Prevention of Insomnia in At-risk Youth: A Randomized Controlled Trial Comparing Cognitive Behavioural Prevention Programme for Insomnia With Active Control Condition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Insomnia disorder incidence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Assessors and statisticians, participants will be masked to group allocation.
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Insomnia disorder incidence
时间窗: 12-month follow up
Clinician-rated insomnia incidence is defined as having insomnia symptoms for ≥ 3 times per week for at least one month (will be able to cover both acute and chronic insomnia disorder), accompanied with clinically significant distress or impairment. The assessment will be conducted based on the DSM-V insomnia diagnostic criteria checklist with the detail record of the symptom duration.
Change of insomnia symptoms
时间窗: baseline, week 5, 3-, 6-, and 12-month follow up
The severity of insomnia symptoms as measured by 7-item Insomnia Severity Index (ISI). ISI is a self-report measure designed to assess the nature, severity and impact of insomnia, with a higher total score suggesting more severe insomnia symptoms. Scores range from 0 to 28.
次要结局
- Change of adolescent's perception and attitude towards sleep(baseline, week 5 3-, 6-, and 12-month follow up)
- Change of self-reported cognitive failures(baseline, week 5, 3-, 6-, and 12-month follow up)
- Change of academic performance(baseline and 12-month follow up)
- Change of health related quality of life(baseline, week 5, 3-, 6-, and 12-month follow up)
- Change of sleep hygiene(baseline, week 5, 3-, 6-, and 12-month follow up)
- Change of pre-sleep arousal behaviors(baseline, week 5, 3-, 6-, and 12-month follow up)
- Change of sleep-related thoughts and behaviors(baseline, week 5, 3-, 6-, and 12-month follow up)
- Change of daytime sleepiness(baseline, week 5 3-, 6-, and 12-month follow up)
- Daytime fatigue(baseline, week 5, 3-, 6-, and 12-month follow up)
- Change of anxiety and depressive symptoms(baseline, week 5, 3-, 6-, and 12-month follow up)
- Change of sleep parameters as measured by 7-day sleep diary(baseline, week 5, 3-, 6-, and 12-month follow up)
- Change of score in vulnerability to stress-related insomnia(baseline, week 5, 3-, 6-, and 12-month follow up)
研究者
CHAN NGAN YIN
Research Assistant Professor
Chinese University of Hong Kong