Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

NCT06429293 | Recruiting

• 1 other identifier: 2023P001621
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Posttraumatic Stress Disorder

Keywords

Cardiovascular disease; Inflammation; Autonomic function; Stress-related neural activity

Outcome Measures

Primary Outcomes (2)

• Arterial inflammation

  Measured via FDG-PET imaging

  Baseline and 12-weeks

• Heart rate variability

  Calculated from the average resting HRV collected at baseline and post-treatment visits

  Baseline and 12-weeks

Secondary Outcomes (9)

• Leukopoiesis

  Baseline and 12-weeks

• Heart rate

  Baseline and 12-weeks

• Blood pressure

  Baseline and 12-weeks

• MRI based arterial plaque components (such as necrotic tissue, loose connective tissue, and hemorrhage)

  Baseline and 12-weeks

• MRI based arterial wall thickness

  Baseline and 12-weeks

Study Arms (2)

Cognitive processing therapy

EXPERIMENTAL

12 week treatment period of cognitive processing therapy followed by a post-treatment visit.

Behavioral: Cognitive processing therapy

Control waitlist

NO INTERVENTION

Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.

Interventions

Cognitive processing therapy BEHAVIORAL

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

Cognitive processing therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (47)

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Related Links

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

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michael Osborne, MD

CONTACT

6177261843; MOSBORNE@PARTNERS.ORG

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals who interpret images and data will be blinded to assigned intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Model Details: Participants are randomized to 12 weeks of cognitive processing therapy or waitlist control.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 24, 2024
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 6 months of study completion
• Access Criteria: To be determined based on website used

Locations

US (1)