Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07230899

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Mental Distress Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • JC LevelMind @ Community users at least at risk for mild mental distress (Tier 2), with K6 scores above or equal to 11, or clinicians' endorsement after reviewing the case to have other issues/problems
  • 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

  • Young people with mild distress (K6 scores between 0 and 10)
  • 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

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

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

Primary outcomes

  1. Sleep Quality and Disturbance

    Time frame: Baseline, 6-week, 10-week

    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)

  2. Insomnia Severity

    Time frame: Baseline, 6-week, 10-week

    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)

Secondary outcomes

  1. Psychological Distress

    Time frame: Baseline, 6-week, 10-week

    The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome)

  2. Depression

    Time frame: Baseline, 6-week, 10-week

    The 9-item Patient Health Questionnaire (scores range of 0 to 27 where a higher score indicates a worse outcome)

  3. Depression and Anxiety Symptoms

    Time frame: Baseline, 6-week, 10-week

    Depression Anxiety Stress Scales (scores range from 0 to 63 where a higher score indicates more severe symptoms)

  4. Anxiety

    Time frame: Baseline, 6-week, 10-week

    The 7-item Generalized Anxiety Stress Scale (scores range from 0 to 21 where a higher score indicates a worse outcome)

  5. Social and Occupational Functioning

    Time frame: Baseline, 6-week, 10-week

    Social and Occupational Functioning Assessment Scale (scores range from 0 to 100 where a higher score indicates a better outcome)

  6. Health-related Quality of Life

    Time frame: Baseline, 6-week, 10-week

    The 12-item Short-Form 12 Health Survey (scores range from 0 to 100 where a higher score indicates a better outcome)

  7. Health-related Quality of Life

    Time frame: Baseline, 6-week, 10-week

    The Short Form 6-Dimension (scores range from 0 to 1 where a higher score indicates a better outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Christy Lai Ming Hui, PhD

CONTACT

[email protected]

+852 2255 4486

Yi Nam Suen, PhD

CONTACT

[email protected]

+852 3917 6612

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Caritas Medical Centre, Hong Kong
  • Chinese YMCA of Hong Kong
  • Hong Kong Children and Youth Services (HKCYS)
  • Hong Kong Christian Service
  • Hong Kong Federation of Youth's Group (HKFYG)
  • Hong Kong Playground Association (HKPA)
  • Hong Kong Sheng Kung Hui Welfare Council Limited
  • Hong Kong Young Women's Christian Association
  • Neighbourhood Advice-Action Council
  • St. James' Settlement
  • The Boys' and Girls' Clubs Association of Hong Kong
  • The Hong Kong Jockey Club Charities Trust
  • The Salvation Army, Hong Kong and Macau Command
  • Tung Wah Group of Hospitals
  • Yan Oi Tong

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.