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

27 aprile 2026 aggiornato da: Alan Ching Yuen Yeung, Stanford University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

260

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • California
      • Stanford, California, Stati Uniti, 94305
        • Stanford School of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Comportamentale: 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.
Altro: 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.
Comportamentale: 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.
Altro: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 1: Change in Walking on Earth Index (WONE) Index
Lasso di tempo: 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.
Baseline, week 4, week 8
Phase 2: Change in WONE Index
Lasso di tempo: 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.
Baseline, week 4, week 8, week 12, week 16, week 20, week 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Stanford University

Collaboratori

Walking on Earth Ltd.

Investigatori

  • Investigatore principale: Alan Yeung, MD, Stanford University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 84749

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Benessere mentale

Prove cliniche su Intervention WONE App (full Version)

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