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Идёт набор NCT06853106

Digital Sleep Program for College Students with Insomnia

Без фазы С лечением Insomnia

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: Waitlist control group, digital-based multimodal sleep management program.
Кому может быть актуально
Состояния в реестре: Insomnia. Базовые параметры: 18 лет — 26 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
Тайвань
Следующий шаг
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Официальное название

Digital-Based Multimodal Sleep Management Program for College Students with Insomnia: Randomized Controlled Trial

Обзор

This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress, as well as psychological health indices, such as depression, anxiety, and resilience. Additionally, this study seeks to examine the mediating role of different chronotypes in the effectiveness of the sleep intervention on the outcomes of interest.

Подробное описание

This is a parallel-group, randomized controlled trial (RCT). 90 participants who experiencing insomnia for at least 3 months with college students will be enrolled.

Eligible participants who complete the baseline measurements will be randomly allocated to a digital-based multimodal sleep management program group (N = 45) and a waitlist control group (N = 45).

The primary outcome is insomnia severity, assessed using the Insomnia Severity Index (ISI). The secondary outcomes include daytime sleepiness, objective sleep parameters, sleep reactivity, resilience, anxiety, and depression, which will be examined using the Epworth Sleepiness Scale (ESS), a wearable sleep tracker, the Ford Insomnia Response to Stress Test (FIRST), the Brief Resilience Scale (BRS), the State-Trait Anxiety Inventory (STAI), and the Beck Depression Index II (BDI-II), respectively. Additionally, chronotype will be assessed using the Morningness-Eveningness Questionnaire (MEQ) as a moderating role to be tested in this study. All outcomes will be measured at three time points: T0 (baseline assessment), T1 (immediately after the 4-week intervention period), and T2 (4 weeks after the intervention period).

Вмешательства

  • Другое Waitlist control group
    The participants in the waitlist control group will be informed that they are on a waiting list during the intervention period, serving as a no-treatment control. They will receive the sleep intervention (i.e., the digital-based sleep management program) four weeks after the intervention period is completed.
  • Поведенческое digital-based multimodal sleep management program
    The digital-based multimodal sleep management program consists of (1) sleep hygiene education, (2) sleep restriction, and (3) mindfulness breathing exercises. The program is internet-integrated and delivered via Google Meet, with 45-minute weekly sessions over four weeks. To increase participants' adherence to the sleep management program , the course instructor will request the participants to record their daily sleep diaries (time to bed, time to sleep, wake time during sleep and wake time) an

Первичные конечные точки

  • Insomnia Severity:The Insomnia Severity Index (ISI) [Срок оценки: T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.]
Вторичные конечные точки (6)
  • Daytime Sleepiness:The Epworth Sleepiness Scale (ESS) [Срок оценки: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention.]
  • Sleep Parameters [Срок оценки: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]
  • Sleep Reactivity: The Chinese version of the Ford Insomnia Response to Stress Test (FIRST) [Срок оценки: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]
  • Resilience: The Chinese version of the Brief Resilience Scale (BRS) [Срок оценки: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]
  • Depression: The Beck Depression Index II (BDI II) [Срок оценки: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]
  • Anxiety: The State Trait Anxiety Inventory (STAI) [Срок оценки: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention]

Критерии участия

Критерии включения

  • Registered as a full-time student
  • Aged 18 to 26 years old
  • Experiencing insomnia for at least three months
  • Currently own and use a personal mobile device
  • Ability to read and speak Chinese
  • Not taking hypnotics, sedatives, or antidepressants
  • Not pregnant or lactating

Критерии исключения

  • Using a smartphone model that cannot support the app
  • Currently using other sleep program apps
  • Meeting a STOP-BANG score of ≥3

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • Taipei Medicine University — Taipei

Идентификаторы

NCT: NCT06853106 · N202401041

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