Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study

NCT04496947 | Recruiting DMC

• 1 other identifier: 2017P000706
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography (PET) with fluorine-2-deoxy-D-glucose (FDG) in individuals with increased psychosocial stress.

Conditions

Stress; Inflammation; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in arterial inflammation by PET

  Change in arterial inflammation based on FDG PET - from initial imaging to repeat imaging.

  2 months

Study Arms (2)

Stress Reduction

EXPERIMENTAL

8 week stress reduction course

Behavioral: Stress Reduction

Control

NO INTERVENTION

No intervention

Interventions

Stress Reduction BEHAVIORAL

The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session: * Elicitation of the Relaxation Response (RR) through mind-body techniques; * Discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and * Coping strategies and adaptive perspective-taking to promote positive well-being.

Stress Reduction

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Perceived Stress Scale (PSS) score \<6

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Inflammation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ahmed Tawakol, MD

  MGH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Tawakol, MD

CONTACT

6177243699; atawakol@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Nuclear Cardiology

Model Details: 2 groups: 1. stress reduction intervention 2. no intervention

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: September 1, 2018
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-11

Locations

US (1)