An interventional study of Lay-led CBT-I brief group and Booklet on sleep health in Sleep Quality, sponsored by The University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to study whether a Cognitive Behavioural Therapy for Insomnia (CBT-I) group led by laypersons serves as an effective tool for alleviating insomnia in older Chinese adults in Hong Kong. The main questions it aims to answer are: 1) Can the group improve subjective sleep quality? 2) What is the feasibility and acceptability of the group? Researchers will compare the intervention group with a control group. Participants will either join the intervention group or receive a self-help booklet, depending on their assignment. Both groups will complete two questionnaires over a four-week period: Baseline and Week-4 data.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 50 is below the median of 68 across 2,350 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 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a booklet on sleep hygiene education and will be asked to follow the instruction for 4 weeks for the same duration as the intervention group.
Behavioral: Booklet on sleep health
A brief in-person group for CBT-I, consisting of four sessions, with each session lasting approximately 1.5 hours and expected to be completed within a month. The sessions will cover four treatment components: sleep hygiene, stimulus control, cognitive restructuring, and relaxation exercises, all facilitated by trained Emotional Support Assistants.
Behavioral: Lay-led CBT-I brief group
Participants will participate in a brief in-person group for CBT-I, consisting of four sessions, with each session lasting approximately 1.5 hours and expected to be completed within a month. The sessions will cover four treatment components: sleep hygiene, stimulus control, cognitive restructuring, and relaxation exercises, all facilitated by trained Emotional Support Assistants.
Eligible control group participants will receive a booklet on sleep hygiene education.
Subjective sleep quality
Brief Version of the Pittsburgh Sleep Quality Index (B-PSQI): Likert scale with a global scoring ranging from 0 to 15. A higher score indicates worse sleep quality.
Time frame: From first session to last session at 4 weeks.
Dysfunctional Beliefs and Attitudes about Sleep
A 16-items scale ranging from 0 (Strongly Disagree) to 10 (Strongly Agree). Stronger endorsement of these beliefs indicates greater maladaptation in detecting therapeutic changes and effectiveness.
Time frame: From first session to last session at 4 weeks.
Pre-sleep Arousal Scale
Rated on a 5-point Likert scale, ranging from 1 (Not at all) to 5 (Extremely), with total scores ranging from 8 to 40 for both subscales. Higher scores indicate an increased level of pre-sleep arousal.
Time frame: From first session to last session at 4 weeks.
PDFs hosted by the registry, ClinicalTrials.gov.
Start is estimated for Mar 2026; primary completion for Jun 2027, 15 months later.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 15 months is close to that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →