Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations (SIER-WONE)

Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations (SIER Study)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Well-being; Resilience, Psychological
• Intervention / Treatment: Behavioral: Intervention WONE App (full Version)

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chloe Yeung; Phone Number: 6502450094; Email: cayeung@stanford.edu
• Study Contact Backup: Name: Alan Yeung, MD; Phone Number: 6507282619; Email: ayeung@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Other: 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.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, week 4, week 8, week 12, week 16, week 20, week 24

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Walking on Earth Ltd.
• Investigators: Principal Investigator: Alan Yeung, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: resilience; mental well-being; stanford; entrepreneurs; WONE
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: 84749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study and early phase study. The plan for sharing individual participant data has not yet been determined. Study team will update after study has completed its enrollment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No