Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy (CBT-I) in Reducing Insomnia Symptoms Among the Adult Population: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Change from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment
研究概览
简要总结
This experimental study aims to develop an internet-based self-help cognitive behavioural therapy for insomnia that reduces insomnia symptoms and its associated adverse outcomes among people with sub-threshold insomnia symptoms. In particular, this study compares the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population.
The online CBT-I course will consist of an introductory module, followed by 6 weekly modules. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.
详细描述
Although the Internet self-help CRT-I program have shown promising effect on dealing with insomnia symptoms, the effectiveness of internet self-help CBT-I in adults with sub-clinical insomnia symptoms in Hong Kong is under-studied. Therefore, the present study aimed to compare the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population. We hypothesized that (1) participants who received CBT-I treatment would have improved insomnia symptoms after the intervention as compared with the wait-list controls; (2) participants from CBT-I would have better sleep hygiene, and less dysfunctional beliefs about sleep and pre-sleep arousal after the intervention as compared with the wait-list controls; (3) participants from CBT-I would have improved mental health, daytime functioning, quality of life, and general well-being after treatment, as compared with the wait-list controls.
The online CBT-I course will consist of an introductory module, followed by 6 weekly modules, incorporating the key CBT-I components, including sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents
- •Age ≥18 years
- •Insomnia Severity Index score > 7 and < 22
- •Being able to read Chinese
- •Have a computer, tablet and/or smartphone device with Internet access
- •have a regular email address
- •Willing to give informed consent and comply with the trial protocol
排除标准
- •Receiving psychological treatment at least once per month
- •Currently taking prescribed psychiatric drugs such as antidepressants, tranquilizers, and sleeping pills regularly
- •Carrying a diagnosis of psychosis or schizophrenia
- •Participating in any other academic studies or clinical trials related to insomnia
- •Having current suicidal plans or acts or having had suicidal plans or acts within the past 12 months
- •Shift workers
结局指标
主要结局
Change from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment
时间窗: Before intervention, Immediately after intervention, and 4 weeks after intervention
The ISI assesses the change in a 5-point Likert scale, ranging from 1 (none/ very dissatisfied/ not at all noticeable, worried \& interfering) to 5 (very severe/ very satisfied/ very much noticeable, worried \& interfering).
次要结局
- Change from Baseline Assessment in General Sleep Disturbances on the Pittsburgh Sleep Quality Index (PSQI) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Change from Baseline Assessment in Psychological Wellbeing on the World Health Organisation-Five Well-Being Index (WHO-5) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Change from Baseline Assessment in Daily Sleep-Wake Schedule on the 7-Day Consensus Sleep Diary at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Change from Baseline Assessment in Cognitive and Somatic Manifestations of Arousal on the Pre-sleep Arousal Scale (PSAS) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Change from Baseline Assessment in Sleep Related Cognition on the Dysfunctional Beliefs and Attitudes about Sleep (DBAS) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Change from Baseline Assessment in Psychological Distress on the Short Form of the Depression, Anxiety, and Stress Scale (DASS-21) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Change from Baseline Assessment in Functional Impairment of Insomnia on the Work and Social Adjustment Scale (WSAS) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Treatment Satisfaction in internet (Acceptability of the Internet for delivering CBT) at the Interview after Post-Intervention Assessment(Immediately after Post-Intervention Assessment)
- Change from Baseline Assessment in Sleep Habits on the Sleep Hygiene Practice Scale (SHPS) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Treatment Adherence at the Interview after Post-Intervention Assessment(Immediately after Post-Intervention Assessment)
- Change from Baseline Assessment in Quality of Life on the Twelve-Item Short-Form (SF-12) Health Survey at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Change from Baseline Assessment in Expectation toward Intervention on the Credibility of Treatment Rating Scale (CTRS) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
- Insomnia Treatment Acceptability assessed the Insomnia Treatment Acceptability Scale (ITAS) at the Interview after Post-Intervention Assessment(Immediately after Post-Intervention Assessment)
- Treatment Satisfaction at the Interview after Post-Intervention Assessment(Immediately after Post-Intervention Assessment)
- Change from Baseline Assessment in Cognitive Failure on the Measure of Insight into Cognition-Self Report (MIC-SR) at Post-Intervention Assessment and Follow-up Assessment(Before intervention, Immediately after intervention, and 4 weeks after intervention)
研究者
CHAN Ka Shing Kevin
Associate Professor, Head of Department of Psychology
Education University of Hong Kong