Low-intensity Cognitive-behavioural Therapy for Insomnia

The University of Hong Kong (HKU)

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Sleep hygiene education; Behavioral: Cognitive behavioural therapy for insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT03736694

UW 18-396

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups

CBTI Workshop

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive behavioural therapy for insomnia

Self-Help CBTI

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive behavioural therapy for insomnia

SHE Workshop

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep hygiene education