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

Starting soon · Not applicable

Conditions studied: Mental Distress, Insomnia

In brief

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.

Key facts

Study ID

NCT07230899

Run by

The University of Hong Kong

People needed

160

Starts

2026-08-01

Expected to finish

2027-08-31

Last updated by the study team

2026-07-27

Who can join

Age: 12 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Able to provide written informed consent (parental consent for participant aged 12-17)

You may not qualify if…

• Young people with mild distress (K6 scores between 0 and 10)
• Known diagnosis of intellectual disability
• Organic brain disorder
• Established psychiatric diagnosis
• Current substance abuse
• Receiving other structured psychological therapies such as module-based psychological therapy, mentalization-based therapy, low-intensity online interventions, cognitive-behavioral therapy, narrative therapy, mindfulness, or art-informed therapy within the hub setting or any others outside the hub setting
• Presence of current or active suicidal ideation or attempts

Full record on ClinicalTrials.gov

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