NCT03522701Unknown不适用
Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of insomnia symptoms
研究概览
简要总结
Insomnia is the most prevalent sleep problem in both the general and clinical populations. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have been reported in association with adverse outcomes in adolescents, including an increased risk of developing depression, anxiety, interpersonal problems, somatic health problems, self-harm and suicidal ideation. Moreover, adolescent insomnia has been found to predict the development of mental health problems in young adulthood.
Currently there is no medication specifically approved for use as hypnotics in children under age 18 by the US Food and Drug Administration (FDA). Although cognitive behavioural therapy for insomnia (CBT-I) has been regarded as the first-line treatment for insomnia in adults, there exists limited evidence for the efficacy of CBT-I among adolescents and young adults. Given the high prevalence and profound consequences of insomnia among youth, further research on the short-term and long-term effects of CBT-I for adolescents is warranted. To address the limitations of the existing literature, this randomised controlled trial aims to examine whether face-to-face (group-based CBT-I) versus self-help insomnia treatment benefit adolescents with insomnia, for improving sleep and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese aged 12-24 years old (according to World Health Organization's defined age range for youth);
- •Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- •Being able to comply with the study protocol;
- •Having a diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents)
排除标准
- •A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
- •Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
- •Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the Diagnostic Interview for Sleep Patterns and Disorders (DISP);
- •Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
- •In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
- •Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
- •Initiation of or change in antidepressant medication within past 2 months;
- •Having been or is currently receiving any structured psychotherapy;
- •With hearing or speech deficit;
- •Night shift worker.
结局指标
主要结局
Change of insomnia symptoms
时间窗: Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
次要结局
- Change of sleep diary measure (wake after sleep onset, WASO)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep quality(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep diary measure (sleep onset latency, SOL)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups])
- Change of sleep diary measure (total sleep time, TST)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep diary measure (sleep efficiency, SE)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep diary measure (time in bed, TIB)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups])
- Change of objective sleep measure (sleep onset latency, SOL)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective sleep measure (wake after sleep onset, WASO)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of daytime sleepiness(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of objective cognitive performance (inhibitory ability)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective cognitive performance (episodic memory)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective sleep measure (time in bed, TIB)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective sleep measure (total sleep time, TST)(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective cognitive performance (problem solving)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of daytime fatigue(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of quality of life(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of suicidal ideation(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of self-report mood symptoms(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of depressive symptoms (assessor-rated)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of overall severity of clinical symptoms(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of dysfunctional beliefs and attitudes about sleep(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of sleep hygiene and practice(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups)
- Change of pre-sleep arousal(Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups])
- Change of objective cognitive performance (visual attention & task switching)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective cognitive performance (working memory by digit span)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of sleep related attention bias(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of objective cognitive performance (working memory by N-Back)(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
- Change of risk-taking & decision making(Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups)
研究者
Dr. Shirley Xin Li
Assistant Professor
The University of Hong Kong
研究点 (1)
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