Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06429293

Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

Led by Massachusetts General Hospital · Updated on 2025-09-25

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Impact of Cognitive Behavioral Therapy on PTSD-CVD Link

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Experienced trauma with clinically significant PTSD symptoms in at least two symptom clusters
  • Have subclinical or clinical atherosclerotic cardiovascular disease, or at least two risk factors such as hypertension, diabetes, high cholesterol, or active smoking
  • Able to understand and sign informed consent
  • Fluent in English
Not Eligible

You will not qualify if you...

  • History of stroke, brain surgery, or seizures
  • Use of certain cardiovascular medications such as beta-blockers, high-intensity statins, or PCSK-9 inhibitors
  • Changed psychiatric or cardiovascular medication within the past 4 weeks
  • Currently receiving PTSD therapy
  • Have neurological or systemic inflammatory diseases or currently using anti-inflammatory therapy
  • Have moderate or severe alcohol or substance use disorder
  • Have current mania or psychosis
  • Weigh more than 300 lbs., have claustrophobia, pregnancy, metal implants incompatible with MRI, or uncontrolled high blood sugar
  • Had significant radiation exposure for research purposes in the past 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

M

Michael Osborne, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Impact of Cognitive Behavioral Therapy on PTSD-CVD Link | DecenTrialz