Actively Recruiting
Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia in Adults, a Pragmatic Stepped-wedge Cluster Randomized Trial
Led by Chinese University of Hong Kong · Updated on 2025-07-10
1100
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Insomnia is a common sleep disorder affecting 10 to 40% of people in Hong Kong across different ages. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as a first treatment because it works as well as medication short-term and is more sustainable long-term. However, many people don't receive CBT-I due to limited access, few trained therapists, time demands, and geographic challenges. This trial evaluates a stepped-care model to deliver CBT-I using online self-help and guided approaches across 18 districts in Hong Kong, aiming to improve treatment availability and effectiveness in a real-world setting. The study provides CBT-I in three steps: first, a self-help digital program; second, a guided CBT-I program; and third, individualized consultations. The intervention will be introduced sequentially to districts in four steps, with some districts serving as controls before receiving the treatment. This stepped-wedge cluster randomized design compares outcomes between those who receive the stepped-care CBT-I and those who do not during the control period. Participants will be assessed at three times: after finishing the intervention (which varies from 8 to 24 weeks depending on treatment level), and at 3-month and 12-month follow-ups. The study measures insomnia severity, depression, anxiety, quality of life, medication use, sleep duration, and social functioning among other outcomes. The trial also monitors long-term effects and healthcare resource use to understand the impact and sustainability of this stepped-care CBT-I model.
CONDITIONS
Brief Title
A Stepped Care Model to Deliver CBT-I in Community
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese adults aged 18 to 70 years old
- Insomnia Severity Index score of 10 or higher
You will not qualify if you...
- Diagnosis of psychotic disorders such as bipolar disorder or schizophrenia
- Severe depression or suicidal thoughts
- Neurodegenerative diseases preventing intervention completion (e.g., dementia, Parkinson's disease)
- Unable to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 24 weeks depending on treatment level
Participants receive a stepped-care cognitive behavioral therapy for insomnia (CBT-I) intervention, which is provided in three steps: a self-help digital program, a guided program, and individualized consultation.
1 baseline visit and 3 follow-up visits
Duration - Up to 12 months
Participants are assessed at 3 months and 12 months after completing the CBT-I intervention to evaluate the long-term effects.
2 visits (in-person or remote)
Trial Site Locations
Total: 1 location
1
Department of Psychiatry, the Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Actively Recruiting
Research Team
R
Rachel Ngan Yin Chan, PhD
J
Jucheng Yu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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