Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations (SIER Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Stanford University
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Phase 1: Change in Walking on Earth Index (WONE) Index
Study Overview
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.
- 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Phase 2: Control (Weeks 1-12) then Intervention (Weeks 13-24)
Arm A: The control and intervention conditions are delivered via two separate versions of the WONE mobile application: 1. Control WONE app (limited version) - used during control periods 2. Intervention WONE app (full version) - used during intervention periods. At baseline, participants download the Control version. At Week 12, participants receive instructions via email to download the alternate Intervention version. The participants are blinded to the sequence.
Intervention: Intervention WONE App (full Version) (Behavioral)
Phase 2: Intervention (Weeks 1-12) then Control (Weeks 13-24)
Arm B: The control and intervention conditions are delivered via two separate versions of the WONE mobile application: 1. Intervention WONE app (full version) - used during intervention periods. 2. Control WONE app (limited version) - used during control periods. At baseline, participants download the Intervention version. At Week 12, participants receive instructions via email to download the alternate Control version. Participants are blinded to the sequence.
Intervention: Intervention WONE App (full Version) (Behavioral)
Phase 1 (pilot, single arm)
Participants will download the web application for 8 weeks and asked to complete the WONE assessments and use the app for more than 3 times per week and complete week 4 and 8 endpoints assessments.
Intervention: Intervention WONE App (full Version) (Behavioral)
Outcomes
Primary Outcomes
Phase 1: Change in Walking on Earth Index (WONE) Index
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Alan Ching Yuen Yeung
Professor in Medicine
Stanford University