Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong
NCT ID: NCT07230899
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
770 participants
INTERVENTIONAL
2025-11-25
2027-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Cognitive Behavioral Therapy for Insomnia
Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.
Waitlist Control
Participants allocated to the waitlist control group will wait for 10 weeks (6 + 4 weeks) before receiving the CBTi intervention
No interventions assigned to this group
Interventions
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Cognitive Behavioral Therapy for Insomnia
Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
12 Years
24 Years
ALL
No
Sponsors
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The Hong Kong Jockey Club Charities Trust
OTHER
The Boys' and Girls' Clubs Association of Hong Kong
OTHER
Caritas Hong Kong, Hong Kong
UNKNOWN
Hong Kong Christian Service
OTHER
Neighbourhood Advice-Action Council
OTHER
St. James' Settlement
OTHER
Tung Wah Group of Hospitals
OTHER
Hong Kong Young Women's Christian Association
OTHER
Yan Oi Tong
UNKNOWN
The Salvation Army, Hong Kong and Macau Command
OTHER
Hong Kong Playground Association (HKPA)
UNKNOWN
Hong Kong Sheng Kung Hui Welfare Council Limited
OTHER
Hong Kong Children and Youth Services (HKCYS)
UNKNOWN
Hong Kong Federation of Youth's Group (HKFYG)
OTHER
Chinese Young Men's Christian Association of Hong Kong
UNKNOWN
The University of Hong Kong
OTHER
Responsible Party
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Dr. Christy Lai-ming Hui
Associate Professor
Principal Investigators
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Christy Lai Ming Hui, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Central Contacts
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Other Identifiers
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20250818-002-000
Identifier Type: -
Identifier Source: org_study_id
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