An interventional study of Arena Strive and Control Cohort in Mental Health Disorder, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
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 for 12 weeks but will have optional access to the device for a total of 24 weeks.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 43 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks).
Device: Arena Strive
Participants randomized into the control cohort - survey at baseline and end of the study
Other: Control Cohort
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. The experimental intervention employed in this study will be a 12-week, multi-phased approach involving an asynchronous learning and coaching experience (6 weeks), and exploration phase (6 weeks).
Participants randomized into the control cohort - survey at baseline and end of the study
Change in Heart Rate Variability
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. Values represent heart rate at specific intervals. The higher the HRV generally the better
Time frame: Week 16
Change in Resting Heart Rate
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. The lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.
Time frame: Week 16
Change in Time Spent in Bed
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Time frame: Week 16
Change in Sleep Quality
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Time frame: Week 16
Change in Sleep Consistency
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Time frame: Week 16
Change in Sleep Debt
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
Time frame: Week 16
Change in Amount of Burn Out (MBI) Malasch Burnout Inventory
Each item is measured on a scale of 0 to 6 and Total scores range from 0 (less/better burnout) - to 42 (more/worse burnout) - Total score of 17 or less: low level burnout total between 18 and 29 inclusive: moderate burnout total over 30: high-level of burnout
Time frame: Week 16
Change in Self-reported Professional Fulfillment (PFI)
collected by means of a survey link at key benchmark moments throughout the intervention period - Each item within PFI scored from 0 to 4 with higher scores being more favorable - scores range from 0 - 24 with higher scores denoting higher fulfillment
Time frame: Week 16
Change in Self-valuation Scores (Stanford Self-Vaulation)
collected by means of an in-app survey at key benchmark moments throughout the intervention period - Each item in the self-valuation scale included 4 items measured on a 5-point (0-4) Likert scale lower scores meaning more positivity -scores range from 0 - 16 with lower score denoting more positivity
Time frame: Week 16
Change in Personal Achievement (MBI)
"Each Item Measured on a scale of 0 to 6; Total 33 or less: high-level burnout - Total between 34 and 39 inclusive: moderate burnout - Total greater than 40: low-level burnout" Scores range from 0 - 48 with higher scores denoting less burnout
Time frame: week 16
Change in Depersonalization (MBI)
"Each item measured on a scale of 0 to 6; total score of 5 or less: low level burnout - total between 6 and 11 inclusive: moderate burnout - total over 12 and greater: high-level of burnout" - scores ranging from 0 - 42 with higher scores denoting more burnout
Time frame: week 16
Change in Burnout Scores (PFI) - Professional Fulfillment Index
Scores ranging 0 - 40 with higher scores denoting more exhaustion Likert scale ranging from "not at all" to "extremely" for work exhaustion and interpersonal disengagement item" - lower scores meaning less exhaustion
Time frame: week 16
Change in Self-reported Satisfaction of the Arena Strive Platform
collected by means of an in-app survey at key benchmark moments throughout the intervention period - client satisfaction questionnaire 8 (CSQ-8) - Scores therefore range from 8 to 32, with higher values indicating higher satisfaction.
Time frame: Week 12
Recommendation Score of the Arena Strive Platform
Net Promoter Score with the question of likelihood to recommend - Net Promoter Score (NPS) is calculated by (promoters-detractors)/total respondents. The range is -100 to 100. The closer you are to 100 the more likely recommend.
Time frame: Week 12
| Milestone | Arena Strive | Control Cohort |
|---|---|---|
| Started | 29 | 14 |
| Completed | 20 | 14 |
| Not completed | 9 | 0 |
| Withdrew: Non responders | 9 | 0 |
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. Values represent heart rate at specific intervals. The higher the HRV generally the better
| Milliseconds | Arena Strive |
|---|---|
| Beginning (Week 6) | 39 (27 to 56) |
| Mid (Week 12) | 47 (32 to 65) |
| End (Week 16) | 54 (35 to 82) |
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback. The lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.
| Beats per Minute | Arena Strive |
|---|---|
| Beginning (Week 6) | 63 (57 to 68) |
| Mid (Week 12) | 60 (55 to 65) |
| End (Week 16) | 57 (51 to 61) |
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
| hours | Arena Strive |
|---|---|
| Beginning (Week 6) | 7.69 (6.83 to 8.67) |
| Mid (Week 12) | 7.60 (6.60 to 8.55) |
| End (Week 16) | 7.59 (6.56 to 9.05) |
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
No measurements were reported for this outcome.
