Clinical trial NCT04496947: 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
Overall status: RECRUITING
Phase: NA
Conditions: Atherosclerosis
Stress
Inflammation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups:

1. stress reduction intervention
2. no intervention
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in arterial inflammation by PET
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Ahmed Tawakol, MD
role: PRINCIPAL_INVESTIGATOR
References: