Mental StressNCT06868303
The Effectiveness of Mental Wellness Youth Hubs in Hong Kong
A study testing LevelMind@JC Mental Wellness Youth Hubs, New Life Psychiatric Rehabilitation Association electronic clinic for psychological service and Integrated Community Centres for Mental Wellness in people with Mental Stress, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study sets out to evaluate (i) whether the model in phase two can improve symptoms, quality of life, functioning, and psychological outcomes in young people utilising the hub services (n = 600) compared to those in the community controls (n = 600), (ii) the mechanisms that may drive these improvements, and (iii)… Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Stress
- What is being tested?
- LevelMind@JC Mental Wellness Youth Hubs, New Life Psychiatric Rehabilitation Association electronic clinic for psychological service and Integrated Community Centres for Mental Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 May 2025to 1 Apr 2028
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For hub user group: 12- to 24-year-old hub users who receive community-based mental wellness youth hub services for young people.
- For community control group: 12- to 24-year-old community youths who do not receive any youth services in the community.
- For eClinic user group: 12- to 24-year-old eClinic service users.
Who cannot join
- Youths with known diagnosis of psychiatric disorders (including Depression, Generalized Anxiety Disorder, Panic Disorder, Phobia, Obsessive Compulsive Disorder, Bipolar Disorder, Eating Disorder, Personality Disorder, Post-Traumatic Stress Disorder and Psychotic Disorder)
- Youths who receive psychiatric medication (including antidepressants, antipsychotics and antiepileptic drugs)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Quasi-controlled Study on the Effectiveness of Mental Wellness Youth Hubs in Hong Kong
This study sets out to evaluate (i) whether the model in phase two can improve symptoms, quality of life, functioning, and psychological outcomes in young people utilising the hub services (n = 600) compared to those in the community controls (n = 600), (ii) the mechanisms that may drive these improvements, and (iii) whether any particular subgroup(s) of youths (e.g., gender, socio-economic status, migrant status) may benefit more from this service model. The experiment group will include 600 hub users who are not currently using psychiatric medications and do not have a formal diagnosis at the time of enrolling in the hub activity. The control group will also comprise of 600 young people, recruited from a community cohort managed by the research team. The community cohort is accessible via the Youth Epidemiological Study Online platform (YES online), which recruits young people aged 12 to 24 years. Only YES online participants who are not using the service of LevelMind@JC and psychiatric medications will be recruited for this study. The two groups will be matched in age, gender, and baseline distress level measured by the 6-item Kessler Psychological Distress Scale (K6). There will also be a substudy assessing the effect of four service models: NLPRA eClinic, Integrated Community Centre for Mental Wellness (ICCMW) step-up care, general practitioners, and hub casework support service on symptom-based mental health outcome, comparing a cohort of young people receiving these four services respectively. A total of 252 participants will be recrruited. Another substudy will be conducted to investigate the extent to which participation in Tier 1 activities contributes to improvements in targeted outcome areas, assessing young people (n = 675) before and after their participation of Tier 1 activities. A consecutive sampling will be used, where a subject who meets the criteria of inclusion will be selected until this required sample size is achieved.
- Conditions
- Mental Stress
- Being tested
- LevelMind@JC Mental Wellness Youth Hubs, New Life Psychiatric Rehabilitation Association electronic clinic for psychological service, Integrated Community Centres for Mental Wellness, General Practitioner, Hub Casework
- Keywords
- Youth Mental Health
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevelMind@JC Mental Wellness Youth HubsBehavioural
Mental Wellness Youth Hubs Intervention aims to set up a series of community-based hubs for young people to enhance cognitive abilities, personal strengths and overall mental well-being. Among the experimental group participants (hub users), they are further divided into three tiers according to their psychological distress level. Tier 1 are youths with mild psychological distress level, who will be invited to participate in some innovative and interesting youth projects and activities (e.g., board game and floral artistry). Tier 2 are youths who have moderate level of psychological distress, or at risk for mental illness. Trained social workers will offer them with specific interventions (e.g., CBT, sleep intervention) according to their needs. Tier 3 are youths with severe level of psychological distress who are at risk for mental disorders. Diagnostic and medical assessment services will be delivered by psychiatrist or clinical psychologists.
New Life Psychiatric Rehabilitation Association electronic clinic for psychological serviceBehavioural
The eClinic treatment spans eight to fourteen week and is designed for individuals with moderate to severe mental health issues. The service is provided in a hybrid format, incorporating an in-person initial screening using the Patient Health Questionnaire-9 and General Anxiety Disorder-7, followed by online self-learning resources and sessions with a therapist. Pre- and post-treatment assessments as well as follow-ups will be used to keep track of service users' progress.
Integrated Community Centres for Mental WellnessBehavioural
Integrated Community Centres for Mental Wellness (ICCMWs) are the main community-based mental health services in Hong Kong. However, their reach among young people is limited, as their broad target age range primarily focuses on middle-aged individuals. ICCMW offers comprehensive, district-based community support and social rehabilitation services, from early prevention to risk management, for people in mental recovery, those with suspected mental health issues, their families and carers, and residents within the service area, all accessible through a single-entry point.
General PractitionerOther
Services provided by genersl practitioner
Hub CaseworkBehavioural
Services provided during hub casework sessions
| Study group | Role | What they receive |
|---|---|---|
| Hub User Group | Experimental | This group receives community-based mental wellness youth hub services for young people to enhance personal strengths and overall mental well-being. Receives: Behavioral: LevelMind@JC Mental Wellness Youth Hubs |
| Non-hub User Community Control Group | No intervention | This group does not receive any youth services in the community. |
| eClinic User Group | Active comparator | This group receives the eClinic service provided by New Life Psychiatric Rehabilitation Association. Receives: Behavioral: New Life Psychiatric Rehabilitation Association electronic clinic for psychological service |
| ICCMW group | Active comparator | This group receives the eClinic service provided by Integrated Community Centre for Mental Wellness (ICCMW) step-up care. Receives: Behavioral: Integrated Community Centres for Mental Wellness |
| GP group | Active comparator | This group receives services provided by general practitioners. Receives: Other: General Practitioner |
| Hub Casework grpup | Active comparator | This group receives services from hub casework support, as well as from NLPRA eClinic, ICCMW, and general practitioners. Receives: Behavioral: New Life Psychiatric Rehabilitation Association electronic clinic for psychological service; Behavioral: Integrated Community Centres for Mental Wellness; Other: General Practitioner; Behavioral: Hub Casework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 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, 3-month, 6-month, and 12-month
Change in Well-being
The World Health Organization-Five Well-Being Index (scores range from 0 to 25 where a higher score indicates a better outcome)
Measured: Baseline, 3-month, 6-month, and 12-month
Change in 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, 3-month, 6-month, and 12-month
Secondary outcomes (8)
Change in Depressive, Anxiety, and Stress Levels
The 21-item Depression Anxiety Stress Scales (scores range from 0 to 63 where a higher score indicates a worse outcome)
Measured: Baseline, 3-month, 6-month, and 12-month
Change in 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, 3-month, 6-month, and 12-month
Change in Sleep Quality
Pittsburgh Sleep Quality Index (scores range from 0 to 21 where a higher score indicates a worse outcome)
Measured: Baseline, 3-month, 6-month, and 12-month
Change in Physical Exercise
The International Physical Activity Questionnaire (classify physical activity level into three categories: low, moderate, and high)
Measured: Baseline, 3-month, 6-month, and 12-month
Change in Self-Esteem Level
Rosenberg Self-Esteem Scale (scores range from 0 to 30 where a higher score indicates a better outcome)
Measured: Baseline, 3-month, 6-month, and 12-month
Change in Psychological Resilience
The 10-item Connor-Davidson Resilience Scale (scores range from 0 to 40 where a higher score indicates a better outcome)
Measured: Baseline, 3-month, 6-month, and 12-month
Change in Cognitive Function
Digit Span Test
Measured: Baseline, 3-month, 6-month, and 12-month
Change in Health Economics
Client Service Receipt Inventory
Measured: Baseline, 3-month, 6-month, and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start6 May 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The experiment group will include 600 hub users who are not currently using psychiatric medications and do not have a formal diagnosis at the time of enrolling in the hub activity. The control group will also comprise of 600 young people, recruited from a community cohort managed by the research team. For the substudy examining the impact of the service model, a total of 252 participants will be recruited, with 63 individuals selected from each of the following groups: those receiving services through NLPRA eClinic, accessing care via the Integrated Community Centre for Mental Wellness (ICCMW) step-up program, managed by general practitioners, and isupported by hub casework services. For the substudy evaluating the impact pf Tier 1 activities, young people experiencing Tier 1 distress levels (determined by K6 \< 11), who have participated only in Tier 1 activities, will be recruited.
