Low-intensity Cognitive-behavioural Therapy for Insomnia
- Conditions
- Insomnia
- Registration Number
- NCT03736694
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Insomnia severity 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).
- Secondary Outcome Measures
Name Time Method Change in Symptoms of Mood disorders Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16) To identify which of the 3 therapies brings the largest reduction mood disorders through the Hospital Anxiety and Depression Scale.
Change in Quality of life Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16) 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.
Trial Locations
- Locations (1)
The University of Hong Kong
🇭🇰Hong Kong, Hong Kong
The University of Hong Kong🇭🇰Hong Kong, Hong Kong