NCT06156293 Prevention of Insomnia Using a Stepped Care Model in Adults
| NCT ID | NCT06156293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Sleep Disturbance |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,016 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,016 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Our previous study has shown that insomnia can be prevented through a brief cognitive behavioral prevention program in adolescents. However, there is very limited data in the adult population. Current study aims to evaluate a digital sleep-focused platform which consists of different intervention plan according to user's insomnia severity level and employed a stepped care model. Thus, the effectiveness of the stepped care model will be evaluated in a real world setting using stepped wedge cluster randomized controlled design to evaluate potential preventive effect on adults who only with mild insomnia symptoms. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a equally spaced time periods. The primary aim of this study is to evaluate the effects of a stepped-care CBT-I model in improving sleep and prevent the incidence of insomnia among participants with mild insomnia.
Eligibility Criteria
Inclusion Criteria: 1. Chinese adults aged 18-70 years old, 2. The score of Insomnia Severity Index \< 10. Exclusion Criteria: 1. present with psychotic disorders such as bipolar disorder and schizophrenia, 2. present with severe depression or suicidal ideation, 3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease). 4. unable to provide consent
Contact & Investigator
Yun Kwok Wing, FRCPsych
PRINCIPAL INVESTIGATOR
Department of Psychiatry, the Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06156293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Sleep Disturbance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06156293 currently recruiting?
Yes, NCT06156293 is actively recruiting participants. Contact the research team at rachel.chan@cuhk.edu.hk for enrollment information.
Where is the NCT06156293 trial being conducted?
This trial is being conducted at Hong Kong, China.
Who is sponsoring the NCT06156293 clinical trial?
NCT06156293 is sponsored by Chinese University of Hong Kong. The principal investigator is Yun Kwok Wing, FRCPsych at Department of Psychiatry, the Chinese University of Hong Kong. The trial plans to enroll 1,016 participants.