First Responder Resiliency Program for Health Care Professionals During a Pandemic
Phase: NA
Conditions: Resilience, Stress, Sleep
Sponsor: Mayo Clinic

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
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First Responder Resiliency Program for 
Health Care Professionals During a 
Pandemic 
 
Study Protocol 
 
 
NCT04536376 
 
 
 
12/15/2020 
 

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
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General Study Information 
 
Principal Investigator:      Ivana T. Croghan, PhD and Brent A. Bauer, MD 
 
 
 
 
Study Title:  First Responder Resiliency Program for Health Care Professionals During a Pandemic  
 
Protocol version number and date:   Version 4, December 15, 2020 
 
Research Question and Aims 
 
Hypothesis  
 
Healthcare professionals on the frontline of care can experience work-related environmental factors that lead to likely 
increased moral injury and staff turnover. We postulate that an integrative resiliency training program (i.e. First 
Responder Resiliency Program) will improve physical and mental health parameters in frontline healthcare professionals. 
 
Aims, purpose or objectives 
 
The purpose of this study is to evaluate the feasibility of a resiliency program to provide an effective and sustainable 
solution to medical professionals experiencing high levels of stress while delivering frontline healthcare.  With an 
emphasis on integration of mental and physical health management, the phase-based program delivers individualized, 
data-driven and quantifiable solutions that directly address pain points impacting healthcare professionals and 
organizations. We plan to study 10 healthcare professionals using a specifically designed resiliency program where data is 
passively captured from a finger-worn sensor that the participant wears nightly during sleep.  
 
1. To study the feasibility of an individualized First Responder Resiliency Program in providing performance 
breathing interventions and stress inoculations to healthcare professionals. 
 
The primary outcomes will be:  
1) The quantifiable improvements in Perceived Stress, and Resilience Scale in frontline healthcare providers at 
specific time points during their participation in the First Responder Resiliency Program 
 
Objective 
 
Through an integrative approach that addresses physical and mental health parameters through rapid and sustainable 
interventions, the First Responders Resiliency Program will deliver objective and quantifiable improvements in the areas 
of stress resilience, sleep efficiency, and immune function. Work productively, engagement and reduced physician 
turnover are key performance indicators of program success, our objective is to deliver results that improve employee joy 
in their work and personal lives. 
 
Background  
 
Stress, exposure to infectious agents and inadequate sleep are inevitable components of daily life for frontline healthcare 
professionals. While these individuals dedicate their time and effort towards providing care to others, they often 
experience negative outcomes in their own physical and mental health leading to a high prevalence of moral injury and 
staff turnover. In addition to the approximately $4.6B annual cost to the US healthcare system1, staff turnover rate is 
associated with the high prevalence of suicide among healthcare workers in the US, compared to other countries2. 
 
With the recent COVID-19 pandemic, these work-related environmental factors will likely lead to increased moral injury 
and staff turnover for healthcare professionals. In the population of healthcare professionals where exposure can be 

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
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difficult to avoid, it is important to focus on proactive, sustainable and validated physical and mental health solutions that 
address stress resilience and recovery with an emphasis on early detection and intervention. 
 
Study Design and Methods 
 
Methods  
 
This is an open intervention clinical trial. Study participants will participate in an individualized program through an 
integrative approach that addresses physical and mental health parameters through rapid and sustainable interventions.  
Study involvement will last approximately 4 weeks. 
 
We will assess the following: 
 
• 
Comprehensive sleep analysis, heart rate, heart rate variability, respiratory rate, and temperature through the use 
of the Oura Ring finger-worn sensor worn nightly during sleep sessions.  
 
• 
Assess changes in Sleep Quality Assessment, Perceived Stress, and Resilience Scale, measured at baseline and 
end of study. 
 
Data Collection 
 
• 
Subjects will complete study surveys/questionnaires through REDCap.  The coordinator can provide the Ipad 
digital or paper copy version of the survey/questionnaire to the subject for the in-person visits and by email link or 
phone interview for the remote visits.   
 