- Masking
- None (open label)
- Enrolment
- 1,300 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, Chinese YMCA of Hong Kong, New Life Psychiatric Rehabilitation Association, 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
- 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
- NCT06868303
- Sponsor's protocol ID
- 20250221-005-000
- Status last verified
- Jun 2025
- First submitted
- 7 Mar 2025
- Last updated
- 6 Jun 2025
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quasi-controlled Study on the Effectiveness of Mental Wellness Youth Hubs in Hong Kong
- ClinicalTrials.gov ID
- NCT06868303
- Acronym / sponsor ID
- 20250221-005-000
- Conditions
- Mental Stress
- Keywords
- Youth Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 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, Chinese YMCA of Hong Kong, New Life Psychiatric Rehabilitation Association, 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
- Study start
- 6 May 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 10 Mar 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 study sets out to evaluate (i) whether the model in phase two can improve symptoms, quality of life, functioning, and psychological outcomes in young people utilising the hub services (n = 600) compared to those in the community controls (n = 600), (ii) the mechanisms that may drive these improvements, and (iii) whether any particular subgroup(s) of youths (e.g., gender, socio-economic status, migrant status) may benefit more from this service model. The experiment group will include 600 hub users who are not currently using psychiatric medications and do not have a formal diagnosis at the time of enrolling in the hub activity. The control group will also comprise of 600 young people, recruited from a community cohort managed by the research team. The community cohort is accessible via the Youth Epidemiological Study Online platform (YES online), which recruits young people aged 12 to 24 years. Only YES online participants who are not using the service of LevelMind@JC and psychiatric medications will be recruited for this study. The two groups will be matched in age, gender, and baseline distress level measured by the 6-item Kessler Psychological Distress Scale (K6). There will also be a substudy assessing the effect of four service models: NLPRA eClinic, Integrated Community Centre for Mental Wellness (ICCMW) step-up care, general practitioners, and hub casework support service on symptom-based mental health outcome, comparing a cohort of young people receiving these four services respectively. A total of 252 participants will be recrruited. Another substudy will be conducted to investigate the extent to which participation in Tier 1 activities contributes to improvements in targeted outcome areas, assessing young people (n = 675) before and after their participation of Tier 1 activities. A consecutive sampling will be used, where a subject who meets the criteria of inclusion will be selected until this required sample size is achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The experiment group will include 600 hub users who are not currently using psychiatric medications and do not have a formal diagnosis at the time of enrolling in the hub activity. The control group will also comprise of 600 young people, recruited from a community cohort managed by the research team. For the substudy examining the impact of the service model, a total of 252 participants will be recruited, with 63 individuals selected from each of the following groups: those receiving services through NLPRA eClinic, accessing care via the Integrated Community Centre for Mental Wellness (ICCMW) step-up program, managed by general practitioners, and isupported by hub casework services. For the substudy evaluating the impact pf Tier 1 activities, young people experiencing Tier 1 distress levels (determined by K6 < 11), who have participated only in Tier 1 activities, will be recruited.
| Arm | Type | Receives |
|---|---|---|
| Hub User Group | Experimental | Behavioral: LevelMind@JC Mental Wellness Youth HubsThis group receives community-based mental wellness youth hub services for young people to enhance personal strengths and overall mental well-being. |
| Non-hub User Community Control Group | No intervention | –This group does not receive any youth services in the community. |
| eClinic User Group | Active comparator | Behavioral: New Life Psychiatric Rehabilitation Association electronic clinic for psychological serviceThis group receives the eClinic service provided by New Life Psychiatric Rehabilitation Association. |
| ICCMW group | Active comparator | Behavioral: Integrated Community Centres for Mental WellnessThis group receives the eClinic service provided by Integrated Community Centre for Mental Wellness (ICCMW) step-up care. |
| GP group | Active comparator | Other: General PractitionerThis group receives services provided by general practitioners. |
| Hub Casework grpup | Active comparator | Behavioral: New Life Psychiatric Rehabilitation Association electronic clinic for psychological service, Behavioral: Integrated Community Centres for Mental Wellness, Other: General Practitioner, Behavioral: Hub CaseworkThis group receives services from hub casework support, as well as from NLPRA eClinic, ICCMW, and general practitioners. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- For hub user group: 12- to 24-year-old hub users who receive community-based mental wellness youth hub services for young people.
