Atrium Health - Arena Labs Research Protocol
Phase: NA
Conditions: Mental Health Disorder
Sponsor: Wake Forest University Health Sciences

Last Updated: 2.24.2023  
 
                     
 
 
ARENA LABS - IMPROVING CLINICIAN WELL BEING 
 
IRB00090882 
 
NCT05653700 
IRB Approval Date:  03.01.2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Last Updated: 2.24.2023  
 
                     
 
Atrium Health | Arena Labs Research Protocol 
 
Project Title 
The effect of an asynchronous coaching platform on measures of physiological resilience, professional 
fulfillment, burnout, self-valuation, and overall satisfaction in Atrium Health Sanger Heart and Vascular 
Institute Surgery, Emergency Department, and Pulmonary Critical Care Physicians and Advanced 
Practice Providers. 
 
Principal Investigator and Co-Investigator Information 
Principle Investigator: Dr. Kevin Lobdell 
 
Research Question/Hypothesis 
What is the effect of educational content; data feedback and monitoring; and tailored coaching 
touchpoints provided through an asynchronous coaching platform on measures of physiological 
resilience, professional fulfillment, burnout, self-valuation, and overall satisfaction in full time clinical 
providers? 
 
Objectives 
The primary objective of this study will be to determine the efficacy of the asynchronous performance 
coaching platform, Arena Strive at changing measures of physiological resilience, professional 
fulfillment, burnout, and self-valuation in full time clinicians. The anticipated primary outcome will be 
an improvement in measures related to clinician resilience including self-reported professional 
fulfillment and self-valuation; factors measured by the WHOOP biometric device: Heart rate variability 
(HRV), resting heart rate (RHR), time spent in bed, sleep quality, sleep consistency, reduction in “sleep 
debt”; and a reduction in burnout. Expected secondary outcomes include an overall high level of self-
reported acceptance, satisfaction, and feasibility of the Arena Strive Platform. 
 
● 
Primary outcome: Increases in physiological and self-reported measures of resilience / 
decreases in burnout measures. 
● 
Secondary outcome: Feasibility, acceptance, satisfaction of Arena Strive platform 
 
Background to Research Questions 
Recent literature has found that burnout is highly prevalent among healthcare professionals, affecting 
between 40-60% of physicians. [1] The added stressors of the COVID-19 pandemic have also been 
associated with high rates of multidisciplinary healthcare professional burnout, depression and anxiety, 
especially among women, nurses, and those working in hospital environments.[2-3] Mental health 
disorders are also prevalent among health care workers. In a study of 4833 physicians, 41.7% screened 
positive for depressive symptoms and 6.9% reported having suicidal ideation in the previous year, of 
whom 27% reported that they would probably or definitely not seek help.[4] The healthcare 
professionals most in need of care and burnout prevention modalities are those least likely to seek 
support, with a perceived stigma associated with seeking help.[5] These findings contribute to the 
mounting body of evidence suggesting there is a significant unmet gap in this vulnerable population. 
 
Healthcare clinicians work in a high-stress environment that requires quick decision making and high 
levels of both mental and physical acuity. Like other performance careers, a clinician’s own mental and 
physical states are key to their ability to take optimal care of their patients. However, despite the 

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similarities shared with these other performance careers, performance coaching, well-being 
interventions, and other burnout prevention initiatives are commonly perceived as either ineffective, or 
out of reach to the health professional workforce due to time restraints, lack of knowledge, or pre-
existing stigmas around help seeking. Arena Strive and WHOOP aim to address these barriers by 
democratizing performance coaching with a seamless asynchronous coaching experience at the 
clinicians fingertips. 
METHODOLOGY 
Study design 
This study is a prospective randomized controlled longitudinal crossover design with a per protocol 
analysis integrating one sensor (WHOOP, inc Platform) and one educational intervention (Arena Strive 
Platform). The WHOOP sensor collects data on heart rate (HR), heart rate variability (HRV), and sleep 
data, and will be worn by all participants in the experimental intervention. Participants will be asked to 
wear the biometric sensor for12 weeks but will have optional access to the device for a total of 24 weeks.  
 
