI based arterial wall thickness
Measurements of wall thickness as an assessment of atherosclerotic plaque
Time frame: Baseline and 12-weeks
MRI based brain structure assessments of volume and density
Structural assessment of brain centers to assess volume and density of neural centers involved in the stress response
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Time frame: Baseline and 12-weeks
MRI based brain connectivity (by measuring changes in blood flow across networks of neural centers at rest and with an emotional task)
Connectivity assessment using mapping on functional MRI at baseline and in response to emotional faces of neural centers involved in the stress response to determine the interplay between neural centers before and after therapy by measuring alterations in blood oxygen content under various conditions in different parts of the brain
Time frame: Baseline and 12-weeks
MRI based brain activation (via measuring blood flow in important neural centers at rest and with an emotional task using functional MRI)
Activation assessment using functional MRI at both rest and in response to emotional faces of neural centers involved in the stress response before and after therapy by measuring blood flow under various conditions to different parts of the brain
Time frame: Baseline and 12-weeks
Axonal integrity of resting neural connections between brain centers using MRI
Measurement of axonal integrity using diffusion tensor imaging on MRI to determine the strength connections between important brain centers and neural networks related to stress perception in PTSD before and after therapy
Time frame: Baseline and 12-weeks