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

NCT07565571 | Not Yet Recruiting

• 1 other identifier: 84749
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Resilience, Psychological; Mental Well-being

Keywords

resilience; entrepreneurs; mental well-being; stanford; WONE

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Phase 2: Control (Weeks 1-12) then Intervention (Weeks 13-24)

OTHER

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)

Phase 2: Intervention (Weeks 1-12) then Control (Weeks 13-24)

OTHER

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)

Phase 1 (pilot, single arm)

OTHER

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)

Interventions

Intervention WONE App (full Version) BEHAVIORAL

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.

Phase 1 (pilot, single arm); Phase 2: Control (Weeks 1-12) then Intervention (Weeks 13-24); Phase 2: Intervention (Weeks 1-12) then Control (Weeks 13-24)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walking on Earth Ltd.: collaborator
• Stanford University: lead

Study Sites (1)

Stanford School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Alan Yeung, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe Yeung

CONTACT

6502450094; cayeung@stanford.edu

Alan Yeung, MD

CONTACT

6507282619; ayeung@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Medicine

Model Details: Phase 1: Pilot (Single -Arm Pre-Post)- 8 weeks After app download, participants are asked to complete the WONE assessments and use the app\>3x/week and complete week 4 and 8 endpoints assessments. Phase 2: Randomized Crossover RCT- 24 weeks +6 months follow-up. Two-arm crossover design in which all participants experience both a control period (12 weeks) and an intervention period (12 weeks). The order is determined by random assignment. 1. Arm A: Control (Weeks 1-12) → Intervention (Weeks 13-24) 2. Arm B: Intervention (Weeks 1-12) → Control (Weeks 13-24) Following randomization and app download, participants complete the WONE assessments within the app and begin their assigned condition. Participants are asked to use the app\>3x/week and complete assessment every 4 weeks. At 12 weeks, app automatically switched. At 6 months, there will be a post-study follow-up to evaluate the maintenance of effects.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)