Throughout the 12 week intervention period, participant engagement within the Arena Strive app will 
be collected including data points relating to videos/audio watched or listened to, content favorited, or 
user activities completed. Modifiable activities collected via the Arena Strive Platform include light 
exposure, light restriction, sleep hygiene, meal timing, and activation and deactivation techniques 
(yoga nidra, physiological sigh, super O2 breathing).  
 
Self-reported data will also be collected relating to the participants ability to adapt to stress, rest and 
recover from stress, and self-awareness around these two constructs. WHOOP data, engagement 
within the Arena Strive app, and self-reported stress adaptability, rest and recovery, and self-awareness 
will be collected continually throughout the intervention period. The additional self-reported outcomes: 
professional fulfillment, burnout, self-valuation, and overall satisfaction will be collected by means of an 
in-app survey at key benchmark moments throughout the intervention period: once at intervention 
start, again at week 6 following the first phase of the Arena Strive intervention, then again at week 12 
following the completion of the experimental intervention period. Participants in the control cohort will 
follow this same time frame with respect to self-reported surveys. All self-reported data within the 
control cohort will be collected via identical surveys hosted on Typeform, the web-based surveying 
platform. 
 
The experimental intervention, 'Arena Strive', will be conducted through the Arena Strive app, self-
described as "Healthcare’s First Performance Coach”. This second-generation platform provides 
frontline clinicians with a comprehensive journey to access the tools, training, and technology used by 
other high-pressure fields to increase performance and enhance resilience. Strive uses a dynamic, 
interactive content platform to bring frontline clinicians the lessons learned, tools, and tailored 
instruction of world-class performers from elite military, professional athletes, and creative performers. 
The design will test the effect on measures of professional fulfillment and burnout; self-valuation; 
satisfaction; and feasibility in full-time NHS clinicians. 
 
Intervention   
The experimental intervention employed in this study will be a 12-week, multi-phased approach 
involving asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks). 
 

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Phase 1: Enrollment period and participant recruitment, obtain informed consent, complete WHOOP 
device setup & download Arena Strive app.  During the study kickoff, intervention participants can 
choose to attend coaching workshops with an Arena labs performance coach to learn more about the 
principles of high-performance medicine, biometric data, and the Arena Strive platform. 
 
Phase 2: In the second phase, a performance coaching platform comprising educational content; data 
feedback and monitoring; and tailored coaching touchpoints will then be administered via the 
smartphone application, Arena Strive for a duration of 6 weeks (Arena Strive :: Foundations).Arena Labs 
performance coaches can be accessed via the app. Arena Labs performance coaches provide 
personalized coaching tailored to the individual clinician and his/ her unique set of needs. The 
intervention will also include a wearable biometric device provided by WHOOP to collect physiological 
data relating to measures of resilience and autonomic function. The accompanying WHOOP app will be 
available  in this phase of the intervention. Data from the wearable device will be passed directly into 
the Arena Strive app to be summarized and delivered to participants through the app interface for self-
monitoring, feedback, and coaching touchpoints.  
 
Phase 3: After 6 weeks of asynchronous guidance through the Arena Strive app, users will then 
continue the intervention (Arena Strive :: Explorations) with an additional 6 week experience of data 
feedback.  
 
As a behavioral intervention, Arena Strive follows the COM-B framework of behavior change, which 
targets participants’ capabilities (C), opportunities (O), and motivations (M) to integrate performance 
practices into their routines. The first phase of the intervention will involve 6 weeks of micro-learning 
audio and video content targeting clinicians’ capabilities and opportunities to learn and train 17 
foundational performance practices. Targeted behavior change techniques (BCTs) help participants 
overcome barriers, monitor progress, and build intrinsic motivation toward the integration of these 17 
practices. These practices leverage techniques and physiological processes that aim to influence the 
three main foundations of High Performance Medicine: self-awareness, rest & recovery, and stress 
adaptability. Techniques include but are not limited to autonomic regulation, self-reflection, 
environmental restructuring, task-based coping, emotion-based coping, guided attention control, and 
shaping behavior around physiological triggers. 
 
Control Cohort: Participants randomized into the control cohort will receive no intervention for the 
duration of the experimental intervention. At the conclusion of the full 12  week baseline and 
intervention period, participants in the control cohort will be given the option to participate in the 
intervention. 
 
