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NCT06109363
A Stepped Care Model to Deliver CBT-I in Community
NA trial testing Cognitive behavioral therapy for insomnia (CBT-I) in Insomnia in 1,100 participants. Currently enrolling.
22 January 2026
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 1,100 |
| Start date | 23 October 2023 |
| Primary completion | 22 January 2026 |
| Estimated completion | 22 April 2026 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Cognitive behavioral therapy for insomnia (CBT-I)
Conditions studied
- Insomnia — all drugs for Insomnia →
- Sleep Disturbance — all drugs for Sleep Disturbance →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 18 to 70, any sex, with Insomnia or Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due to limited accessibility, lack of trained sleep therapists, time costing and geographical limitations. To increase CBT-I accessibility, different formats of CBT-I have been proposed. Empirical evidence including ours consistently suggested that self-help digital CBT-I is effective in improving sleep while its augmentation with a guided approach could further enhance the treatment gain. Previous evidence has suggested that although self-help CBT-I could lead to positive outcomes, the drop out rate is quite high and maybe less effective for patients with comorbidity or high level of distress. Thus, a stepped-care approach to CBT-I that utilizes online self help and therapist-guided modes of delivery might be a potential way to facilitate efficient dissemination of effective insomnia treatment resources. The effectiveness of the stepped care model will be evaluated in a real world setting using stepped-wedge cluster randomized controlled design. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a eqaully spaced time periods.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06109363
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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Other recruiting trials for Insomnia
Currently open trials in the same condition.
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- NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other Chinese University of Hong Kong trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06109363 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 10 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06109363.
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