Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study
NCT ID: NCT04496947
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2018-09-01
2026-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. stress reduction intervention
2. no intervention
OTHER
SINGLE
Study Groups
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Stress Reduction
8 week stress reduction course
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.
Control
No intervention
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
65 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Ahmed Tawakol
Director, Nuclear Cardiology
Principal Investigators
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Ahmed Tawakol, MD
Role: PRINCIPAL_INVESTIGATOR
MGH
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Ahmed Tawakol, MD
Role: primary
Other Identifiers
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2017P000706
Identifier Type: -
Identifier Source: org_study_id