Setting  
The study will take place within the Atrium Health Sanger Heart and Vascular Institute, Emergency 
Department, Surgery  and Pulmonary Critical Care.. All data collection, intervention, and participant 
interaction will take place asynchronously through the Arena Strive smartphone application, and the 
WHOOP wearable biometric device. 
 
Expected Start Date 
The expected enrollment will begin on January 2023 for both cohorts.  
 

Last Updated: 2.24.2023  
 
                     
 
Duration of Study 
The total length of this study will be 24 weeks from participant recruitment to conclusion of data 
analysis. 
 
● 
6 weeks = Phase 1   Enrollment period and participant recruitment, obtain informed consent, 
complete WHOOP device setup & download Arena Strive app. 
● 
6 weeks = Phase 2: Arena Strive Intervention period (Arena Strive :: Foundations) 
● 
6 weeks = Phase 3 Continue WHOOP device & Arena Strive Intervention (Arena Strive :: 
Explorations) 
● 
6 weeks = Data analysis 
 
Study Participants 
Participants sought for this study will include full time Physicians and Advanced Practice Providers  
employed by Atrium Health Sanger Heart and Vascular Institute, Surgery, Emergency Department, and 
Pulmonary Critical Care. Investigating this special subject population will allow the study team to 
address with the greatest accuracy the effects of the proposed intervention on the unique workforce at 
Atrium Health. The maximum number of subjects sought for this study is 100; with a 2:1 randomization 
ratio with 2/3 receiving the experimental intervention, and 1/3 receiving no intervention to act as an 
inactive control. 
 
Note: The employees who volunteer for participation but are assigned to the control condition will be 
given the opportunity to participate in the exact same program at the completion of the trial with the 
experimental group. Those employees who take this opportunity can then serve as an internal 
replication of the findings with the experimental group. 
 
All Participants must meet the following Inclusion/ Exclusion Criteria. Criteria points will be self-
reported and acknowledged by the participant. 
 
Key Inclusion Criteria:  
● 
Employed full time by an Atrium Health affiliated entity 
● 
Age 18+ 
● 
Willing and able to give written informed consent for study participation. 
● 
Healthcare workers working ≥ 36 hours of clinical duties/week. 
● 
Willingness to wear WHOOP and keep it charged for the entire duration of study. 
● 
Have a smart phone for pairing with WHOOP and the Arena Strive platform. 
 
Key Exclusion Criteria:  
● 
Current diagnosis of a sleep-related breathing disorder including obstructive sleep apnea not 
being treated (with or without continuous positive airway pressure (CPAP) treatment) 
● 
Circadian rhythm sleep-wake disorders 
● 
Narcolepsy 
● 
Recurrent isolated sleep paralysis 
● 
Restless legs syndrome 
● 
Periodic Leg Movement Disorder 
● 
Comorbid nocturia or other conditions (eg. benign prostatic hyperplasia) resulting in frequent 
need to get out of bed to use the bathroom during the night (≥3 times per night average) 
● 
Atrial Fibrillation 
● 
COPD other than mild, pulmonary fibrosis or severe chronic lung disease 
● 
Sleep apnea or undergoing treatment for a sleep related illness 

Last Updated: 2.24.2023  
 
                     
 
● 
Lack of availability of iPhone or Android device 
● 
Part-time clinical duties 
 
Participant Consent: All participants involved in this study will be required to provide written consent to 
participate. Participants will be asked to consent to the collection of self-reported data provided 
through in-app and digital surveys as well as biometric data collected through the WHOOP device. A 
copy of the written consent form is included in the appendix. Spanish language consents will be made 
available upon request. 
 
Equipment/Supplies/Services 
All equipment, services, and supplies related to the study intervention will be provided by Arena Labs, 
and WHOOP. All equipment, services, and supplies related to the recruitment of study participants will 
be provided by the Atrium Health team. 
 
Data Collection 
All study data will be collected via an in-app or online survey, through app interactions, or through the 
WHOOP wearable biometric device. Data collection for the control cohort will mirror that of the 
experimental group in both frequency and content with a select few exceptions. Control cohort 
participants will not receive questions relating to feasibility and satisfaction, and self-reported data will 
be collected via online surveys hosted on Typeform. A breakdown of the primary and secondary 
outcome variables are summarized below. 
 
