Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations (SIER Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Phase 1: Change in Walking on Earth Index (WONE) Index
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intervention WONE App (full Version) (Behavioral)
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.
干预措施: Intervention WONE App (full Version) (Behavioral)
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.
干预措施: Intervention WONE App (full Version) (Behavioral)
结局指标
主要结局
Phase 1: Change in Walking on Earth Index (WONE) Index
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Alan Ching Yuen Yeung
Professor in Medicine
Stanford University