Stress Management and Resiliency Training Following Acute Myocardial Infarction

• Sponsor: University of California, Davis (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05415735
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.7
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Attack; Cardiovascular Diseases	Behavioral: Stress Management and Resiliency Training Program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Total-Body PET Imaging to Understand the Physiology of Stress, Inflammation, and Meditation Following a Heart Attack
• Actual Study Start Date: May 11, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in amygdala activation [about 10 weeks]

   change in radiotracer uptake in the amygdala with FDG-PET imaging from before to after the SMART Program

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michelle Dossett, Assistant Professor of Medicine, University of California, Davis
• ClinicalTrials.gov Identifier: NCT05415735
• Other Study ID Numbers: 1787419
• First Posted: Jun 13, 2022
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases; Myocardial Infarction

Study Results

No Results Posted as of Jun 13, 2022