Preventing insomnia in adults using a stepped care model
Prevention of Insomnia Using a Stepped Care Model in Adults: a Pragmatic Stepped-wedge Cluster Randomized Trial
This study is testing a new online program designed to help adults prevent insomnia by providing different levels of support based on how severe their sleep problems are.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1016 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06156293 on ClinicalTrials.gov |
What this trial studies
This study evaluates a digital platform designed to prevent insomnia in adults by employing a stepped care model tailored to the severity of insomnia symptoms. It will utilize a multicenter, assessor-blinded, pragmatic stepped-wedge cluster randomized controlled trial design across 18 districts in Hong Kong. The intervention, a cognitive behavioral prevention program for insomnia (CBP-I), will be rolled out sequentially, allowing for a comparison between districts receiving the intervention and those that do not during the control period. Participants will undergo three follow-up assessments to measure the effectiveness and long-term impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are Chinese adults aged 18-70 years with mild insomnia symptoms, as indicated by an Insomnia Severity Index score of less than 10.
Not a fit: Patients with severe mental health conditions, such as psychotic disorders or severe depression, will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of insomnia among adults, improving overall sleep quality and mental health.
How similar studies have performed: Previous studies have shown that cognitive behavioral interventions can effectively prevent insomnia in adolescents, but data in the adult population is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Department of Psychiatry, the Chinese University of Hong Kong — Hong Kong, China (Recruiting)
Study contacts
- Principal investigator: Yun Kwok Wing, FRCPsych — Department of Psychiatry, the Chinese University of Hong Kong
- Study coordinator: Rachel Ngan Yin Chan
- Email: rachel.chan@cuhk.edu.hk
- Phone: 39710550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.