• 
Survey data collection in this study will utilize REDCap3.  The only anticipated paper source documents will be if 
subject chooses to complete surveys via paper copy or phone collection, which will then have select variables 
entered directly into the REDCap data entry system.  All other data collection will be entered directly into this 
password protected system.   
 
• 
Intervention data will be collected through the developer, (PN Medical and Oura) with use of the Oura Ring 
finger-worn sensor device and the phone application that the subject has the option to use. Data sharing between 
Mayo Clinic, PN Medical and Oura. Adherence to the Respiratory Muscle Training (RMT) interventions will be 
collected through a daily diary. 
 
Visit Flow and Timeline 
 
 
Consent 
Baseline 
Intervention Phase 
End of Study 
Visit Number 
V0 
V1 
 
 
 
V2 
Visit Week 
0 
1 
2 
3 
4 
End of Week 4 
Informed Consent 
X1 
 
 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
 
 
Oura ring (Measure size & Video) 
X2 
 
 
 
 
 
Create study email 
 
X 
 
 
 
 
Oura App registry by Subject 
 
X 
 
 
 
 
Receive intervention tools 
 
X3 
 
 
 
 
Cardiorespiratory Fitness  
 
X8 
 
 
 
X8 
Questionnaires4: 
Sleep Quality Assessment (PSQI) 
X 
 
 
 
 
X 
Perceived Stress Scale (PSS) 
X 
 
 
 
 
X 
Brief Resilience Scale (BRS) 
X 
 
 
 
 
X 

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
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Depression (PHQ2) 
X 
 
 
 
 
X 
Demographics Form 
X 
 
 
 
 
 
Satisfaction Survey (WIWI) 
 
 
 
 
 
X 
Education: 
90 minute intro session 
 
X9 
 
 
 
 
Intervention: 
Oura5 
 
X 
X 
X 
X 
 
Breather Fit Device6 
 
 
X 
X 
X 
 
Breather Fit Use Diary (RMT) 
 
 
X 
X 
X 
 
Stress Inoculation7 
 
 
X 
X 
X 
 
Optional Group Collaboration 
 
 
X 
X 
X 
 
Weekly Scorecard 
 
 
X 
X 
X 
 
Continuous monitoring, insights & 
adjustments by PNMedical 
 
X 
X 
X 
X 
 
 
1 Consent can be completed digitally in person or through remote consenting. 
2 Subject will contact study team member with ring size that they would like request ordered. Rings will be shipped to 
study team for dispensing to subject at baseline visit. 
3 Subject receive items and introduction on care and use. 
4 Surveys can be completed digitally through an Ipad, in person, or a link sent to the subject’s chosen email address. 
5 Oura Ring to be worn on subject’s finger on nightly basis during rest or sleep. 
6 Use as directed for Respiratory Resilience Program. 
7 Performance Breathing Interventions, mobility exercises, and muscle activation.  
8 Subject will self-report distance walked and steps taken for this fitness test. 
9 Intro session will be scheduled with PN Medical collaborators, approximately 1 week after receiving study supplies (a 
minimum of 5 days of wearing device for baseline data). 
 
