Skip to main content
Clinical Trials/NCT07565571
NCT07565571Not yet recruitingNot Applicable

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

Stanford University1 site in 1 country260 target enrollmentStarted: May 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
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.

  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)

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)

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.

Intervention: Intervention WONE App (full Version) (Behavioral)

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.

Intervention: Intervention WONE App (full Version) (Behavioral)

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.

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alan Ching Yuen Yeung

Professor in Medicine

Stanford University

Study Sites (1)

Loading locations...

Similar Trials

Evaluating a Digital Intervention to... | Clinical Trial