Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention WONE App (full Version).
- Who it may be relevant to
- Registry conditions: Resilience, Psychological, Mental Well-being. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations (SIER Study)
Overview
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
- Behavioral Intervention 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.
Primary outcome measures
- Phase 1: Change in Walking on Earth Index (WONE) Index [Time frame: Baseline, week 4, week 8]
- Phase 2: Change in WONE Index [Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Stanford School of Medicine — Stanford
Identifiers
NCT: NCT07565571 · 84749