| Registry | NCT07486973, acronym LayLedCBTIG |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | The University of Hong Kong (Other) |
| Conditions | Sleep Quality |
| Interventions | Lay-led CBT-I brief group, Booklet on sleep health (Behavioral) |
| Dates | start 2026-03-01 (estimated), primary completion 2027-06-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-03-23, last updated 2026-03-23 |
| Locations | 1 site in Hong Kong |
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All trials for Sleep Quality All trials of Lay-led CBT-I brief group All trials of Booklet on sleep health
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| The control group (CG) | Active comparator | Behavioral: Booklet on sleep health | 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. |
| The emotional support assistant group (ESAG) | Experimental | Behavioral: Lay-led CBT-I brief group | 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. |
Sex: All, ages: 45 Years to any
Inclusion Criteria: * Aged 45 or older * Have a PHQ-9 score between 5-9, and item 3 must be scored at 2 or higher * Experiencing existing symptoms of depression and sleep disturbance * Capable of providing informed consent for their participation in the study Exclusion Criteria: * Known history of intellectual disabilities, schizophrenia spectrum disorders, bipolar disorder, Parkinson's disease, or dementia * Assessed to be at active suicidal risk * Significant difficulties in communication
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Social Work and Social Administration, The University of Hong Kong | Hong Kong | Hong Kong |