Assessments  
 
Outcomes:  
• 
Demographics Form:  This form collects demographic and other lifestyle history of the research subject. 
• 
Stress:  Will be evaluated through the Perceived Stress Scale (PSS)4,5. The 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. Reliability is reported as 0.85, with Cronbach alphas ranging from 0.75-0.86. 
• 
Resilience: Will be evaluated through the Brief Resilience Scale (BRS) Scale6.  This is a 6-item Likert scale 
validated scoring system.   The BRS is a reliable means of assessing resilience as the ability to bounce back or 
recover from stress. 
• 
Sleep Quality: The Pittsburgh Sleep Quality Index (PSQI)7 is an effective instrument used to measure the quality 
and patterns of sleep in adults. This is a 9-item Likert scale validated scoring system.  It differentiates “poor” from 
“good” sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep 
duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over 
the last month. 
• 
Depression:  For this measure we will use the PRIME-MD Questionnaire8,9 which is a validated and frequently 
used self-report measure of depressive symptoms comprising of 2 questions, which was derived from the 
PHQ10,11.  
• 
Satisfaction with the program: Was it Worth it Questionnaire (WIWI)12: This satisfaction survey will be 
administered to the participants prior to completing intervention at the end of the study, probing their satisfaction 
with the research study. These data could be used to assess the feasibility of the intervention by asking the patient 
if the entire research experience was worth it for them. 
• 
Biometrics:  Trend analysis of comprehensive de-identified sleep data, heart rate, heart rate variability, and 
respiratory rate will be collected through the use of the Oura Ring device and provided by PN Medical. 

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
Page 5 of 9 
 
Adherence to Intervention: 
• 
Adherence to the Oura device will be assessed by de-identified data available from Oura and PN Medical. 
• 
Adherence to Breather Fit device will be assessed by de-identified data available from Oura and PN Medical and 
subject self-report diary  
 
Intervention:  
• 
Breather Fit Device:  This device is used for activation and build-up of the pulmonary system for optimization and 
strengthening of the respiratory muscle system for better pulmonary hygiene and improved cardiopulmonary 
function. Stress has a direct impact on immune and inflammatory responses, reducing the body’s ability to fight 
infections. Furthermore, the pulmonary system is an important contributor as the upper airway serves as an entry 
passage for respiratory pathogens including viral and bacterial infectious agents. 
Therefore, optimizing airway clearance of secretions/pulmonary hygiene may 
offer an additional defense against unwanted microorganisms, mitigating their 
potential impact on the respiratory tract microbiome and risk for lower 
respiratory tract infections. 
 
The Breather Fit is a respiratory device made of medical grade plastic and is for 
oral use. It has to be cleaned ac-cording to the instructions 
(https://www.pnmedical.com/lessons/breather-fit-cleaning/) after every use to 
avoid contamination. In addition, hands should be washed for 30 seconds 
before use of the device. To avoid spreading of saliva droplets, the device 
should be used at a distance of 12 feet of other device users or persons.  
  
 
 
 
 
 
 
 
• 
Oura Ring: The Oura device with Application collects and summarizes health data into three meaningful scores 
(Readiness, Sleep, Activity) that help harness the body’s potential every day. Using infrared LEDs, NTC 
temperature sensors, an accelerometer, and a gyroscope, the Oura ring captures distinct parameters during the day 
and night, respectively.  
 
 
• 
Cardiovascular Assessment: The 6 and 12 minute performance test created by KH Cooper is an objective measure 
of physical fitness and reflects oxygen uptake efficiency and cardiovascular status 
(https://erj.ersjournals.com/content/37/1/150, https://jamanetwork.com/journals/jama/article-abstract/337382). 
Study participants will perform a test to assess the distance covered by walking or running in 6 minutes. Results 
can be converted into estimates of VO2 max, and can be compared to reference values. The cardiovascular 
assessment will be performed before and after the RMT intervention.  

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
Page 6 of 9 
• 
Optional Group Collaboration:  Participants have the option of sharing their biometric data with colleagues in a 
confidential de-identified daily or weekly posting of scores for ongoing motivation, competition and education of 
best practices.   
   
Subject Retention 
Participants will be offered all the intervention materials (i.e. Oura Ring finger-worn sensor, Breather Fit device and 
continued use of the app) utilized at the end of the study, so that they may continue use post study evaluation, if they so 
wish. 
 
 
 
Study Design 
We will use standardized procedures to ensure uniform instructions and support for all subjects for the recruitment, 
screening, and study entry.   
 
