Stress Management and Resiliency Training Following Acute Myocardial Infarction
Total-Body PET Imaging to Understand the Physiology of Stress, Inflammation, and Meditation Following a Heart Attack
1 other identifier
interventional
10
1 country
1
Brief Summary
The goal of this pilot study is to use total body PET/CT imaging to examine the relationships between stress, amygdala activation, and arterial wall inflammation in participants before and after participating in a multi-modal stress reduction program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2022
CompletedFirst Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedMay 21, 2024
May 1, 2024
7 months
June 8, 2022
May 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in amygdala activation
change in radiotracer uptake in the amygdala with FDG-PET imaging from before to after the SMART Program
about 10 weeks
Study Arms (1)
SMART Program
EXPERIMENTALThe Stress Management and Resiliency Training (SMART) Program is a multimodal mind-body and cognitive skills-based program that teaches participants a variety of different approaches for reducing their physiologic stress response. The program is delivered virtually (online) for 1.5 hours once a week for 8 weeks.
Interventions
This is a multimodal mind-body program designed to teach participants a variety of different strategies to reduce their physiologic stress response.
Eligibility Criteria
You may qualify if:
- Concurrently enrolled in an observational study of patients who have had an acute myocardial infarction
- Score on PSS-10 of 14 or greater during screening
- Willing and able to access the internet to participate in the online SMART Program
You may not qualify if:
- Poorly controlled physical or mental health condition that would likely interfere with the ability to participate in SMART or ability to undergo PET scan
- Current daily practice of meditation of 10 minutes or more per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Davis
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 13, 2022
Study Start
May 11, 2022
Primary Completion
December 8, 2022
Study Completion
October 1, 2023
Last Updated
May 21, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
Interested researchers need to submit a written request for access to data which will be reviewed internally. If approved, a data sharing agreement will need to be created.