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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBTI Workshop | Experimental | 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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| Self-Help CBTI | Experimental | 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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| SHE Workshop | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioural therapy for insomnia | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia severity | 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). | Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptoms of Mood disorders | To identify which of the 3 therapies brings the largest reduction mood disorders through the Hospital Anxiety and Depression Scale. | Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16) |
| Change in Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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A prospective randomized controlled trial (RCT) will be performed to compare the effectiveness of the 3 types of therapies.
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 first intervention group (Group 1) will attend one half-day cognitive behavioural therapy for insomnia (CBTI) workshop in the community setting. The second intervention group (Group 2) will receive self-help CBTI. The control group (Group 3) will receive sleep hygiene education (SHE).
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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.
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| Sleep hygiene education | Behavioral | 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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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. |
| Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16) |
| D001523 |
| Mental Disorders |