Recruitment 
Subjects will be recruited from Mayo Clinic healthcare professionals assisting in frontline care of patients.  We propose to 
recruit, consent and screen 15 participants through IRB approved contact materials in order to enroll 10 to study. All 
participants who respond to the recruitment message will be pre-screened for inclusion and exclusion criteria via a 
telephone pre-screen.  Those who meet criteria will be invited to a consent visit followed by a study screening visit.  After 
consent and screening has taken place, subjects who meet all study entry criteria will be invited to participate in the study.  
 
Consent and Screen 
Study coordinator will discuss with the potential subject who has expressed an interest in participating in the study.  The 
study coordinator will begin by introducing the study details, and after determining that the subject has continued interest 
in study participation, will move on to the study consent.  If the subject chooses to consent, the study coordinator will 
screen the participant for study entry inclusion/exclusion criteria.  If study entry criteria are met, the subject will begin 
their study participation. They will be asked to complete the study surveys/questionnaires, and be given the Oura ring 
sizer. The ring sizer is used to assist in measuring a finger size, and the participant would ideally wear the sizer on the 
finger that they choose to wear the Oura ring on for the study for 24 hours. Participants will be offered a short video 
explaining use and maintenance of the Oura ring, and a short overview of what the device measures (heart rate, heart rate 
variability, sleep phases, activity). The participant will self-report to a study team member the ring size they would like 
ordered for them. The study team member will order and receive the ring for delivery to subject at Baseline.  
 
Baseline Phase (week 1): 
A study coordinator will meet in person with the subject to begin the Baseline phase of the study.  The subject will be 
instructed on how to sign up for the Oura intervention application and given the study intervention materials, such as their 
Oura Ring, and Breather Fit device, and daily diary.  They will be instructed on the care and cleaning of these devices. 
 
Subjects will also be walked through the process of signing up for an email address to use for this study. 
 
Please note, the participant will sign up for the Resiliency Program (APP) on their own since the program is external to 
Mayo Clinic. De-identified data collected by the program from the study subjects will be shared with Mayo study team for 
analysis. 
 
In order to develop an individualized approach, it is important to assess beyond physical parameters and into the root 
cause of population-specific dysfunction, often related to the nervous systems. The Physician Resiliency Program begins 
with a minimum five-day baseline utilizing clinically reliable biometric collection in a natural environment to ensure data 
integrity. 
 
The study subjects will be scheduled to participate in a 90 minute kick-off meeting to receive an educational overview of 
the First Responder Resiliency Program.   
 

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
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Study participants will be asked to undergo a cardiorespiratory fitness test for VO2 Max assessment utilizing the Oura app 
by walking for 6-12 minutes while walking on a treadmill or wearing a pedometer, and then self-reporting the distance or 
steps covered during this time. 
 
Study participants will be requested to not modify any existing lifestyle habits to gain an accurate understanding of 
biometric trends during the baseline phase. 
 
Subjects will be asked to wear the Oura Ring device during rest and sleep time.  
 
Run In Phase (week 1): 
Participants will then be instructed to use the Oura ring (Run-In Phase 5 days minimum) prior to initiating the Educational 
Phase. 
 
Education Phase (end of week 1, beginning of week 2): 
The Kickoff educational virtual meeting will be scheduled individually with each study participant.  This meeting will 
begin with a short live introduction from PN Medical representative, then participants will view pre-recorded discussions 
about varying topics (background, user instructions, and training protocol for using the Breather Fit device; situational 
breathing strategies (SBS) for stress inoculation), and end with a live Q & A session where subjects can discuss the 
intervention and ask questions.  Various topics will include the following: 
 
• 
PN Medical- Paul DiTuro will discuss an overview of specific stress resilience tools and interventions, and review 
demonstration and practical application of muscle activation techniques utilized in Special Force Operators, 
professional athletes and corporate executives to prepare for stressful situations.  
• 
PN Medical Chief Scientist Dr. Nina Bausek will cover the comprehensive review of organization-level biometric 
trends and introduction of validated interventions related to cardiorespiratory fitness and nervous system 
management, and will give an introduction to proactive approaches to optimize stress resilience and immune 
function through conscious breathing, respiratory muscle training, and pulmonary hygiene.  
• 
PN Medical David Jack will discuss feature a series of videos explaining and demonstrating the situational 
breathing interventions, as well as a very short introduction to the video series. (This material is available on the 
pnmedical.com website.) 
 
