Resilience, PsychologicalSIER-WONENCT07565571
Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations
A study testing Intervention WONE App (full Version) in people with Resilience, Psychological and Mental Well-being, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Psychological, Mental Well-being
- What is being tested?
- Intervention WONE App (full Version)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford School of Medicine
Stanford, California, 94305
About this study
Official title: 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.
Read the 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)
- Assess feasibility and acceptability of the WONE digital intervention over 8 weeks.
- 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.
- Describe engagement patterns and examine whether engagement relates to changes in outcomes.
- Assess feasibility of wearable integration, including connection rates and data completeness.
Phase 2 Objectives (Randomized Crossover RCT)
- Test the efficacy of the WONE intervention compared to a control period using a 12-week crossover design.
- 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.
- Investigate engagement as a predictor of improvement.
- Evaluate maintenance of effects at the 6-month follow-up.
- Conditions
- Resilience, Psychological, Mental Well-being
- Being tested
- Intervention WONE App (full Version)
- Keywords
- resilience, entrepreneurs, mental well-being, stanford, WONE
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention WONE App (full Version)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Intervention WONE App (full Version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, week 4, week 8, week 12, week 16, week 20, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resilience, PsychologicalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Walking on Earth Ltd.
- Responsible party
- Principal investigator, Alan Ching Yuen Yeung, Stanford University
- Investigators
- Alan Yeung, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565571
- Sponsor's protocol ID
- 84749
- Acronym
- SIER-WONE
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations (SIER Study)
- ClinicalTrials.gov ID
- NCT07565571
- Acronym / sponsor ID
- SIER-WONE / 84749
- Conditions
- Resilience, Psychological, Mental Well-being
- Keywords
- resilience, entrepreneurs, mental well-being, stanford, WONE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Walking on Earth Ltd.
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- Assess feasibility and acceptability of the WONE digital intervention over 8 weeks.
- 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.
- Describe engagement patterns and examine whether engagement relates to changes in outcomes.
- Assess feasibility of wearable integration, including connection rates and data completeness.
Phase 2 Objectives (Randomized Crossover RCT)
- Test the efficacy of the WONE intervention compared to a control period using a 12-week crossover design.
- 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.
- Investigate engagement as a predictor of improvement.
- Evaluate maintenance of effects at the 6-month follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 2: Control (Weeks 1-12) then Intervention (Weeks 13-24) | Other | Behavioral: Intervention WONE App (full Version)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. |
| Phase 2: Intervention (Weeks 1-12) then Control (Weeks 13-24) | Other | Behavioral: Intervention WONE App (full Version)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. |
| Phase 1 (pilot, single arm) | Other | Behavioral: Intervention WONE App (full Version)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Severe psychiatric instability, defined as any of the following self-reported on the pre-enrollment screener:
- No smartphone or unwilling to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 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) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Yeung, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention WONE App (full Version) in people with Resilience, Psychological and Mental Well-being, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloe Yeung (6502450094, cayeung@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Change in Walking on Earth Index (WONE) Index (time frame: Baseline, week 4, week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.