Recruiting

Cognitive Behavioral Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT06429293

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive processing therapy

Study Details

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

Study ID

NCT06429293

Start date

Jul 1, 2023

Status verified date

Sep, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive processing therapy

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

no intervention: Control waitlist

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

Interventions

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

Primary outcome measure

  • Arterial inflammation [ Time Frame: Baseline and 12-weeks ]
  • Heart rate variability [ Time Frame: Baseline and 12-weeks ]

Central Contacts and Locations

Central contacts

Michael Osborne, MD

6177261843MOSBORNE@PARTNERS.ORG

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Osborne, MD

mosborne@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-09-25.