- For community control group: 12- to 24-year-old community youths who do not receive any youth services in the community.
- For eClinic user group: 12- to 24-year-old eClinic service users.
Key exclusion criteria (2 listed)
- Youths with known diagnosis of psychiatric disorders (including Depression, Generalized Anxiety Disorder, Panic Disorder, Phobia, Obsessive Compulsive Disorder, Bipolar Disorder, Eating Disorder, Personality Disorder, Post-Traumatic Stress Disorder and Psychotic Disorder)
- Youths who receive psychiatric medication (including antidepressants, antipsychotics and antiepileptic drugs)
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 |
|---|---|---|
| LevelMind@JC Mental Wellness Youth HubsMental Wellness Youth Hubs Intervention aims to set up a series of community-based hubs for young people to enhance cognitive abilities, personal strengths and overall mental well-being. Among the experimental group participants (hub users), they are further divided into three tiers according to their psychological distress level. Tier 1 are youths with mild psychological distress level, who will be invited to participate in some innovative and interesting youth projects and activities (e.g., board game and floral artistry). Tier 2 are youths who have moderate level of psychological distress, or at risk for mental illness. Trained social workers will offer them with specific interventions (e.g., CBT, sleep intervention) according to their needs. Tier 3 are youths with severe level of psychological distress who are at risk for mental disorders. Diagnostic and medical assessment services will be delivered by psychiatrist or clinical psychologists. | Behavioural | Hub User Group |
| New Life Psychiatric Rehabilitation Association electronic clinic for psychological serviceThe eClinic treatment spans eight to fourteen week and is designed for individuals with moderate to severe mental health issues. The service is provided in a hybrid format, incorporating an in-person initial screening using the Patient Health Questionnaire-9 and General Anxiety Disorder-7, followed by online self-learning resources and sessions with a therapist. Pre- and post-treatment assessments as well as follow-ups will be used to keep track of service users' progress. | Behavioural | Hub Casework grpup, eClinic User Group |
| Integrated Community Centres for Mental WellnessIntegrated Community Centres for Mental Wellness (ICCMWs) are the main community-based mental health services in Hong Kong. However, their reach among young people is limited, as their broad target age range primarily focuses on middle-aged individuals. ICCMW offers comprehensive, district-based community support and social rehabilitation services, from early prevention to risk management, for people in mental recovery, those with suspected mental health issues, their families and carers, and residents within the service area, all accessible through a single-entry point. | Behavioural | Hub Casework grpup, ICCMW group |
| General PractitionerServices provided by genersl practitioner | Other | GP group, Hub Casework grpup |
| Hub CaseworkServices provided during hub casework sessions | Behavioural | Hub Casework grpup |
Primary outcome
Change in Psychological Distress
Time frame: Baseline, 3-month, 6-month, and 12-month
The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome)
Change in Well-being
Time frame: Baseline, 3-month, 6-month, and 12-month
The World Health Organization-Five Well-Being Index (scores range from 0 to 25 where a higher score indicates a better outcome)
Change in Quality of Life
Time frame: Baseline, 3-month, 6-month, and 12-month
The 12-item Short-Form 12 Health Survey (scores range from 0 to 100 where a higher score indicates a better outcome)
8 secondary outcomes
Change in Depressive, Anxiety, and Stress Levels
Time frame: Baseline, 3-month, 6-month, and 12-month
Change in Social and Occupational Functioning
Time frame: Baseline, 3-month, 6-month, and 12-month
Change in Sleep Quality
Time frame: Baseline, 3-month, 6-month, and 12-month
Change in Physical Exercise
Time frame: Baseline, 3-month, 6-month, and 12-month
Change in Self-Esteem Level
Time frame: Baseline, 3-month, 6-month, and 12-month
Change in Psychological Resilience
Time frame: Baseline, 3-month, 6-month, and 12-month
Change in Cognitive Function
Time frame: Baseline, 3-month, 6-month, and 12-month
Change in Health Economics
Time frame: Baseline, 3-month, 6-month, and 12-month
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 6 Jun 2025.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LevelMind@JC Mental Wellness Youth Hubs, New Life Psychiatric Rehabilitation Association electronic clinic for psychological service and Integrated Community Centres for Mental Wellness in people with Mental Stress, run by The University of Hong Kong at 1 site in 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Psychological Distress (time frame: Baseline, 3-month, 6-month, and 12-month). The study lists 3 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 6 Jun 2025.