Low-intensity Cognitive-behavioural Therapy for Insomnia
2020年3月23日 更新者：Dr. Chung Ka-Fai、The University of Hong Kong
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
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.
研究概览
研究类型
介入性
注册 (实际的)
210
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Hong Kong、香港
- The University of Hong Kong
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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-5.
- Score at least 10 points in Insomnia Severity Index
- Able to read and understand Cantonese
- Have Internet access
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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CBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, & Daley, 2003).
It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, & Denberg, 2016).
CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, & Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, & Brown, 2012).
Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, & Meijer, 2015).
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实验性的：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.
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CBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, & Daley, 2003).
It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, & Denberg, 2016).
CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, & Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, & Brown, 2012).
Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, & Meijer, 2015).
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有源比较器：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.
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SHE, is commonly provided verbally or through leaflets during consultations (Espie, 2009), and is also included as a part of CBTI (Morin, Savard, Ouellet, & Daley, 2003).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Insomnia severity
大体时间：Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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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).
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Symptoms of Mood disorders
大体时间：Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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To identify which of the 3 therapies brings the largest reduction mood disorders through the Hospital Anxiety and Depression Scale.
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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Change in Quality of life
大体时间：Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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To investigate which of the 3 therapies improves the quality of life of patients to the greatest extent using the Short-Form Six-Dimension Health Survey.
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年9月1日
初级完成 (实际的)
2019年6月30日
研究完成 (实际的)
2019年7月31日
研究注册日期
首次提交
2018年11月7日
首先提交符合 QC 标准的
2018年11月8日
首次发布 (实际的)
2018年11月9日
研究记录更新
最后更新发布 (实际的)
2020年3月25日
上次提交的符合 QC 标准的更新
2020年3月23日
最后验证
2020年3月1日
更多信息
与本研究相关的术语
其他研究编号
- UW 18-396
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