Меню
Набор скоро начнётся NCT07230899

Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong

Без фазы С лечением Mental Distress 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: Cognitive Behavioral Therapy for Insomnia.
Кому может быть актуально
Состояния в реестре: Mental Distress, Insomnia. Базовые параметры: 12 лет — 24 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
Список центров уточняется — проверьте первичный протокол.
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

A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong

Обзор

This randomized controlled trial (RCT) aims to evaluate the effectiveness of a Cognitive Behavioral Therapy for Insomnia (CBTi) intervention in enhancing sleep quality, overall quality of life, functional ability, and reducing mental distress among at-risk youths in Hong Kong. Participants are youths with moderate mental health concerns, indicated by K6 scores ranging from 11 to 14. The study involves 160 participants who will be randomly assigned to either the intervention group or a wait-list control group. Participants assigned to the intervention group will receive six weekly face-to-face sessions led by trained youth workers, while those in the control group will receive the same intervention after the initial follow-up period. Participants will be evaluated at baseline, post-intervention, and one-month follow-up. An interim analysis is built for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. Furthermore, a qualitative follow-up will be conducted after the trial, involving both participants and the workers delivering the CBTi intervention. This qualitative component aims to gather feedback on participants' experiences, and inform potential revisions to enhance future implementation. It is hypothesized that youths receiving the CBTi intervention will show significantly greater improvements in sleep quality, quality of life, and functioning, along with reductions in mental distress, as well as depressive and anxiety symptoms, compared to those in the wait-list control group.

Вмешательства

  • Поведенческое Cognitive Behavioral Therapy for Insomnia
    Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.

Первичные конечные точки

  • Sleep Quality and Disturbance [Срок оценки: Baseline, 6-week, 10-week]
  • Insomnia Severity [Срок оценки: Baseline, 6-week, 10-week]
Вторичные конечные точки (7)
  • Psychological Distress [Срок оценки: Baseline, 6-week, 10-week]
  • Depression [Срок оценки: Baseline, 6-week, 10-week]
  • Depression and Anxiety Symptoms [Срок оценки: Baseline, 6-week, 10-week]
  • Anxiety [Срок оценки: Baseline, 6-week, 10-week]
  • Social and Occupational Functioning [Срок оценки: Baseline, 6-week, 10-week]
  • Health-related Quality of Life [Срок оценки: Baseline, 6-week, 10-week]
  • Health-related Quality of Life [Срок оценки: Baseline, 6-week, 10-week]

Критерии участия

Критерии включения

  • JC LevelMind @ Community users at least at risk for mild mental distress (Tier 2), with K6 scores above or equal to 11, or clinicians' endorsement after reviewing the case to have other issues/problems
  • Aged between 12 and 24 years
  • Insomnia Severity Index (ISI) score greater than 7
  • Sufficiently proficient in Chinese to comprehend verbal instructions
  • Able to provide written informed consent (parental consent for participant aged 12-17)

Критерии исключения

  • Young people with mild distress (K6 scores between 0 and 10)
  • Known diagnosis of intellectual disability
  • Organic brain disorder
  • Established psychiatric diagnosis
  • Current substance abuse
  • Receiving other structured psychological therapies such as module-based psychological therapy, mentalization-based therapy, low-intensity online interventions, cognitive-behavioral therapy, narrative therapy, mindfulness, or art-informed therapy within the hub setting or any others outside the hub setting
  • Presence of current or active suicidal ideation or attempts

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
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07230899 · 20250818-002-000

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