Mental DistressNCT07230899
Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong
A study testing Cognitive Behavioral Therapy for Insomnia in people with Mental Distress and Insomnia, run by The University of Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Mental Distress, Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial of 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.
Read more
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
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- cognitive behavioural therapy for insomnia, youths, mental distress, randomised controlled trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Participants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline, 6-week, 10-week
Secondary outcomes (7)
Psychological Distress
The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome)
Measured: Baseline, 6-week, 10-week
Depression
The 9-item Patient Health Questionnaire (scores range of 0 to 27 where a higher score indicates a worse outcome)
Measured: Baseline, 6-week, 10-week
Depression and Anxiety Symptoms
Depression Anxiety Stress Scales (scores range from 0 to 63 where a higher score indicates more severe symptoms)
Measured: Baseline, 6-week, 10-week
Anxiety
The 7-item Generalized Anxiety Stress Scale (scores range from 0 to 21 where a higher score indicates a worse outcome)
Measured: Baseline, 6-week, 10-week
Social and Occupational Functioning
Social and Occupational Functioning Assessment Scale (scores range from 0 to 100 where a higher score indicates a better outcome)
Measured: Baseline, 6-week, 10-week
Health-related Quality of Life
The 12-item Short-Form 12 Health Survey (scores range from 0 to 100 where a higher score indicates a better outcome)
Measured: Baseline, 6-week, 10-week
Health-related Quality of Life
The Short Form 6-Dimension (scores range from 0 to 1 where a higher score indicates a better outcome)
Measured: Baseline, 6-week, 10-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DistressStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Medical Centre, Hong Kong, Hong Kong Christian Service, Neighbourhood Advice-Action Council, St. James' Settlement, Tung Wah Group of Hospitals, Hong Kong Young Women's Christian Association, Yan Oi Tong, The Salvation Army, Hong Kong and Macau Command, Hong Kong Playground Association (HKPA), Hong Kong Sheng Kung Hui Welfare Council Limited, Hong Kong Children and Youth Services, Hong Kong Federation of Youth's Group, Chinese YMCA of Hong Kong
- Responsible party
- Principal investigator, Dr. Christy Lai-ming Hui, The University of Hong Kong
- Investigators
- Christy Lai Ming Hui, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230899
- Sponsor's protocol ID
- 20250818-002-000
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong
- ClinicalTrials.gov ID
- NCT07230899
- Acronym / sponsor ID
- 20250818-002-000
- Conditions
- Mental Distress, Insomnia
- Keywords
- cognitive behavioural therapy for insomnia, youths, mental distress, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Medical Centre, Hong Kong, Hong Kong Christian Service, Neighbourhood Advice-Action Council, St. James' Settlement, Tung Wah Group of Hospitals, Hong Kong Young Women's Christian Association, Yan Oi Tong, The Salvation Army, Hong Kong and Macau Command, Hong Kong Playground Association (HKPA), Hong Kong Sheng Kung Hui Welfare Council Limited, Hong Kong Children and Youth Services, Hong Kong Federation of Youth's Group, Chinese YMCA of Hong Kong
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBTi Intervention | Active comparator | Behavioral: Cognitive Behavioral Therapy for InsomniaThe 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. |
| Waitlist Control | No intervention | –Participants allocated to the waitlist control group will wait for 10 weeks (6 + 4 weeks) before receiving the CBTi intervention |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaParticipants will receive the Cognitive Behavioral Therapy for Insomnia designed to improve youths' sleep quality. | Behavioural | CBTi Intervention |
Primary outcome
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)
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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christy Lai Ming Hui, PhD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Mental Distress and Insomnia, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christy Lai Ming Hui, PhD (+852 2255 4486, christy@lmhui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality and Disturbance (time frame: Baseline, 6-week, 10-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.