Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

May 20, 2024 updated by: Michael T. Osborne, Massachusetts General Hospital

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive processing therapy
12 week treatment period of cognitive processing therapy followed by a post-treatment visit.
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
No Intervention: Control waitlist
Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial inflammation
Time Frame: Baseline and 12-weeks
Measured via FDG-PET imaging
Baseline and 12-weeks
Heart rate variability
Time Frame: Baseline and 12-weeks
Calculated from the average resting HRV collected at baseline and post-treatment visits
Baseline and 12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukopoiesis
Time Frame: Baseline and 12-weeks
Measured as bone marrow activity via FDG-PET imaging
Baseline and 12-weeks
Heart rate
Time Frame: Baseline and 12-weeks
Heart rate in beats per minute
Baseline and 12-weeks
Blood pressure
Time Frame: Baseline and 12-weeks
Systolic and diastolic pressure
Baseline and 12-weeks
MRI based arterial plaque components (such as necrotic tissue, loose connective tissue, and hemorrhage)
Time Frame: Baseline and 12-weeks
MRI measurements of atherosclerotic plaque components including necrotic tissue, loose connective tissue, and hemorrhage using black-blood imaging techniques
Baseline and 12-weeks
MRI based arterial wall thickness
Time Frame: Baseline and 12-weeks
Measurements of wall thickness as an assessment of atherosclerotic plaque
Baseline and 12-weeks
MRI based brain structure assessments of volume and density
Time Frame: Baseline and 12-weeks
Structural assessment of brain centers to assess volume and density of neural centers involved in the stress response
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)
Time Frame: Baseline and 12-weeks
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
MRI based brain activation (via measuring blood flow in important neural centers at rest and with an emotional task using functional MRI)
Time Frame: Baseline and 12-weeks
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
Axonal integrity of resting neural connections between brain centers using MRI
Time Frame: Baseline and 12-weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

American Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P001621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data from primary endpoints and analyses will be made available on a public website following study completion.

IPD Sharing Time Frame

Within 6 months of study completion

IPD Sharing Access Criteria

To be determined based on website used

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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