 
 
Outcome Variable 
Instrument 
Collection Method 
Primary 
Outcomes 
Self 
Reported 
Professional Fulfillment & 
Burnout 
Stanford 
Professional 
Fulfillment Index 
(PFI) 
Onboard, 
midpoint, and exit 
Survey 
“Gold standard” for measuring 
burnout 
Maslach Burnout 
Inventory (MBI) 
Onboard, 
midpoint, and exit 
Survey 
 
Self Valuation 
 
Stanford Self 
Valuation Scale 
 
Onboard, 
midpoint, and exit 
Survey 
Biometric 
Data 
HRV 
WHOOP Strap 
Continuous 
SWS % 
WHOOP Strap 
Continuous 
REM % 
WHOOP Strap 
Continuous 
RHR 
WHOOP Strap 
Continuous 
Awake Time 
WHOOP Strap 
Continuous 
Light Sleep Duration (%) 
WHOOP Strap 
Continuous 

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Sleep Disturbances 
WHOOP Strap 
Continuous 
Sleep Debt 
WHOOP Strap 
Continuous 
Sleep Consistency 
WHOOP Strap 
Continuous 
Secondary 
Outcomes 
Self-
reported 
Satisfaction 
Client Satisfaction 
Questionnaire-8 
(CSQ-8) 
Exit Survey 
Feasibility/Adherence  
NA 
In-app Survey & 
app engagement 
 
Data Analysis 
● 
We will use t-tests in SPSS to compare the primary outcome measures across the experimental 
and control groups. 
● 
We will also test for dose effects in the experimental condition via a series of correlational 
analyses that estimate whether the extent of engagement with the Arena Strive platform 
predicts better outcomes on the primary measures. 
● 
We will use multilevel-modeling (MLM) in R (using the lme4 package) to compare the various 
indicators of sleep duration and quality, as well as HRV and RHR, across time as a function of 
participation in the experimental vs. control conditions. We will allow random intercepts and 
slopes to model the possibility that some individuals will show different baselines and/or larger 
effects of participation in the experimental condition than others.  
● 
We will also test for dose effects in the experimental condition via a series of MLMs that 
estimate whether extent of engagement with the Arena Strive platform predicts better sleep 
performance and recovery. 
● 
Finally, we will estimate a series of regression-based mediational models that test whether the 
Arena Strive manipulation enhances sleep and recovery, which in turn enhance the primary 
outcome measures. 
Data Management  
WHOOP maintains a Member Data Retention & Disposal Policy to govern our data management 
practices.  
 
All WHOOP member data retained in any WHOOP environment is subject to the WHOOP's access 
control, information classification, and key management and cryptography policies. When a data 
subject requests access to their WHOOP member data, WHOOP takes measures to validate the 
identity of the requestor to ensure the security of the data being provided. 
 
Disposal of WHOOP member data will be carried out in accordance with the contractual agreement 
between WHOOP and the member. In the absence of any contractual agreement with respect to 
Personal Data disposal, an automatic script or manual script (for ad-hoc requests) may be requested by 
a data subject and, after verifying the identity of the requestor, shall be initiated on the WHOOP 

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platform containing WHOOP member data. This activates a deletion of WHOOP member data on the 
platform, except for those data elements required to satisfy legal and financial retention requirements. 
 
In connection with our research partnerships, WHOOP will only provide member data to our partners in 
an anonymized, de-identified manner. 
 
Within the Arena Strive platform, individual-level data is only shared with the individual. Deidentified, 
aggregate data is shared with leaders with informed consent of participants. All data collected through 
Arena Strive including self-reported data and in-app engagement data is owned and stored by Arena 
Labs Inc. in line with the company’s privacy principles below. Arena-Strive technology is HIPAA 
compliant. Per written privacy policy, Arena Strive does not sell any data and maintains the highest 
level of privacy standards for all data collected. In line with the Arena Strive data privacy policy, and in 
partnership with WHOOP, every volunteer participant user has the right to control their own data. Any 
user can choose to have their individual information deleted at any point.  
 
