Back to resultsStress Management and Resiliency Training Following Acute Myocardial Infarction
Primary Purpose
Heart Attack, Cardiovascular Diseases
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Management and Resiliency Training Program
Sponsored by
About this trial
This is an interventional basic science trial for Heart Attack
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of California Davis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMART Program
Arm Description
The 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.
Outcomes
Primary Outcome Measures
Change in amygdala activation
change in radiotracer uptake in the amygdala with FDG-PET imaging from before to after the SMART Program
Secondary Outcome Measures
Full Information
NCT ID
NCT05415735
First Posted
June 8, 2022
Last Updated
June 14, 2023
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT05415735
Brief Title
Stress Management and Resiliency Training Following Acute Myocardial Infarction
Official Title
Total-Body PET Imaging to Understand the Physiology of Stress, Inflammation, and Meditation Following a Heart Attack
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Attack, Cardiovascular Diseases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMART Program
Arm Type
Experimental
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management and Resiliency Training Program
Intervention Description
This is a multimodal mind-body program designed to teach participants a variety of different strategies to reduce their physiologic stress response.
Primary Outcome Measure Information:
Title
Change in amygdala activation
Description
change in radiotracer uptake in the amygdala with FDG-PET imaging from before to after the SMART Program
Time Frame
about 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Stress Management and Resiliency Training Following Acute Myocardial Infarction
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