A Randomized Controlled Trial to Compare the Effects of Cognitive Behavioral Therapy Workshop, Sleep Hygiene Education Workshop and Self-Help Cognitive Behavioral Therapy on Adults With Sleep Impairment in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change in Insomnia severity
研究概览
简要总结
A randomized controlled trial is proposed to compare the effectiveness of workshop-based and self-Help cognitive behavioral therapy for insomnia (CBTI), and sleep hygiene education (SHE) to treat insomnia in Hong Kong adolescent and adult patients, in terms of alleviation of insomnia severity, reduction in associated insomnia symptoms/ complications, and enhancement in quality of life. Insomnia is prevalent in Hong Kong and can cause severe impacts on patients and society, but there is a dearth of related research in the local population. Therefore, it is significant to conduct this study. A total of 210 participants aged > 18 with insomnia will be recruited and randomized into 3 groups to receive one of the 3 treatments. Outcomes will be measured using relevant questionnaires filled in at the baseline, 6 and 12 weeks afterwards. The results obtained will be compared within each group and among the 3 groups using statistical testing to determine the most effective treatment option for 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
- Double (Investigator, Outcomes Assessor)
盲法说明
After recruitment and assessment for inclusion and exclusion criteria, the participants are randomly assigned with numbers generated by computer and divided equally into 3 groups managed by an independent administrator.
The participants are required to fill in online questionnaires themselves to prevent possible biases during outcome assessments.
The participants will be labelled by numbers without any personal information or intervention group allocated during data analysis.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents
- •Aged 16 or above
- •Satisfy the DSM-5 criteria for insomnia, i.e. inability to fall or keep asleep, or wake up too early for 3 days or more per week, throughout a minimum period of 1 month (instead of 3 months in the diagnostic criteria D) using the Brief Insomnia Questionnaire. This is to include episodic insomnia which is considered as an 'other specified insomnia disorder' in DSM-
- •Score at least 10 points in Insomnia Severity Index
- •Able to read and understand Cantonese
- •Have Internet access
排除标准
- •Suffer from recently diagnosed and untreated medical, psychiatric or sleep disorders that likely contribute to the onset and maintenance of insomnia, e.g. major depressive disorder, obstructive sleep apnea, restless legs syndrome, chronic pain.
- •Currently receiving CBTI or SHE
- •Work on irregular rotational shift
研究组 & 干预措施
CBTI Workshop
The first intervention group (Group 1) will attend one half-day CBTI workshop in the community setting. The workshop is subdivided into 4 sessions, covering topics regarding regulation of stimuli, limit of sleeping duration, relaxation, sleep hygiene and alteration of cognitive beliefs (Arnedt, Cuddihy, & Swanson, et al, 2014; Morin, Savard, Ouellet, & Daley, 2003). One workshop has the capacity of 30 participants.
干预措施: Cognitive behavioural therapy for insomnia (Behavioral)
Self-Help CBTI
The second intervention group (Group 2) will receive self-help CBTI. A CBTI webpage will be set up and the subjects are asked to review all the materials in it. The content is the same as that in Group 1.
干预措施: Cognitive behavioural therapy for insomnia (Behavioral)
SHE Workshop
The control group (Group 3) will receive SHE. To ensure uniformity of the therapy model, the participants will also need to attend one half-day face-to-face session, covering topics related to sleep hygiene only. The capacity is also 30 participants.
干预措施: Sleep hygiene education (Behavioral)
结局指标
主要结局
Change in Insomnia severity
时间窗: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
To identify whether CBTI workshop, self-help CBTI or SHE workshop results in the greatest alleviation of insomnia severity using the Insomnia Severity Index, which allows the patients to rate their perceived severity and satisfaction level towards their current conditions (Arnedt, Cuddihy \& Swanson, et al, 2014; Wong, Zhang \& Li, et al, 2017).
次要结局
- Change in Symptoms of Mood disorders(Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16))
- Change in Quality of life(Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16))
研究者
Dr. Chung Ka-Fai
Clinical Associate Professor
The University of Hong Kong