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Набор скоро начнётся NCT07565571

Evaluating a Digital Intervention to Improve Resilience and Reduce Stress in Stanford Populations

Без фазы С лечением Resilience, Psychological Mental Well-being

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intervention WONE App (full Version).
Кому может быть актуально
Состояния в реестре: Resilience, Psychological, Mental Well-being. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Phase 1: Change in Walking on Earth Index (WONE) Index [Срок оценки: Baseline, week 4, week 8]
  • Phase 2: Change in WONE Index [Срок оценки: Baseline, week 4, week 8, week 12, week 16, week 20, week 24]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Stanford School of Medicine — Stanford

Идентификаторы

NCT: NCT07565571 · 84749

Первоисточники (государственные реестры)

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