First Responder Resiliency Program During COVID-19

December 5, 2023 updated by: Ivana T Croghan, PhD, Mayo Clinic

First Responder Resiliency Program for Health Care Professionals During a Pandemic

Evaluating a wellness program developed to provide effective sustainable solutions for medical professionals providing care to COVID-19 pandemic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Providing mindfulness training at specific time points during study participation with an emphasis on integrating physical and mental health management. The phase-based program delivers individualized, data-driven and quantifiable solutions that directly address pain points impacting healthcare professionals and organizations.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 18 years of age or older at the time of consent
  2. Frontline healthcare professional
  3. Have access to an Apple or Android device
  4. Not pregnant by subject self-report at time of consent
  5. Have the ability to provide informed consent
  6. Have no contraindicating comorbid health condition as determined by the clinical investigators

Exclusion Criteria:

  1. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis
  2. Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life or sleep
  3. Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, stress or sleep
  4. An unstable medical or mental health condition as determined by the physician investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resilience Program
a 4 week program focused on improving resilience
Behavioral: Resilience Program
Subjects receive program devices, and will be asked to wear during rest and sleep on a nightly basis along with active use during daytime. Notifications are sent daily, individualized approach developed and sent to participants to participate on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: 4 weeks
Perceived Stress Scale (PSS) is a 10-item Likert scale scoring system that measures global life stress by assessing the degree to which experiences are appraised as uncontrollable or unpredictable. Scores can range from 0 to 40, with higher scores indicating greater perceived stress. The outcome was analyzed as change from baseline
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

PNMedical

Investigators

  • Principal Investigator: Brent Bauer, MD, Mayo Clinic
  • Principal Investigator: Ivana T Croghan, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

September 2, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20-005017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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