The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04505865
Status
Recruiting
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Conditions

  • Atherosclerosis
  • Inflammation
  • Stress

Eligibility Criteria

Sex
ALL
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Stress Reduction — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2021
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Usual care
    Optimally tolerated medical therapy
  • Experimental: Stress reduction
    Optimally tolerated medical therapy and stress reduction course for 8 weeks

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Michael Osborne, MD
[email protected]

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By research site
Massachusetts General Hospital· Boston, MA

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