Evaluating how stress reduction affects heart health
Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study
This study tests if an 8-week program to reduce stress can help improve heart health by lowering inflammation in the arteries for adults dealing with high stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04496947 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of an 8-week mindfulness-based stress reduction program on atherosclerotic plaque inflammation in adults experiencing high levels of psychosocial stress. Participants will undergo baseline imaging using positron emission tomography (PET) and will be randomized into either a stress-reduction intervention group or a control group. The study aims to assess changes in arterial inflammation through follow-up imaging after the intervention. The approach combines understanding stress physiology with practical relaxation techniques and cognitive behavioral skills.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30-65 who identify as having high levels of stress and have a Perceived Stress Scale score greater than 5.
Not a fit: Patients with a Perceived Stress Scale score of 6 or lower may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new non-pharmacological strategies for reducing arterial inflammation and improving heart health in stressed individuals.
How similar studies have performed: Other studies have shown promising results in using stress reduction techniques to improve health outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Aged between 30-65 years * Identifies as having increased levels of stress and/or has a Perceived Stress Scale (PSS) score \>5 at baseline, and is interested in participating Exclusion Criteria: * Perceived Stress Scale (PSS) score \<6
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ahmed Tawakol, MD — Mgh
- Study coordinator: Ahmed Tawakol, MD
- Email: atawakol@mgh.harvard.edu
- Phone: 6177243699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.