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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496947
• Other study ID #: 2017P000706
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: August 30, 2025

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: Ahmed Tawakol, MD
• Phone: 6177243699
• Email: atawakol[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. Individuals will undergo baseline Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging and will then be randomized to the stress-reduction intervention group or no intervention groups by blocks of 2:1, 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 score >5. 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. Thus, 2 Fluorodeoxyglucose-Positron emission tomography / magnetic resonance imaging scans will be performed throughout the study for baseline and follow up to assess the intervention's impact on the brain and arterial inflammation, along with changes in related positron emission tomography / magnetic resonance imaging imaging parameters. Perceived Stress Scale will be delivered prior to Fluorodeoxyglucose-Positron emission tomography / magnetic resonance 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation
• Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arterial inflammation by PET	Change in arterial inflammation based on FDG PET - from initial imaging to repeat imaging.	2 months