Prevention of Insomnia Using a Stepped Care Model in 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: Cognitive behavioral prevention program for insomnia (CBP-I).
- Кому может быть актуально
- Состояния в реестре: Sleep Disturbance. Базовые параметры: 18 лет — 70 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Prevention of Insomnia Using a Stepped Care Model in Adults: a Pragmatic Stepped-wedge Cluster Randomized Trial
Обзор
Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Our previous study has shown that insomnia can be prevented through a brief cognitive behavioral prevention program in adolescents. However, there is very limited data in the adult population. Current study aims to evaluate a digital sleep-focused platform which consists of different intervention plan according to user's insomnia severity level and employed a stepped care model. Thus, the effectiveness of the stepped care model will be evaluated in a real world setting using stepped wedge cluster randomized controlled design to evaluate potential preventive effect on adults who only with mild insomnia symptoms. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a equally spaced time periods. The primary aim of this study is to evaluate the effects of a stepped-care CBT-I model in improving sleep and prevent the incidence of insomnia among participants with mild insomnia.
Подробное описание
This interventional study will be a multicenter, assessor-blinded, pragmatic stepped-wedge cluster randomized controlled trial. A total of 18 districts will be included in the study and the randomization will be carried out based on the districts. The stepped-care CBT-I intervention will be sequentially rolled out to the 4-6 districts per step according to a computer-generated random number while the remaining clusters will continue to stay unexposed to the CBT-I intervention over the control period. Therefore after 4-step exposure, all clusters will receive the stepped-care CBT-I intervention. A total of 3 follow-up assessments (post intervention, 3-month and 12-month follow up) will be conducted to assess the effectiveness and long-term effects of the stepped care model.
Вмешательства
- Поведенческое Cognitive behavioral prevention program for insomnia (CBP-I)
CBP-I will be provided to participants once their districts are exposed.
Первичные конечные точки
- Insomnia severity index [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month postintervention and 12-month post-intervention follow up]
Вторичные конечные точки (11)
- Severity of depression [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Severity of anxiety [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Health-related quality of life [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Chronic insomnia diagnosis [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Medication usage [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Clinical global impression [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Patient-report clinical global impression [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Sleep duration [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Subjective sleep as measured by sleep diary [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Healthcare resource use [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
- Work and social functioning [Срок оценки: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up]
Критерии участия
Критерии включения
- Chinese adults aged 18-70 years old,
- The score of Insomnia Severity Index < 10.
Критерии исключения
- present with psychotic disorders such as bipolar disorder and schizophrenia,
- present with severe depression or suicidal ideation,
- present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).
- unable to provide 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
- Открытое
- Основная цель
- Профилактика
Центры проведения
Китай · 1 центр
- Department of Psychiatry, the Chinese University of Hong Kong — Гонконг
Идентификаторы
NCT: NCT06156293 · 20230816.02