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

A Cluster Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong

This cluster randomized controlled trial (cRCT) 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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Mental Distress
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Study Type: Interventional
• Enrollment (Estimated): 770
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christy Lai Ming Hui, PhD; Phone Number: +852 2255 4486; Email: christy@lmhui.com
• Study Contact Backup: Name: Yi Nam Suen, PhD; Phone Number: +852 3917 6612; Email: suenyn@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• JC LevelMind @ Community users at risk for mental distress (Tier 2), with K6 scores ranging from 11 to 14
• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Cognitive Behavioral Therapy for Insomnia; Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.
No Intervention: Waitlist Control; Participants allocated to the waitlist control group will wait for 10 weeks (6 + 4 weeks) before receiving the CBTi intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality and Disturbance	Pittsburgh Sleep Quality Index Scale (scores range from 0 to 21 where a higher score indicate poorer sleep quality, and a score greater than 5 suggesting significant sleep difficulties)	Baseline, 6-week, 10-week
Insomnia Severity	Insomnia Severity Index Scale (scores range from 0 to 28 where a higher score indicates greater insomnia severity and a score of 7 or less suggested no clinical insomnia)	Baseline, 6-week, 10-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Distress	The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome)	Baseline, 6-week, 10-week
Depression	The 9-item Patient Health Questionnaire (scores range of 0 to 27 where a higher score indicates a worse outcome)	Baseline, 6-week, 10-week
Depression and Anxiety Symptoms	Depression Anxiety Stress Scales (scores range from 0 to 63 where a higher score indicates more severe symptoms)	Baseline, 6-week, 10-week
Anxiety	The 7-item Generalized Anxiety Stress Scale (scores range from 0 to 21 where a higher score indicates a worse outcome)	Baseline, 6-week, 10-week
Social and Occupational Functioning	Social and Occupational Functioning Assessment Scale (scores range from 0 to 100 where a higher score indicates a better outcome)	Baseline, 6-week, 10-week
Health-related Quality of Life	The 12-item Short-Form 12 Health Survey (scores range from 0 to 100 where a higher score indicates a better outcome)	Baseline, 6-week, 10-week
Health-related Quality of Life	The Short Form 6-Dimension (scores range from 0 to 1 where a higher score indicates a better outcome)	Baseline, 6-week, 10-week

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: The Hong Kong Jockey Club Charities Trust; Hong Kong Young Women's Christian Association; Tung Wah Group of Hospitals; The Salvation Army, Hong Kong and Macau Command; Hong Kong Christian Service; Hong Kong Sheng Kung Hui Welfare Council Limited; The Boys' and Girls' Clubs Association of Hong Kong; Caritas Hong Kong, Hong Kong; Yan Oi Tong; Hong Kong Playground Association (HKPA); Hong Kong Children and Youth Services (HKCYS); Hong Kong Federation of Youth's Group (HKFYG); Chinese Young Men's Christian Association of Hong Kong; Neighbourhood Advice-Action Council; St. James' Settlement
• Investigators: Principal Investigator: Christy Lai Ming Hui, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: August 27, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: cluster randomized controlled trial; youths; cognitive behavioural therapy for insomnia; mental distress
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 20250818-002-000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No