Arena Labs Data Privacy Policy 
 
● 
Compliance - Strive solution is deployed on AWS cloud services which are HIPAA, PCI-DSS, PA-
DSScertified. We store no user PHI. The Strive solution is accessible to registered and verified 
users only. Their data is stored in AWS data sources housed in Amazon’s US-East location data 
servers. The organization's IT infrastructure is deployed on AWS and accessed securely by the 
employees. 
● 
Personal Device Use Only - Strive Platform does not need any computing equipment hosted in 
the organization's premises. The organization’s network would not be accessed by any 
user/third party. Strive is a web based platform and does not require any on-premises 
deployment or network access. 
● 
Security Framework - Arena Labs infrastructure and Strive platform is developed and deployed 
based on the security controls of NIST SP800-53 R4, HIPAA and HITRUST CSF. The underlying 
cloud technologies are NIST/HITRUST/ISO 27001/CIS certified. 
● 
Data Storage - Strive anonymizes and encrypts PII data stored in durable AWS data sources--
including usernames, emails, cell-phone numbers, dates of birth, stress levels, heart rates, & 
respiratory metrics--to ensure it is secured against unauthorized access or use. 
 
Identified Risks/Ethical Considerations 
De-identified data from the applications (WHOOP, Arena-Strive) will be shared with the study 
coordinator and collaborators listed in the application. No identifiers will be shared with any third party 
persons or services. Should any participant find wearing any device uncomfortable they will be able to 
not participate in that part of the study. The other aspects of the study (i.e. Arena Strive educational 
content) will still be available for their use. Hospital employees are potentially vulnerable subjects and 
will be protected in two ways. First, all specific identifying information will be coded and assigned study 
number and device serial number. The data that are collected for analysis by the investigators will not 
necessitate access to any identifiable medical records. The study investigators will be the sole 
individuals with access to the identity of the specific assigned study numbers. Secondly, the 
recruitment material and informed consent will clarify that the decision to participate is voluntary and 
performance during the study is in no way tied to their employment or pay. 
 

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Individual results will not be shared with any hospital leadership or administration, or with the 
participant’s coworkers or supervisors unless those members are among the study investigators and 
with the explicit informed consent from the participant. Participants have access to their own personal 
physiological data via the Arena Strive and WHOOP apps and individual logins to the WHOOP website. 
Language will be included in the consent document to reflect the importance of provider well-being. 
Incidental findings may be identified throughout the study, such as identifying stressors that 
contribute to anxiety or depression. These will be handled appropriately, with recommendations and 
resources for professional help. At any point, the participant may choose not to answer a survey 
question for any reason. 
 
Benefits of Proposed Research to the Subjects and Others (significance of your study) 
Study participants will have real-time access to their personal biometric data which can be used to 
assess their own physiologic response throughout daily work, exercise and sleep. In prior studies 
conducted by WHOOP, after 4 months on the WHOOP platform, tactical athletes, medical 
professionals, and professional athletes on average improved time spent in deep sleep with improved 
sleep performance and reduced alcohol consumption within 2 hours of bedtime, as well as reduced 
pre-bedtime screen-time. These improved behaviors translated to statistically significant physiological 
advantages seen by increased heart rate variability and reduced resting heart rate. Participants across 
these cohorts also showed a positive downward trend in reported stress and sickness. Participants in 
both groups will have access to the Arena Strive targeted education platform where they will be 
shepherded through various techniques and tools to help manage and buffer stress. 
 
The Arena Strive platform was built to bring a data-driven, scalable and cost-effective solution to the 
challenge of burnout in healthcare. Prior studies conducted have shown that after 4 months of real-
time data access provided by the Whoop device, tactical athletes, medical professionals, and 
professional athletes on average improved time spent in deep sleep with improved sleep performance 
and reduced alcohol consumption within 2 hours of bedtime, as well as reduced pre-bedtime screen-
time. These improved behaviors translated to statistically significant physiological advantages seen by 
increased heart rate variability (HRV) and reduced resting heart rate. Participants across these cohorts 
also showed a positive downward trend in reported stress and sickness. These results are mirrored in 
early adopters of the Arena Strive platform with increases in sleep efficiency and reductions in resting 
heart rate (RHR) across users of all engagement levels.  
 
