Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations (SIER-WONE)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Chloe Yeung
- 電話番号：6502450094
- メール：cayeung@stanford.edu
研究連絡先のバックアップ
- 名前：Alan Yeung, MD
- 電話番号：6507282619
- メール：ayeung@stanford.edu
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford School of Medicine
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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.
|
The Intervention WONE app (Full version) has the following features:
|
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他の：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.
|
The Intervention WONE app (Full version) has the following features:
|
|
他の：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.
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The Intervention WONE app (Full version) has the following features:
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1: Change in Walking on Earth Index (WONE) Index
時間枠：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
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Phase 2: Change in WONE Index
時間枠：Baseline, week 4, week 8, week 12, week 16, week 20, week 24
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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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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