NCT05011929Unknown不适用
Comparison of the Effects of Support and Non-support Online 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
- 90
- 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 children and adolescents and it has been found to predict the development of mental health problems in young adulthood. Cognitive behavioral therapy for insomnia (CBT-I) has been found to be effective in both adults and adolescents. However, limited accessibility and availability of the treatment has only benefited a small proportion of insomnia patients. Therefore, digital CBT-I has been promoted as an alternative way to manage individual's insomnia problems with adequate efficacy. Nonetheless, one of the major limitations of the online self-help intervention is the relatively high drop-out rate and lower compliance compared to the face-to-face modality which the interactive component is less practical in the online intervention. Therefore, the objectives of current study are 1) evaluate the efficacy of mobile-APP based CBT-I in treating youth insomnia, 2) evaluate whether the provision of additional support could further enhance the treatment outcomes.
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
- Double (Investigator, 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;
- •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 DSM-5 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;
- •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 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months 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 (sleep onset latency)(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of pre-sleep arousal(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of dysfunctional beliefs and attitudes about sleep(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of sleep diary measure (total sleep time)(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of sleep diary measure (wake after sleep onset)(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of daytime fatigue(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of sleep hygiene and practice(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of sleep quality(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of sleep diary measure (total time in bed)(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of sleep diary measure (sleep efficiency)(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of daytime sleepiness(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of quality of life(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of suicidal ideation(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
- Change of self-report mood symptoms(Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups)
研究者
Dr. Shirley Xin Li
Assisitant Professor
The University of Hong Kong
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The Influence of Sleep Education With Social Media Reminders on the Sleep Quality in AdolescentsAdolescent BehaviorNCT05071989Abant Izzet Baysal University60
招募中
不适用
Effects of Cognitive Behavioural Therapy and Bright Light Therapy for Insomnia in Adolescents With Evening ChronotypeDelayed Sleep PhaseInsomniaNCT04256915The University of Hong Kong150
招募中
不适用
Sleeping problems and factors associated in children and adolescents in the metropolitan region of RecifeRBR-9fwkpkniversidade de Pernambuco
Unknown
不适用
Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in YouthInsomniaNCT03522701The University of Hong Kong150
终止
4 期
Insomnia Prevalence and Treatment Impact on Systemic HypertensionHypertensionInsomniaNCT05414864University of Sao Paulo5