NCT07230899

Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong

A Cluster Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 12 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of a Cognitive Behavioral Therapy for Insomnia (CBTi) intervention in enhancing sleep quality, overall quality of life, functional ability, and reducing mental distress among at-risk youths in Hong Kong. Participants are youths with moderate mental health concerns, indicated by K6 scores ranging from 11 to 14. The study involves seven clusters, each based on community hubs, which will be randomly assigned to either the intervention group or a wait-list control group. Clusters assigned to the intervention group will receive six weekly face-to-face sessions led by trained youth workers. Control clusters will receive the same intervention after the initial follow-up period. Participants will be evaluated at baseline, post-intervention, and one-month follow-up. An interim analysis is built for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. Furthermore, a qualitative follow-up will be conducted after the trial, involving both participants and the workers delivering the CBTi intervention. This qualitative component aims to gather feedback on participants' experiences, and inform potential revisions to enhance future implementation. It is hypothesized that youths receiving the CBTi intervention will show significantly greater improvements in sleep quality, quality of life, and functioning, along with reductions in mental distress, as well as depressive and anxiety symptoms, compared to those in the wait-list control group.

Conditions

• Mental Distress
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.

Timeline

• Start date: 2025-11-25
• Primary completion: 2027-01-31
• Completion: 2027-08-31
• First posted: 2025-11-17
• Last updated: 2025-11-17