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

This randomized controlled trial (RCT) 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 160 participants who will be randomly assigned to either the intervention group or a wait-list control group. Participants assigned to the intervention group will receive six weekly face-to-face sessions led by trained youth workers, while those in the control group 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.

NCT Number	NCT07230899
Lead Sponsor	The University of Hong Kong Collaborators: The Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Medical Centre, Hong Kong, Hong Kong Christian Service, Neighbourhood Advice-Action Council, St. James' Settlement, Tung Wah Group of Hospitals, Hong Kong Young Women's Christian Association, Yan Oi Tong, The Salvation Army, Hong Kong and Macau Command, Hong Kong Playground Association (HKPA), Hong Kong Sheng Kung Hui Welfare Council Limited, Hong Kong Children and Youth Services, Hong Kong Federation of Youth's Group, Chinese YMCA of Hong Kong
Conditions	Mental Distress, Insomnia
Enrollment	160 participants
Start Date	2026-08-01
Primary Completion	2027-01-31 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-27