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

NCT07230899 | Not Yet Recruiting

• 1 other identifier: 20250818-002-000
• Study Type: interventional
• Target: 770
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mental Distress; Insomnia

Keywords

cluster randomized controlled trial; cognitive behavioural therapy for insomnia; youths; mental distress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Psychological Distress

  Baseline, 6-week, 10-week

• Depression

  Baseline, 6-week, 10-week

• Depression and Anxiety Symptoms

  Baseline, 6-week, 10-week

• Anxiety

  Baseline, 6-week, 10-week

• Social and Occupational Functioning

  Baseline, 6-week, 10-week

Study Arms (2)

CBTi Intervention

ACTIVE COMPARATOR

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

Waitlist Control

NO INTERVENTION

Participants allocated to the waitlist control group will wait for 10 weeks (6 + 4 weeks) before receiving the CBTi intervention

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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

CBTi Intervention

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• 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

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christy Lai Ming Hui, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Lai Ming Hui, PhD

CONTACT

+852 2255 4486; christy@lmhui.com

Yi Nam Suen, PhD

CONTACT

+852 3917 6612; suenyn@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: November 17, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share