NCT05415735

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

June 8, 2022

Last Update Submit

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

EXPERIMENTAL

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

Interventions

This is a multimodal mind-body program designed to teach participants a variety of different strategies to reduce their physiologic stress response.

SMART Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Myocardial InfarctionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

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.

Locations