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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
260
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.
Stanford School of Medicine
Stanford, California, United States
Phase 1: Change in Walking on Earth Index (WONE) Index
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.
Time frame: Baseline, week 4, week 8
Phase 2: Change in WONE Index
WONE index is a 50-item validated measure of psychosocial resilience. Higher scores indicate greater resilience and well-being.
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
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