The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

NCT ID: NCT04505865

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care

Optimally tolerated medical therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Stress reduction

Optimally tolerated medical therapy and stress reduction course for 8 weeks

Group Type: EXPERIMENTAL

Stress Reduction

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SMART-3RP

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael T. Osborne

Instructor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael T Osborne, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael T Osborne, MD

Role: CONTACT

Phone: 6176432114

Email: mosborne@mgh.harvard.edu

Facility Contacts

Michael Osborne, MD

Role: primary

Other Identifiers

2020A002750

Identifier Type: -

Identifier Source: org_study_id