A stepped care model to improve access to cognitive behavioral therapy for insomnia
Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia in Adults, a Pragmatic Stepped-wedge Cluster Randomized Trial
This study is testing a new way to make cognitive behavioral therapy for insomnia more accessible to people in Hong Kong to see if it helps them sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT06109363 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to enhance access to cognitive behavioral therapy for insomnia (CBT-I) through a stepped care model in Hong Kong. It will involve a multicenter, assessor-blinded, pragmatic stepped-wedge cluster randomized controlled trial across 18 districts, where the intervention will be rolled out in phases. Participants will receive follow-up assessments to evaluate the effectiveness and long-term benefits of the CBT-I intervention. The study seeks to address the barriers to accessing CBT-I, such as limited availability of trained therapists and geographical constraints.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults aged 18-70 years with an Insomnia Severity Index score of 10 or higher.
Not a fit: Patients with psychotic disorders, severe depression, neurodegenerative diseases, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve access to effective insomnia treatment for a large number of patients.
How similar studies have performed: Previous studies have shown that self-help digital CBT-I can be effective, but this stepped care model is a novel approach to enhance accessibility and adherence.
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
Shatin, New Territories
- Department of Psychiatry, the Chinese University of Hong Kong — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Yun Kwok Wing, FRCPsych — Department of Psychiatry, the Chinese University of Hong Kong
- Study coordinator: Rachel Ngan Yin Chan, PhD
- Email: rachel.chan@cuhk.edu.hk
- Phone: 39710548
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.