Recruiting

Stress Intervention

Sponsor:

Massachusetts General Hospital

Code:

NCT04496947

Conditions

Atherosclerosis

Stress

Inflammation

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Accepted

Interventions

Stress Reduction

Study Details

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

Atherosclerosis

Stress

Inflammation

Study ID

NCT04496947

Start date

Sep 1, 2018

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • Perceived Stress Scale (PSS) score <6

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Stress Reduction

8 week stress reduction course

no intervention: Control

No intervention

Interventions

Stress Reduction

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.

Primary outcome measure

  • Change in arterial inflammation by PET [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Ahmed Tawakol, MD

6177243699atawakol@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ahmed Tawakol, MD

6177243699atawakol@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 3, 2026

Last verified

Nov, 2025

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 2026-06-03.