Prevention of Insomnia in At-risk Youth

Официальное название

Prevention of Insomnia in At-risk Youth: A Randomized Controlled Trial Comparing Cognitive Behavioural Prevention Programme for Insomnia With Active Control Condition

Обзор

This study aims to conduct a randomized controlled trial in comparing cognitive behavioral insomnia prevention program with the active control group in youths who are at risk of insomnia. The results of this study will allow us to take this potential efficacious prevention program to scale and reduce the associated burden of insomnia in the future.

Подробное описание

Adolescence is a vulnerable period for the emergence of insomnia, which affects more than 10% of the youths (approximately 40% if based on symptoms). Insomnia in youths tends to run a protracted course and is associated with numerous negative outcomes including poor quality of life, cognitive and academic impairment, and predisposing to development of depression and anxiety. The burden arises from insomnia has been increasingly recognized worldwide as a debilitating and costly public health concern.

However, insomnia in youths is often ignored and under-treated, with only 10% of the local youths recognized their insomnia problem and none of them has received the recommended first-line treatment - cognitive behavioral therapy for insomnia (CBT-I). Given the high prevalence, chronicity and long-lasting health-related consequences of insomnia, together with the delay and limited help-seeking behavior, it calls the urgent need for early insomnia prevention and intervention in this vulnerable population.

Thus, this study aims to conduct a randomized controlled trial in comparing cognitive behavioral insomnia prevention program with the active control group in youths who are at risk of insomnia and to explore the effect of prevention program in preventing the incidence of insomnia problems.

Вмешательства

• Поведенческое Insomnia prevention program
  Youths in the intervention group will receive 4 weekly insomnia prevention program. Each session will last for about 60-90 mins.
• Поведенческое General health education
  Youths in the control group will be provided with group-based general health education with same dosage (4 weeks) as intervention group.

Первичные конечные точки

• Insomnia disorder incidence [Срок оценки: week 5]
• Insomnia disorder incidence [Срок оценки: 3-month follow up]
• Insomnia disorder incidence [Срок оценки: 6-month follow up]
• Insomnia disorder incidence [Срок оценки: 12-month follow up]
• Change of insomnia symptoms [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]

Вторичные конечные точки (12)

• Change of sleep parameters as measured by 7-day sleep diary [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of score in vulnerability to stress-related insomnia [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of sleep-related thoughts and behaviors [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of daytime sleepiness [Срок оценки: baseline, week 5 3-, 6-, and 12-month follow up]
• Daytime fatigue [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of self-reported cognitive failures [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of anxiety and depressive symptoms [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of health related quality of life [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of sleep hygiene [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of pre-sleep arousal behaviors [Срок оценки: baseline, week 5, 3-, 6-, and 12-month follow up]
• Change of academic performance [Срок оценки: baseline and 12-month follow up]
• Change of adolescent's perception and attitude towards sleep [Срок оценки: baseline, week 5 3-, 6-, and 12-month follow up]

Критерии участия

Критерии включения

• Youth aged between 15-24 years (as defined by WHO);
• Written informed consent of participation into the study is given by youth and his/her parents if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old;
• Have subclinical insomnia symptoms (at least once a month but less than 3 times/week in the past one month);
• At least one of the biological parents with current or lifetime history of insomnia disorder as defined by DSM-V diagnostic criteria.

Критерии исключения

• A current or past history of neuropsychiatric disorder(s);
• A prominent medical condition or taking medication with potential side effects that may influence sleep quantity and quality;
• Having a diagnosed sleep disorder that may potentially contribute to the disruption of sleep quantity and quality as ascertained by both Structured Diagnostic Interview for Sleep patterns and Disorders (DISP) such as insomnia, delayed sleep phase and narcolepsy, restless leg syndrome;
• Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
• Currently receiving any structured psychotherapy;
• With hearing or speech deficit;
• Trans-meridian flight in the past 3 months and during the study.

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

Профилактика

Центры проведения

Гонконг · 1 центр

• Department of Psychiatry — Shatin

Идентификаторы

NCT: NCT05451524 · 2021.005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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