All pre-recorded video material will be available on a single landing site throughout the study. The url will be shared with 
the participants at the kickoff educational meeting. Participants will be encouraged to revisit the video material to refresh 
content and technique. 
 
Intervention Phase (weeks 2-4):  
To create an individualized approach for each subject an integrative program developed to provide validated, non-invasive 
& integrative solutions. Integrative programs may include: 
• 
Respiratory Muscle Training (RMT) using Breather Fit device 
• 
Sleep & Intervention(s) 
• 
Stressor Inoculations (Situational Breathing Strategies, SBS)  
 
Subjects will begin their interactive program and that will be based on a participant’s weekly scorecard with an emphasis 
on functional improvements and positive reinforcement. The weekly scorecard will be sent as an email to the participant’s 
study email address as well as the PI for review.  Subjects will be asked to check this email weekly.  Subjects will 
continue to wear their Oura Ring device during their rest and sleep times. 
 
Participants will also be asked to begin the respiratory resilience program to activate and build-up their pulmonary system, 
and document their use of the Breather Fit device in a diary daily. 
 
Respiratory Resiliency Program is the optimization and strengthening of the respiratory muscle system for better 
pulmonary hygiene and improved cardiopulmonary function. Short effective respiratory high intensity training 

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
Page 8 of 9 
interventions provide rapid increase in respiratory and core muscle efficacy. Integration of high intensity training sessions 
with the biometric monitoring platform is provided to optimize compliance and adherence. 
 
End of Study (end of week 4):   
Study participants will again be requested to complete the cardiorespiratory fitness test assessment by walking for 6-12 
minutes.  The participant may choose to complete this test on a treadmill or using a pedometer, and they will need to self-
report the distance or steps and time walked for this test. 
 
Patients will be asked to return to the clinic for an in-person visit if possible (telephone and online will be an alternative).  
At this visit, subjects will be asked to complete end of study surveys, and return their completed Breather Fit device diary.  
Subjects will be able to keep the study intervention tools for continued personal use. 
 
Subject Information 
Target accrual: 10 Mayo Clinic frontline healthcare professionals 
 
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 
 
Review of medical records, images, specimens  
☒  The study involves data that exist at the time of IRB submission and data that will be generated after IRB submission. 
Include this activity in the Methods section.  
Examples 
• 
The study plans to conduct a retrospective chart review and ask subjects to complete a questionnaire.  
• 
The study plans to include subjects previously diagnosed with a specific disease and add newly diagnosed 
subjects in the future.  
• 
 
 
Data Analysis 
Power Statement:  The sample size for this pilot investigation (N=10) was established after considering both the 
statistical implications and the amount of project effort and resources required to recruit and study this unique patient 
population. 
Data Analysis Plan: Data related to subject recruitment will be summarized, including the frequency of calls and the 
reasons for failing screening criteria.  In all cases, data will be summarized using mean ± SD for continuous variables and 
frequency percentages for nominal variables. Treatment adherence will be quantified for each individual by calculating 
the percentage of sessions attended. The percentage of subjects who discontinue study participation and the reasons for 
discontinuing study participation will be summarized.   
 

Resilience Program Pilot  
PI: IT Croghan, PhD 
Mayo Clinic – NCT04536376 
 
 
 
 
 
 
 
 
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Patient demographics will be summarized using descriptive statistics.  Changes in resilience, stress and sleep will be 
calculated using a paired t test.  In all cases, two-tailed p-values ≤ 0.05 will be considered statistically significant. 
 
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