Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study
Primary Purpose
Atherosclerosis, Stress, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Reduction
Sponsored by
About this trial
This is an interventional other trial for Atherosclerosis
Eligibility Criteria
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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stress Reduction
Control
Arm Description
8 week stress reduction course
No intervention
Outcomes
Primary Outcome Measures
Change in arterial inflammation by PET
Change in arterial inflammation based on FDG PET - from initial imaging to repeat imaging.
Secondary Outcome Measures
Full Information
NCT ID
NCT04496947
First Posted
July 29, 2020
Last Updated
April 17, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04496947
Brief Title
Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study
Official Title
Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Stress, Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups:
stress reduction intervention
no intervention
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stress Reduction
Arm Type
Experimental
Arm Description
8 week stress reduction course
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Stress Reduction
Intervention Description
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 Information:
Title
Change in arterial inflammation by PET
Description
Change in arterial inflammation based on FDG PET - from initial imaging to repeat imaging.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Tawakol, MD
Phone
6177243699
Email
atawakol@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Tawakol, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Tawakol, MD
Phone
617-724-3699
Email
atawakol@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study
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