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

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

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

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

Sponsors & Collaborators

• The Hong Kong Jockey Club Charities Trust

  collaborator OTHER

• The Boys' and Girls' Clubs Association of Hong Kong

  collaborator OTHER

• Caritas Medical Centre, Hong Kong

  collaborator OTHER

• Hong Kong Christian Service

  collaborator OTHER

• Neighbourhood Advice-Action Council

  collaborator OTHER

• St. James' Settlement

  collaborator OTHER

• Tung Wah Group of Hospitals

  collaborator OTHER

• Hong Kong Young Women's Christian Association

  collaborator OTHER

• Yan Oi Tong

  collaborator UNKNOWN

• The Salvation Army, Hong Kong and Macau Command

  collaborator OTHER

• Hong Kong Playground Association (HKPA)

  collaborator UNKNOWN

• Hong Kong Sheng Kung Hui Welfare Council Limited

  collaborator OTHER

• Hong Kong Children and Youth Services (HKCYS)

  collaborator UNKNOWN

• Hong Kong Federation of Youth's Group (HKFYG)

  collaborator OTHER

• Chinese Young Men's Christian Association of Hong Kong

  collaborator UNKNOWN

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Christy Lai Ming Hui, PhD · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-25

Primary Completion

2027-01-31

Completion

2027-08-31