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

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Mental Distress; Insomnia

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT07230899

20250818-002-000

Details and patient eligibility

About

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.

Enrollment: 770 estimated patients

Sex: All

Ages: 12 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

770 participants in 2 patient groups

CBTi Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia

Waitlist Control

No Intervention group

Description:

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