Impact of Cognitive Behavioral Therapy on PTSD-CVD Link
Launched by MASSACHUSETTS GENERAL HOSPITAL · May 20, 2024
Trial Information
Current as of February 18, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a type of therapy called Cognitive Processing Therapy (CPT) can help people with Posttraumatic Stress Disorder (PTSD) and possibly reduce their risk of heart disease. Researchers want to find out if this therapy can lower inflammation and improve heart function by reducing stress-related brain activity. The trial is currently looking for participants aged 18 to 65 who have experienced trauma and have PTSD symptoms, along with some heart disease risk factors.
If you decide to participate, you will be randomly assigned to receive either the therapy or be placed on a waitlist for it. Those in the therapy group will learn techniques to manage their PTSD, and researchers will monitor changes in their heart health throughout the study. It’s important to know that some individuals may not qualify due to specific health conditions or treatments. Overall, this study aims to improve understanding of how treating PTSD can benefit heart health.
Gender
ALL
Eligibility criteria
- 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.
About Massachusetts General Hospital
Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0