An interventional study of Cognitive behavioural therapy for insomnia and Sleep hygiene education in Insomnia, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 210 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Cognitive behavioural therapy for insomnia
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.
Behavioral: Cognitive behavioural therapy for insomnia
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.
Behavioral: Sleep hygiene education
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).
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).
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).
Time frame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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.
Time frame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
Change in Quality of life
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.
Time frame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong