NCT04505865

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease: A Multi-System PET/MRI Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled imaging study will be performed to evaluate the impact of mindfulness-based stress reduction via a mind body program on arterial inflammation in individuals with self-identified high levels of stress and stable coronary artery disease. Individuals will undergo baseline FDG-PET and magnetic resonance imaging (MRI) and will then be randomized to the stress-reduction intervention group or no intervention groups by blocks (1:1) with stratification by age and sex. The stress reduction sessions focus on developing an understanding of stress physiology and the physiology of the relaxation response, on developing a regular practice of eliciting the relaxation response, and on learning cognitive behavioral and positive psychology/resilience skills. During the screening period, patient acceptability for the study will be assessed based on medical history, concomitant medications, physical examination, and clinical laboratory test results. Acceptability for study participation will be confirmed for subjects who identify as having increased levels of stress and/or a Perceived Stress Scale (PSS) score \>=14. Once the patient has passed screening, they will undergo baseline imaging followed by randomization and group assignment. Approximately 12 weeks after randomization, all individuals will return for follow-up imaging and evaluation. FDG PET/MRI scans will be performed during the study for baseline and follow up to assess the intervention's impact on the brain as well as systemic and arterial inflammation along with other changes in related biomarker and imaging parameters. The Perceived Stress Scale will be delivered prior imaging during both imaging visits to measure perceived psychological stress. During both imaging sessions, subjects will be exposed to overt faces to measure signals during brain imaging.

Conditions

• Atherosclerosis
• Stress
• Inflammation

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2020-08-10
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States