Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429293
• Other study ID #: 2023P001621
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Michael Osborne, MD
• Phone: 6177261843
• Email: MOSBORNE[@]PARTNERS.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial inflammation	Measured via FDG-PET imaging	Baseline and 12-weeks
Primary	Heart rate variability	Calculated from the average resting HRV collected at baseline and post-treatment visits	Baseline and 12-weeks
Secondary	Leukopoiesis	Measured as bone marrow activity via FDG-PET imaging	Baseline and 12-weeks
Secondary	Heart rate	Heart rate in beats per minute	Baseline and 12-weeks
Secondary	Blood pressure	Systolic and diastolic pressure	Baseline and 12-weeks
Secondary	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	Baseline and 12-weeks
Secondary	MRI based arterial wall thickness	Measurements of wall thickness as an assessment of atherosclerotic plaque	Baseline and 12-weeks
Secondary	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	Baseline and 12-weeks
Secondary	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	Baseline and 12-weeks
Secondary	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	Baseline and 12-weeks
Secondary	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	Baseline and 12-weeks

External Links

•   About Multiple Cause of Death
•   The Life Events Checklist for DSM-5 (LEC-5)
•   The PTSD checklist for DSM-5 (PCL-5)