NCT05270369已完成不适用
Effects of Group-based and Digitally Delivered Cognitive Behavioural Therapy for Insomnia (CBT-I) in Youth: a Randomised Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Change of insomnia symptoms
研究概览
简要总结
Adolescence is a critical transitional stage characterised by a cascade of developmental changes in biological, cognitive, and psychological functioning. Sleep problems, particularly insomnia, are prevalent in adolescents, with a prevalence rate as high as 36%. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have often 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. This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in reducing insomnia severity in youth with insomnia.
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
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Chinese aged 12-20 years old (an age range that was similarly adopted in the previous studies to cover a wider developmental span in adolescence);
- •(2) Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- •(3) Willing to comply with the study protocol;
- •(4) Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) - 9 (suggested cut-off for adolescents)
排除标准
- •(1) 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;
- •(2) Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
- •(3) 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 Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (ICSD) criteria;
- •(4) Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter (OTC) medications (e.g. melatonin, Traditional Chinese Medicine, TCM);
- •(5) Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
- •(6) In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by Mini-International Neuropsychiatric Interview (MINI);
- •(7) Currently receiving any structured psychotherapy;
- •(8) With hearing or speech deficit; (9) Night shift worker.
结局指标
主要结局
Change of insomnia symptoms
时间窗: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups
Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 7-item self-rated scale. Possible scores range from 0 to 28, with higher scores indicating higher insomnia severity.
次要结局
- Change of Self-report states of depression and anxiety symptoms(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Self-report emotional states of depression, anxiety and stress(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Self-report depressive symptoms(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of subjective mental well-being(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of dysfunctional beliefs and attitudes about sleep(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of sleep hygiene and practice(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of pre-sleep arousal(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of sleep reactivity(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Suicidal Ideation(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Daytime Sleepiness(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Daytime Fatigue(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change in Sleep Quality(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Sleep Diary Measure - Time in Bed (TIB)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Sleep Diary Measure - Total Sleep Time (TST)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Sleep Diary Measure - Sleep Onset Latency (SOL)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change in Objective Sleep Measures - Time in Bed (TIB)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Sleep Diary Measure - Sleep Efficiency (SE)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change in Objective Sleep Measures - Total Sleep Time (TST)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of objective sleep measure (sleep onset latency, SOL)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change in Objective Sleep Measures - Sleep Efficiency (SE)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Depressive Symptoms (Assessor-rated)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Quality of Life (KIDSCREEN-27)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Overall Severity of Clinical Symptoms(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Objective Cognitive Performance (visual attention & task switching)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Objective Cognitive Performance (inhibitory ability)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Objective Cognitive Performance (working memory by digit span)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Objective Cognitive Performance (working memory by N-Back)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Objective Cognitive Performance (episodic memory)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of Objective Cognitive Performance (problem solving)(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of sleep related attention bias(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of risk-taking & decision making(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of implicit cognition of suicide or death(Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants, and additional two follow-ups at Post-Treatment 6-month and Post-Treatment 12-month for participants in the treatment groups)
- Change of emotion regulation abilities(Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants)
- Change of emotion regulation tendency/capacity(Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants)
- Change of ability/efficiency in using different emotion regulation strategies(Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants)
- Change of verbal fluency(Time Frame: Baseline, Post-Treatment (one-week after completion of the intervention/waiting period) for all participants)
研究者
Dr. Shirley Xin Li
Assistant Professor
The University of Hong Kong
研究点 (1)
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