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
No measurements were reported for this outcome.
measured by the WHOOP biometric device - The WHOOP wearable brings hi-tech features including sleep, workout, heart rate feedback and more advanced biometrics in a simple package - the latest, most advanced fitness and health wearable available. Monitor your recovery, sleep, training, and health, with personalized recommendations and coaching feedback.
No measurements were reported for this outcome.
Each item is measured on a scale of 0 to 6 and Total scores range from 0 (less/better burnout) - to 42 (more/worse burnout) - Total score of 17 or less: low level burnout total between 18 and 29 inclusive: moderate burnout total over 30: high-level of burnout
| score on a scale | Arena Strive | Control Cohort |
|---|---|---|
| Week 6 | 20 ± 9 | 22 ± 9 |
| Week 12 | 17 ± 8 | 15 ± 10 |
| Week 16 | 16 ± 10 | 32 ± 6 |
collected by means of a survey link at key benchmark moments throughout the intervention period - Each item within PFI scored from 0 to 4 with higher scores being more favorable - scores range from 0 - 24 with higher scores denoting higher fulfillment
| score on a scale | Arena Strive | Control Cohort |
|---|---|---|
| Week 6 | 2.30 ± 0.75 | 2.50 ± 0.73 |
| Week 12 | 2.58 ± 0.67 | 2.14 ± 0.73 |
| Week 16 | 2.69 ± 0.99 | 2.07 ± 0.74 |
collected by means of an in-app survey at key benchmark moments throughout the intervention period - Each item in the self-valuation scale included 4 items measured on a 5-point (0-4) Likert scale lower scores meaning more positivity -scores range from 0 - 16 with lower score denoting more positivity
| score on a scale | Arena Strive | Control Cohort |
|---|---|---|
| Week 6 | 5.93 ± 2.42 | 6.57 ± 2.59 |
| Week 12 | 7.19 ± 2.84 | 6.85 ± 2.70 |
| Week 16 | 7.60 ± 2.68 | 7.64 ± 2.87 |
"Each Item Measured on a scale of 0 to 6; Total 33 or less: high-level burnout - Total between 34 and 39 inclusive: moderate burnout - Total greater than 40: low-level burnout" Scores range from 0 - 48 with higher scores denoting less burnout
| score on a scale | Arena Strive | Control Cohort |
|---|---|---|
| Week 6 | 38 ± 8 | 35 ± 7 |
| Week 12 | 37 ± 9 | 34 ± 7 |
| Week 16 | 37 ± 9 | 32 ± 6 |
"Each item measured on a scale of 0 to 6; total score of 5 or less: low level burnout - total between 6 and 11 inclusive: moderate burnout - total over 12 and greater: high-level of burnout" - scores ranging from 0 - 42 with higher scores denoting more burnout
| score on a scale | Arena Strive | Control Cohort |
|---|---|---|
| Week 6 | 15 ± 8 | 12 ± 8 |
| week 12 | 11 ± 7 | 14 ± 9 |
| Week 16 | 11 ± 8 | 15 ± 10 |
Scores ranging 0 - 40 with higher scores denoting more exhaustion Likert scale ranging from "not at all" to "extremely" for work exhaustion and interpersonal disengagement item" - lower scores meaning less exhaustion
| score on a scale | Arena Strive | Control Cohort |
|---|---|---|
| Week 6 | 1.54 ± 0.67 | 1.56 ± 0.55 |
| Week 12 | 1.23 ± 0.63 | 1.76 ± 0.63 |
| Week 16 | 1.20 ± 0.84 | 1.76 ± 0.70 |
collected by means of an in-app survey at key benchmark moments throughout the intervention period - client satisfaction questionnaire 8 (CSQ-8) - Scores therefore range from 8 to 32, with higher values indicating higher satisfaction.
| score on a scale | Arena Strive |
|---|---|
| Change in Self-reported Satisfaction of the Arena Strive Platform | 25.77 ± 5.45 |
Net Promoter Score with the question of likelihood to recommend - Net Promoter Score (NPS) is calculated by (promoters-detractors)/total respondents. The range is -100 to 100. The closer you are to 100 the more likely recommend.
| score on a scale | Arena Strive |
|---|---|
| Recommendation Score of the Arena Strive Platform | 7.45 ± 2.61 |
Collected over through study completion, an average of 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arena Strive | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Control Cohort | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
Patients were randomized into either control or intervention group (Arena Strive)
| Age, Categorical(Participants) | Arena Strive | Control Cohort | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 14 | 43 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Arena Strive | Control Cohort | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Arena Strive | Control Cohort | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices)
Supporting information: Study protocol
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences