Mental Well-being, Resilience, Psychological
Conditions
Keywords
resilience, entrepreneurs, mental well-being, stanford, WONE
Brief summary
High-achieving academic and entrepreneurial populations face elevated risks of chronic stress, anxiety, and burnout. These populations often underutilize mental health services due to stigma, time constraints, or accessibility issues. Digital interventions provide an opportunity to deliver evidence-based stress and resilience support at scale. The WONE (Walking on Earth, Ltd.) platform integrates personalized stress-resilience assessments, behavioral science micro-interventions, and optional wearable data feedback. This project aims to evaluate the feasibility, engagement, and preliminary efficacy of the WONE digital intervention in multiple Stanford-affiliated cohorts.
Detailed description
Primary Objective To evaluate whether engagement with the WONE app improves resilience, emotional well-being, and stress management outcomes among Stanford-affiliated adults. Secondary Objective To evaluate the feasibility of wearable-device integration. Rationale for Two-Phase Structure This protocol includes two sequential studies. 1. Phase 1 (Pilot): A single-arm feasibility pilot designed to assess acceptability of the WONE digital intervention, verify that onboarding, survey workflows, and data capture function smoothly, and identify any usability issues before running a randomized trial. 2. Phase 2 (Randomized Crossover RCT): A fully powered evaluation of the efficacy of WONE, using a 12-week crossover design to compare intervention vs. control periods, followed by a 6-month follow-up to evaluate maintenance of effects. Phase 1 Objectives (Pilot) 1. Assess feasibility and acceptability of the WONE digital intervention over 8 weeks. 2. Evaluate preliminary changes in resilience, emotional well-being, and stress management from baseline to Week 8. Secondary analysis will also explore changes in symptoms related to anxiety and depression. 3. Describe engagement patterns and examine whether engagement relates to changes in outcomes. 4. Assess feasibility of wearable integration, including connection rates and data completeness. Phase 2 Objectives (Randomized Crossover RCT) 1. Test the efficacy of the WONE intervention compared to a control period using a 12-week crossover design. 2. Examine changes in resilience, emotional well-being, and stress management across intervention vs. control phases. Secondary analysis will also explore changes in symptoms related to anxiety and depression. 3. Investigate engagement as a predictor of improvement. 4. Evaluate maintenance of effects at the 6-month follow-up.
Interventions
BEHAVIORALIntervention WONE App (full Version)
The Intervention WONE app (Full version) has the following features: * AI coaching for personalized support * Educational articles * Live sessions * On-demand session recordings * WONE Index assessment and tracking * Wearable device connection (optional) and wearable-derived scores and metrics The control WONE app (limited version) has no above features, only has push notifications for participants to complete assessments.
Sponsors
Stanford University
Walking on Earth Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Phase 1: Pilot (Single -Arm Pre-Post)- 8 weeks After app download, participants are asked to complete the WONE assessments and use the app\>3x/week and complete week 4 and 8 endpoints assessments. Phase 2: Randomized Crossover RCT- 24 weeks +6 months follow-up. Two-arm crossover design in which all participants experience both a control period (12 weeks) and an intervention period (12 weeks). The order is determined by random assignment. 1. Arm A: Control (Weeks 1-12) → Intervention (Weeks 13-24) 2. Arm B: Intervention (Weeks 1-12) → Control (Weeks 13-24) Following randomization and app download, participants complete the WONE assessments within the app and begin their assigned condition. Participants are asked to use the app\>3x/week and complete assessment every 4 weeks. At 12 weeks, app automatically switched. At 6 months, there will be a post-study follow-up to evaluate the maintenance of effects.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged between 18 and 65 years with Stanford affiliation 2. English proficiency with the ability to read, write, and complete surveys in English 3. Smartphone with internet access 4. Willingness to complete surveys and app activities 5. Resides in the US 6. Stanford affiliation 7. Wearable device for Phase 1 Pilot Study
Exclusion criteria
1. Severe psychiatric instability, defined as any of the following self-reported on the pre-enrollment screener: 1. Psychiatric hospitalization for a mental health crisis in the past 12 months. 2. Current mental health symptoms that significantly impair ability to function in daily life (e.g., unable to work, attend school, or care for basic needs). 2. No smartphone or unwilling to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Change in Walking on Earth Index (WONE) Index | Baseline, week 4, week 8 | WONE index is a 50-item validated measure of psychosocial resilience, recently validated against the Connor-Davidson Resilience Scale and the Brief Resilience Scale. Higher scores indicate greater resilience and well-being. |
| Phase 2: Change in WONE Index | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 | WONE index is a 50-item validated measure of psychosocial resilience. Higher scores indicate greater resilience and well-being. |
Countries
United States
Contacts
CONTACTChloe Yeung
CONTACTAlan Yeung, MD
PRINCIPAL_INVESTIGATORAlan Yeung, MD
Stanford University
Outcome results
None listed