About this trial
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.
Eligibility criteria
Qualifiers
JC LevelMind @ Community users at least at risk for mild mental distress (Tier 2), with K6 scores above or equal to 11, or clinicians' endorsement after reviewing the case to have other issues/problems
Aged between 12 and 24 years
Insomnia Severity Index (ISI) score greater than 7
Sufficiently proficient in Chinese to comprehend verbal instructions
Disqualifiers
Young people with mild distress (K6 scores between 0 and 10)
Known diagnosis of intellectual disability
Organic brain disorder
Established psychiatric diagnosis
Trial design
Treatments tested in this trial
- Cognitive Behavioral Therapy for Insomnia
Treatment groups
Locations
Sponsors and collaborators
The University of Hong Kong
Lead sponsor
The Hong Kong Jockey Club Charities Trust
Collaborator
The Boys' and Girls' Clubs Association of Hong Kong
Collaborator
Caritas Medical Centre, Hong Kong
Collaborator
Hong Kong Christian Service
Collaborator
Neighbourhood Advice-Action Council
Collaborator
St. James' Settlement
Collaborator
Tung Wah Group of Hospitals
Collaborator
Hong Kong Young Women's Christian Association
Collaborator
Yan Oi Tong
Collaborator
The Salvation Army, Hong Kong and Macau Command
Collaborator
Hong Kong Playground Association (HKPA)
Collaborator
Hong Kong Sheng Kung Hui Welfare Council Limited
Collaborator
Hong Kong Children and Youth Services (HKCYS)
Collaborator
Hong Kong Federation of Youth's Group (HKFYG)
Collaborator
Chinese YMCA of Hong Kong
Collaborator