Arena Strive’s targeted education platform provides an additional layer of context and benefit to 
subjects by shepherding users through various techniques and tools to help manage and buffer the 
metrics provided by the Whoop device. This additional layer of context in comparison to physiological 
data access alone has yielded greater increases in heart rate variability (HRV) and rapid eye movement 
sleep (REM) as shown in users who are highly engaged in the Arena Strive platform. Early benefits 
experienced by Arena Strive users extend beyond physiological markers of performance as well. Users 
of the Arena Strive platform have also reported a more than 12% increase in self-reported energy 
management, adaptability, and self-awareness. 
 
The Arena Strive experience prioritizes health professionals and provides them with the same tools, 
science, and frameworks used in other high-pressure fields; however, the benefits of this first-of-its-kind 
platform extend beyond the individual users. Anticipated benefits to the involved NHS institutions will 
mirror those already seen in contracted institutions engaging with Arena Strive. While traditional 
approaches to reduce burnout and promote resilience in healthcare workforces require extensive time, 
resources, and involvement from the responsible healthcare institution, Arena Strive steps in to take the 
burden off of the institution by delivering a fully packaged intervention. The components comprising 
the Arena Strive platform aim to deliver a revolutionary tool that radically transforms the way hospitals 

Last Updated: 2.24.2023  
 
                     
 
think about performance in the healthcare setting by providing an experience that is embedded, 
proactive, data driven, accessible, and acceptable. 
 
1. 
Embedded: While similar interventions demand the use of long blocks of discretionary time 
outside of work as well as hospital resources, the Arena Strive platform is designed to be 
embedded in the workday. In addition, while it is often the case that individuals access and 
learn resilience strategies in isolation, our team-based methodology leverages the wellbeing 
benefits of community-building and the benefits of social contagion in cementing behavior 
change. 
2. 
Proactive: Resilience tools and resources are often deployed after an individual or team is 
already suffering from burnout. Our program is designed to function as a preventative measure 
upstream of burnout by engaging individuals proactively, though it is also beneficial for those 
who are already experiencing burnout.  
3. 
Data-driven: The Arena Strive platform allows individuals and teams to assess their stress and 
burnout and evaluate the effectiveness of resilience techniques in real time. De-identified, 
summarized daily survey and physiologic data can inform organizational interventions and 
culture change to address drivers of stress and burnout. 
4. 
Accessible: The Arena Strive platform is asynchronous and available 24/7 to users regardless of 
shift, maximizing accessibility to the NHS employees and reducing the barriers associated with 
accessing traditional resilience training. 
5. 
Acceptable: Due to the stigma around help-seeking and mental health diagnoses and a 
professional culture that has traditionally associated self-care with weakness, healthcare 
professionals can be hesitant to engage with resilience modalities that are framed as “wellness” 
or “self-care.” Arena Strive is explicitly framed around the connection between resilience, 
endurance, and performance and is contextualized to appeal to healthcare professionals. 
 
Participant reimbursement/compensation 
Subjects will not receive money, incentives, payment, or reimbursement for participation in this study. 
Each participant will keep the Whoop device issued to them.   
 
References 
1. 
Shanafelt TD, et al. Changes in Burnout and Satisfaction with Work-Life Integration in 
Physicians and the General US Working Population Between 2011 and 2017. Mayo Clin Proc. 2019 
Sep;94(9):1681-1694. 
2. 
Gualano MR, et al. The Burden of Burnout among Healthcare Professionals of Intensive Care 
Units and Emergency Departments during the COVID-19 Pandemic: A Systematic Review. Int J 
Environ Res Public Health. 2021 Aug 2;18(15):8172. 
3. 
Prasad K, et al. Prevalence and correlates of stress and burnout among U.S. healthcare workers 
during the COVID-19 pandemic: A national cross-sectional survey study. EClinicalMedicine. 2021 
May 16;35:100879. 
4. 
Shanafelt TD, Dyrbye LN, West CP, Sinsky C, Tutty M, Carlasare LE, Wang H, Trockel M. Suicidal 
Ideation and Attitudes Regarding Help Seeking in US Physicians Relative to the US Working 
Population. Mayo Clin Proc. 2021 Aug;96(8):2067-2080. 
5. 
Brower KJ. Professional Stigma of Mental Health Issues: Physicians Are Both the Cause and 
Solution. Acad Med 2021;96(5):635–40. 

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ATTACHMENTS 
Survey (if using a survey) 
Data collection spreadsheet 
Consent forms if needed