Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations

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.

• 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.
• 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)

• Assess feasibility and acceptability of the WONE digital intervention over 8 weeks.
• 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.
• Describe engagement patterns and examine whether engagement relates to changes in outcomes.
• Assess feasibility of wearable integration, including connection rates and data completeness.

Phase 2 Objectives (Randomized Crossover RCT)

• Test the efficacy of the WONE intervention compared to a control period using a 12-week crossover design.
• 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.
• Investigate engagement as a predictor of improvement.
• Evaluate maintenance of effects at the 6-month follow-up.

Inclusion criteria

• Aged between 18 and 65 years with Stanford affiliation
• English proficiency with the ability to read, write, and complete surveys in English
• Smartphone with internet access
• Willingness to complete surveys and app activities
• Resides in the US
• Stanford affiliation
• Wearable device for Phase 1 Pilot Study

Exclusion criteria

• Severe psychiatric instability, defined as any of the following self-reported on the pre-enrollment screener:

• Psychiatric hospitalization for a mental health crisis in the past 12 months.
• 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).
• No smartphone or unwilling to consent.