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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Heart Attack
• Intervention / Treatment: Behavioral: Stress Management and Resiliency Training Program

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMART Program; 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.	Behavioral: Stress Management and Resiliency Training Program; This is a multimodal mind-body program designed to teach participants a variety of different strategies to reduce their physiologic stress response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Myocardial Infarction; Cardiovascular Diseases
• Other Study ID Numbers: 1787419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No