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

Sponsor
The University of Hong Kong
Study ID
NCT07230899
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy for Insomnia — BEHAVIORAL
    Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.

Study Details

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 Dates

First listed
Nov 17, 2025
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: CBTi Intervention
    The CBTi program, designed to improve youths' sleep quality, comprises six sessions scheduled to be delivered over a six-week period. The intervention will be conducted in a small-group format (4 or above participants per group). Each session is one hour long and is led by a trained LevelMind@JC worker. All sessions will be delivered in a face-to-face format by frontline social or youth workers who have undergone training by a clinical psychologist ensuring they possess the necessary expertise to effectively implement the CBTi intervention.
  • No Intervention: Waitlist Control
    Participants allocated to the waitlist control group will wait for 10 weeks (6 + 4 weeks) before receiving the CBTi intervention

Primary Outcome Measure

Sleep Quality and Disturbance [ Time Frame: Baseline, 6-week, 10-week ]

Central Contacts

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