Effectiveness of E-based Cognitive Behavioral Therapy for Insomnia on Improving Mental Health in Chinese Youths With Insomnia: a Large-scale Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 708
- 试验地点
- 2
- 主要终点
- Number of Participants With Major Depressive Disorder
研究概览
简要总结
This study aims to conduct a randomized control trial to validate the treatment effect of e-based cognitive behavioral therapy for Insomnia (e-CBT-I) on insomnia disorder, and explore whether e-CBT-I could prevent depression and suicide in youths with insomnia and subclinical depression. In addition, to further explore the mechanisms underlying the association between insomnia treatments and psychiatric disorders, this study will evaluate whether changes in candidate factors including insomnia symptoms, poor sleep hygiene, sleep-related unhelpful thoughts and maladaptive behaviors, circadian rhythm disruption and chronic sleep deprivation will mediate the effect of e-CBT-I on prevention of depression and suicide.
详细描述
Previous studies have documented the associations of insomnia with depression and suicide. Currently, researchers have done considerable work to investigate whether e-CBT-I could be effective in improving psychological well-being for adults, and previous studies have confirmed that e-CBT-I is effective in reducing depressive symptoms and suicidal ideation in adult population.
However, such studies have not been established in youths yet. Additionally, it is still unclear that by which mechanisms e-CBT-I might affect mental health, and whether e-CBT-I could reduce the risk of depression and suicide.
This study will be the first specifically designed investigation of the preventive effects of e-CBT-I for depression and suicide in youths, and the first large scale causal test of the relationship between insomnia treatments and psychiatric disorders. The results can be expected to influence care provision for the youth population who are at a life stage of emerging adulthood and vulnerable to psychiatric disorders. Further, because the investigators will be using an e-CBT-I approach, a scalable solution may be demonstrated as both feasible and effective. The findings of this study will show the possibility of developing novel preventive intervention for depression and suicide by targeting insomnia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Native Han youths in Hong Kong and mainland China, aged between15-25
- •A diagnosis of insomnia disorder measured by ICD-10 Classification of Mental and Behavioural Disorders
- •The presence of moderate or severe insomnia measured by a score of 15 or above on ISI
- •The presence of subclinical depression assessed by a score of between 4 and 20 on PHQ-9
- •Access to smartphones
- •Ability to read and understand research protocol
排除标准
- •Shift workers
- •The presence of prominent suicidality (suicide plans and suicide attempts) measured by MINI via telephone interview
- •A reported diagnosis of psychosis, schizophrenia, bipolar disorder, or neurodevelopmental disorders
- •Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema
- •An additional sleep disorder (other than insomnia) that may potentially contribute to a disruption in sleep continuity and quality, such as excessive sleepiness and possible obstructive sleep apnoea
- •The presence of current MDD or a prior episode of MDD within past two months measured by MINI via telephone interview
- •Women during pregnancy or lactation
- •Currently receiving psychological treatment for insomnia provided by a psychologist and/or pharmacological treatment for depression
结局指标
主要结局
Number of Participants With Major Depressive Disorder
时间窗: Up to 12-month follow-up
Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).
次要结局
- Change of Insomnia Symptoms(Baseline, post-session 2 (week 3/at the conclusion of session 2), post-session 4 (week 5/at the conclusion of session 4), post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up)
- Percentage of Participants in Remission of Insomnia Disorder(Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up)
- Change of Depressive Symptoms(Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up)
研究者
Professor Wing Yun Kwok
Professor
Chinese University of Hong Kong