ResilienceNCT04536376
First Responder Resiliency Program During COVID-19
A study testing Resilience Program in people with Resilience and Stress, run by Mayo Clinic at 1 site in United States.
Trial summary
Evaluating a wellness program developed to provide effective sustainable solutions for medical professionals providing care to COVID-19 pandemic patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience, Stress, Sleep
- What is being tested?
- Resilience Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Resilience, Stress, Sleep
- Being tested
- Resilience Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resilience Program | Experimental | a 4 week program focused on improving resilience Receives: Behavioral: Resilience Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start15 Jan 2021
- Primary completion2 Sep 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ResilienceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- PNMedical
- Responsible party
- Principal investigator, Ivana T Croghan, PhD, Mayo Clinic
- Investigators
- Ivana T Croghan, PhD, Principal investigator, Mayo ClinicBrent Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536376
- Sponsor's protocol ID
- 20-005017
- Status last verified
- Dec 2023
- First submitted
- 26 Aug 2020
- Last updated
- 13 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35787711
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Responder Resiliency Program for Health Care Professionals During a Pandemic
- ClinicalTrials.gov ID
- NCT04536376
- Acronym / sponsor ID
- 20-005017
- Conditions
- Resilience, Stress, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- PNMedical
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Posted 13 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating a wellness program developed to provide effective sustainable solutions for medical professionals providing care to COVID-19 pandemic patients.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resilience Program | Experimental | Behavioral: Resilience Programa 4 week program focused on improving resilience |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience ProgramSubjects 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. | Behavioural | Resilience Program |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35787711Croghan 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.
- Citation linkLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Resilience
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Not yet recruiting
Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses
Moral Injury
Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
Recruiting
A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship
Lymphoma
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana T Croghan, PhD principal investigator
Mayo Clinic
Brent Bauer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Program in people with Resilience and Stress, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.