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Not yet recruiting NCT07230899

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

No phase Interventional Mental Distress Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Therapy for Insomnia.
Who it may be relevant to
Registry conditions: Mental Distress, Insomnia. Basic parameters: 12 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Sleep Quality and Disturbance [Time frame: Baseline, 6-week, 10-week]
  • Insomnia Severity [Time frame: Baseline, 6-week, 10-week]
Secondary outcome measures (7)
  • Psychological Distress [Time frame: Baseline, 6-week, 10-week]
  • Depression [Time frame: Baseline, 6-week, 10-week]
  • Depression and Anxiety Symptoms [Time frame: Baseline, 6-week, 10-week]
  • Anxiety [Time frame: Baseline, 6-week, 10-week]
  • Social and Occupational Functioning [Time frame: Baseline, 6-week, 10-week]
  • Health-related Quality of Life [Time frame: Baseline, 6-week, 10-week]
  • Health-related Quality of Life [Time frame: Baseline, 6-week, 10-week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07230899 · 20250818-002-000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