First Responder Resiliency Program During COVID-19

Stress Clinical Trial

Official title:

First Responder Resiliency Program for Health Care Professionals During a Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536376
• Other study ID #: 20-005017
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Resilience
• Sleep
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	PNMedical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Croghan IT, Hurt RT, Fokken SC, Fischer KM, Lindeen SA, Schroeder DR, Ganesh R, Ghosh K, Bausek N, Bauer BA. Stress Resilience Program for Health Care Professionals During a Pandemic: A Pilot Program. Workplace Health Saf. 2023 Apr;71(4):173-180. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress Scale	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

External Links

•   Citation link