First Responder Resiliency Program During COVID-19

NCT04536376 | Completed Results

• 1 other identifier: 20-005017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Resilience; Stress; Sleep

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Resilience Program

EXPERIMENTAL

a 4 week program focused on improving resilience

Behavioral: Resilience Program

Interventions

Resilience Program BEHAVIORAL

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.

Resilience Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• PNMedical: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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: 10.1177/21650799221093775. Epub 2022 Jul 5.

  PMID: 35787711 RESULT

Related Links

• Citation link

Results Point of Contact

• Title: Dr. Ivana T. Croghan
• Organization: Mayo Clinic

GIMRESEARCHSTUDIES@MAYO.EDU

507-284-2511

Study Officials

• Ivana T Croghan, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Brent Bauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, College of Medicine

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 2, 2020
• Study Start: January 15, 2021
• Primary Completion: September 2, 2021
• Study Completion: December 31, 2022
• Last Updated: May 13, 2024
• Results First Posted: May 13, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)