Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

A stepped care model to improve access to cognitive behavioral therapy for insomnia

Official title: Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia in Adults, a Pragmatic Stepped-wedge Cluster Randomized Trial

Run by Chinese University of Hong Kong · NCT06109363 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment1100 (estimated)
SponsorChinese University of Hong Kong
Academic / other
Locations1 site (Shatin, New Territories)
StatusRecruiting
StartedOctober 23, 2023
Main results expectedOctober 22, 2026
Study endsApril 22, 2027
Registry record updatedJune 24, 2026
Trial IDNCT06109363 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Chinese adults aged 18-70 years with an Insomnia Severity Index score of 10 or higher.

Probably not a fit

Patients with psychotic disorders, severe depression, neurodegenerative diseases, or those unable to provide consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.