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

27. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

260

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Adfærdsmæssigt: 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.
Andet: 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.
Adfærdsmæssigt: 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.
Andet: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Phase 1: Change in Walking on Earth Index (WONE) Index
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stanford University

Samarbejdspartnere

Walking on Earth Ltd.

Efterforskere

  • Ledende efterforsker: Alan Yeung, MD, Stanford University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 84749

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Mentalt velvære

Kliniske forsøg med Intervention WONE App (full Version)

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