Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Preventing insomnia in adults using a stepped care model

Official title: Prevention of Insomnia Using a Stepped Care Model in Adults: a Pragmatic Stepped-wedge Cluster Randomized Trial

Run by Chinese University of Hong Kong · NCT06156293 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment1016 (estimated)
SponsorChinese University of Hong Kong
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedDecember 1, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedMarch 23, 2026
Trial IDNCT06156293 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with severe mental health conditions, such as psychotic disorders or severe depression, will 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 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.

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 gone: 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.

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
    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

Similar studies

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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.