Evaluating a Stepped Care Approach to Deliver Cognitive Behavioral Therapy for Insomnia in Adults Aged 18 to 70 in Community Settings

What this Trial Is About

Insomnia is a common sleep disorder affecting many adults in Hong Kong. Cognitive behavioral therapy for insomnia CBT-I is a recommended first-line treatment due to its lasting effects compared to medication. However, access to CBT-I is limited by availability of trained therapists, time constraints, and location. This trial evaluates a stepped-care model delivering CBT-I in a real-world setting using a pragmatic, stepped-wedge cluster randomized design across 18 districts in Hong Kong to improve accessibility and treatment effectiveness. The study provides a CBT-I intervention in three progressive steps starting with a self-help digital CBT-I program, followed by a guided CBT-I program, and finally individualized consultation. The intervention is rolled out sequentially to different districts in four steps, with districts not yet receiving the intervention serving as controls. This stepped approach aims to raise awareness of sleep health, improve sleep habits, and treat insomnia more efficiently. Participants will be assessed at three points after completing the intervention lasting 8 to 24 weeks depending on the treatment level, and at 3-month and 12-month follow-ups. Assessments include measuring insomnia severity, depression and anxiety levels, quality of life, sleep duration, medication use, and social functioning. The study also monitors long-term effects and resource use related to healthcare. Overall participation lasts through these follow-up periods to capture sustained treatment outcomes.

A Stepped Care Model to Deliver CBT-I in Community