Recruiting

Mindfulness

Sponsor:

Massachusetts General Hospital

Code:

NCT04505865

Conditions

Atherosclerosis

Stress

Inflammation

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Not accepted

Interventions

Stress Reduction

Study Details

Brief summary:

This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on atherosclerotic plaque inflammation in adults with stable coronary artery disease, as quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in individuals with increased psychosocial stress.

Conditions

Atherosclerosis

Stress

Inflammation

Study ID

NCT04505865

Start date

Nov 1, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must admit to feeling stressed and/or have PSS score > 13 (moderate stress)
  • Must be willing to complete stress reduction course and imaging sessions with < 3 missed appointments in last year
  • Known clinical cardiovascular disease with prior atherosclerotic myocardial infarction, percutaneous intervention or bypass surgery > 6 months before entry, or severe coronary calcifications on computed tomography or coronary calcium score >400
  • Stable symptoms without symptomatic heart failure or arrhythmia or planned revascularization
  • Maximally tolerated and stable medical regimen for 90 days that does not include a high intensity statin for clinical reasons
  • No neurological disease or systemic inflammatory disease/current anti-inflammatory therapy
  • No active psychiatric disease/medications or substance abuse (including tobacco smoking or more than moderate alcohol) for last 6 months
  • No current participation in cardiac rehab or prior participation in stress reduction
  • For imaging: no pregnancy, weight > 300 lbs., metal implants, uncontrolled hyperglycemia, or inability to provide consent or comply

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual care

Optimally tolerated medical therapy

experimental: Stress reduction

Optimally tolerated medical therapy and stress reduction course for 8 weeks

Interventions

Stress Reduction

The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session:

1\) Elicitation of the Relaxation Response through mind-body techniques; 2) discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and 3) coping strategies and adaptive perspective-taking to promote positive well-being.

Primary outcome measure

  • Change in arterial inflammation by PET imaging [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Michael T Osborne, MD

6176432114mosborne@mgh.harvard.edu

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

Mar 19, 2026

Last verified

Mar, 2026

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 2026-03-19.