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Набор скоро начнётся NCT07642479

A Theory-based Sleep Hygiene Education for Insomnia Disorder

Без фазы С лечением Insomnia Adults

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: Sleep Hygiene Education, CBT-I Apps.
Кому может быть актуально
Состояния в реестре: Insomnia, Adults. 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Theory-based Sleep Hygiene Education for Insomnia Disorder - A Non-inferiority Randomized Controlled Trial With Mixed-method Process Evaluation and Cost-effectiveness Analysis

Обзор

Insomnia is a prevalent sleep disorder associated with numerous adverse health outcomes, including fatigue, irritability, and impaired daytime functioning. Despite the availability of effective pharmacological and psychological treatments, relatively few individuals with insomnia seek professional help, highlighting the need for accessible and acceptable non-pharmacological interventions. Sleep hygiene education (SHE) has the potential to address this gap due to its simplicity, low cost, and ease of self-administration. Building on our previously registered pilot-testing protocol, this study aims to examine the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community population. Furthermore, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as cognitive behavioral therapy for insomnia (CBT-I) delivered via digital applications. Therefore, this study will also compare the effectiveness of theory-based SHE with a CBT-I app using a three-arm randomized controlled trial design.

Подробное описание

Insomnia is a prevalent sleep disorder associated with substantial adverse health consequences, including fatigue, irritability, and impaired daytime functioning. Although effective pharmacological (e.g., hypnotics) and psychological treatments (e.g., cognitive behavioral therapy for insomnia, CBT-I) are available, both local and international surveys indicate that fewer than 50% of individuals with insomnia seek treatment. This treatment gap underscores the need for effective non-pharmacological interventions that are both accessible and acceptable.

Sleep hygiene education (SHE) represents a potentially suitable approach to address this unmet need. SHE is an educational intervention encompassing a range of lifestyle and environmental recommendations to optimize sleep quality and duration. These include maintaining a regular sleep-wake schedule, avoiding substances such as caffeine, nicotine, and alcohol, limiting daytime napping and stimulating activities before bedtime, optimizing the sleep environment, and adopting appropriate dietary and exercise habits etc. Given its simplicity, low cost, accessibility, and ease of delivery and adoption, SHE holds promise as a non-pharmacological strategy for insomnia management.

Despite these advantages, SHE is not typically recommended as a stand-alone treatment for individuals with sleep problems, as it is often perceived to be less effective than CBT-I or mindfulness-based interventions, with consistently small effect sizes reported. However, these findings should be interpreted with caution. In many previous studies, SHE has primarily been used as a passive control condition to account for nonspecific treatment effects, thereby underexploiting its active therapeutic potential. Moving SHE beyond a simple advice-giving modality to a structured, theory-informed approach may optimize its effectiveness by ensuring its content is informative and promising. Integrating SHE with established behavior change techniques may better equip individuals with the skills needed to initiate and sustain meaningful behavioral change.

Building on our previously registered pilot-testing protocol, this study aims to evaluate the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community sample. In addition, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as digitally delivered CBT-I. This study will also examine whether a theory-based SHE program is a cost-effective approach for reducing insomnia severity in adults with insomnia disorder compared with a CBT-I app and a no-intervention control. To address these objectives, a three-arm randomized controlled trial will be conducted to compare the relative effectiveness of these interventions.

Вмешательства

  • Поведенческое Sleep Hygiene Education
    Participants in this group will receive a structured six-week SHE intervention. The intervention includes two weekly 2-hour group-based, face-to-face educational sessions (total 4 hours) conducted in a classroom at the School of Nursing, The Hong Kong Polytechnic University, followed by four weekly individualized telephone consultations lasting approximately 10 minutes each. During the educational sessions, participants will receive education on insomnia and evidence-based sleep hygiene practice
  • Поведенческое CBT-I Apps
    Participants in this group will receive a CBT-I program consisting of six weekly modules delivered in the Chinese language through a smartphone application proACT-S. The duration of each module is around 45 to 60 min with interactive features. The self-help CBT-I treatment content in proACT-S is based on the Chinese translated version of a well-established CBT-I treatment manual. The self-help CBT-I treatment content is designed to alter dysfunctional cognitive beliefs and maladaptive behaviors

Первичные конечные точки

  • The Insomnia Severity Index (ISI) [Срок оценки: Baseline, week 6, week 12 and week 24]
Вторичные конечные точки (10)
  • Sleep Onset Latency Measured By Sleep Diary [Срок оценки: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)]
  • Wake After Sleep Onset Measured By Sleep Diary [Срок оценки: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)]
  • Sleep Efficiency Measured By Sleep Diary [Срок оценки: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)]
  • Total Sleep Time Measured By Sleep Diary [Срок оценки: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)]
  • The Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline, week 6, week 12 and week 24]
  • The Short-Form Six Dimensions (SF-6D) [Срок оценки: Baseline, week 6, week 12 and week 24]
  • Sleep Onset Latency Measured By Actigraphy [Срок оценки: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)]
  • Wake After Sleep Onset Measured By Actigraphy [Срок оценки: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)]
  • Sleep Efficiency Measured By Actigraphy [Срок оценки: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)]
  • Total Sleep Time Measured By Actigraphy [Срок оценки: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)]

Критерии участия

Критерии включения

  • Hong Kong residents
  • Ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua
  • Who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire
  • Scored at least 10 points in the Insomnia Severity Index
  • Willing to give informed consent

Критерии исключения

  • Any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV
  • Other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment
  • Any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia
  • Taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders
  • Impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions
  • Pregnant
  • Shift work

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • School of Nursing, The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07642479 · SHCI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