Clinical trial NCT03736694: Low-intensity Cognitive-behavioural Therapy for Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Cognitive behavioural therapy for insomnia
Sleep hygiene education
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 210
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Insomnia severity
timeFrame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
Secondary outcomes:
measure: Change in Symptoms of Mood disorders
timeFrame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
measure: Change in Quality of life
timeFrame: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References: