Mental DisorderMBP_RCTNCT06005961
Module-Based Psychological (MBP) for Community Youths
A study testing Module-Based Psychological (MBP) Intervention in people with Mental Disorder and Depressive Symptoms, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This waitlist, randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based Psychological (MBP) intervention in reducing mental distress for youths aged 12-30 years in Hong Kong. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Mental Disorder, Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- Module-Based Psychological (MBP) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2023to 31 May 2025
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- LevelMind@JC users aged from 12-30
- Reported at-least mild mental distress
- Have sufficient proficiency in Chinese to understand verbal instructions
- Able to give informed consent
Who cannot join
- Known diagnosis of intellectual disability
- Known diagnosis of organic brain disorder
- Known psychiatric diagnosis within two years
- Current substance abuse
- Receiving any psychiatric treatments or structural psychological therapies such as cognitive behavioural therapy, mentalisation-based therapy and low-intensity online intervention, narrative therapy, mindfulness, and art-informed therapy
- Current or active suicidal ideation or attempts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Module-Based Psychological (MBP) Intervention for Young People with Mental Distress in Hong Kong
This waitlist, randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based Psychological (MBP) intervention in reducing mental distress for youths aged 12-30 years in Hong Kong. The participants randomised to the MBP group will receive 4-7 sessions of MBP (in 6 to 10 weeks) in an individual format delivered by frontline social or youth workers trained by professional clinicians. The waitlist control group will receive the same intervention after 6 weeks of waiting plus a 1-month follow-up period. The MBP is designed to improve the youths' abilities/skills in handling moods for better emotional management. Written informed consent will be signed by participants or their parents/guardians if they are under the age of 18.
Read the detailed description
This randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based Psychological (MBP) intervention in reducing mental distress for youths in Hong Kong. This intervention study will be delivered in an individual format for 4 sessions of core module in 6 weeks plus/minus 2-3 sessions of tailored-made module in 3-4 weeks by frontline social or youth workers trained by professional clinicians. It is designed to improve the youths' abilities and skills in handling moods for better emotional management. The MBP intervention has two modules: core and tailor-made modules. The core module focuses on emotional management, while the five tailor-made modules include anxiety management, mood and depression management, anger management, sleeping well, and managing self-expectation and compassion. The tailor-made modules will be assigned to youths according to their needs. While the clinical outcome of the MBP is evaluated, its cost-effectiveness is also of particular concern. Planned interim analyses are built into the project 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 to modify the conduct of the study. It is hypothesised that the youths who have received MBP intervention will demonstrate a greater reduction in mental distress, depressive symptoms, and anxiety symptoms compared to the youths in the waitlist control group. Besides, the MBP intervention will be more cost-effective than waiting.
- Conditions
- Mental Disorder, Depressive Symptoms, Anxiety Symptoms
- Being tested
- Module-Based Psychological (MBP) Intervention
- Keywords
- randomised controlled trial, module-based psychological intervention, youths, mental distress
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Module-Based Psychological (MBP) InterventionBehavioural
Participants will receive one core module related to emotional management and maximum two tailor-made modules according to the participant's needs. Each weekly session lasts for 1 hours. The core module will last for 6 weeks and the tailor-made modules will last for 3 - 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MBP intervention arm | Active comparator | The MBP intervention has two modules: the core and the tailor-made modules. The core module focuses on emotional management, while the five tailor-made modules include anxiety management, mood and depression management, anger management, sleeping well, and managing self-expectation and compassion. Receives: Behavioral: Module-Based Psychological (MBP) Intervention |
| Waitlist control arm | Other | Participants allocated to the waitlist control group will wait for 6 plus 4 weeks before receiving the MBP intervention. Receives: Behavioral: Module-Based Psychological (MBP) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
General mental distress
Measured using the Kessler Psychological Distress Scale, 6-item version (K6). The total K6 score ranges from 0 to 24, with higher scores indicating a greater distress level.
Measured: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Depressive symptoms
Measured using the 7-item Depression Subscale of the Depression, Anxiety, and Stress Scale, 21-item version (DASS-D).
The total score ranges from 0-42, with higher scores indicating greater severity of depressive symptoms.
Measured: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Anxiety symptoms
Measured using the 7-item Anxiety Subscale of the Depression Anxiety and Stress Scale 21-item version (DASS-A) The total score ranges from 0-42, with higher scores indicating greater severity of anxiety symptoms.
Measured: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Functioning
Measured using the Social and Occupational Functioning Assessment Scale (SOFAS).
The score ranges from 0-100, with higher scores indicating better social and occupational functioning related to physical and mental health.
Measured: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Secondary outcomes (3)
Health-related quality of life
Measured using the 12-Item Short Form Health Survey (SF-12). The derived index score ranges from 0-100, with higher scores indicating better physical and mental health functioning.
Measured: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Self-compassion
Measured using the 12-item Self-Compassion Scale (SCS). The total score ranges from 5-60, with higher scores indicating better self-compassion.
Measured: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Self-efficacy
Measured using the 10-item General Self-Efficacy Scale (GSE). The total score ranges from 10 and 40, with higher scores indicating more self-efficacy.
Measured: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Oct 2023
- Primary completion31 Jan 2025
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies 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
- 400 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
- Responsible party
- Principal investigator, Dr. Christy Lai-ming Hui, The University of Hong Kong
- Investigators
- Christy Lai-ming Hui, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005961
- Sponsor's protocol ID
- MBP_intervention
- Acronym
- MBP_RCT
- Status last verified
- Mar 2025
- First submitted
- 11 Aug 2023
- Last updated
- 14 Mar 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Module-Based Psychological (MBP) Intervention for Young People with Mental Distress in Hong Kong
- ClinicalTrials.gov ID
- NCT06005961
- Acronym / sponsor ID
- MBP_RCT / MBP_intervention
- Conditions
- Mental Disorder, Depressive Symptoms, Anxiety Symptoms
- Keywords
- randomised controlled trial, module-based psychological intervention, youths, mental distress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 23 Aug 2023 (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 waitlist, randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based Psychological (MBP) intervention in reducing mental distress for youths aged 12-30 years in Hong Kong. The participants randomised to the MBP group will receive 4-7 sessions of MBP (in 6 to 10 weeks) in an individual format delivered by frontline social or youth workers trained by professional clinicians. The waitlist control group will receive the same intervention after 6 weeks of waiting plus a 1-month follow-up period. The MBP is designed to improve the youths' abilities/skills in handling moods for better emotional management. Written informed consent will be signed by participants or their parents/guardians if they are under the age of 18.
Detailed description
This randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based Psychological (MBP) intervention in reducing mental distress for youths in Hong Kong. This intervention study will be delivered in an individual format for 4 sessions of core module in 6 weeks plus/minus 2-3 sessions of tailored-made module in 3-4 weeks by frontline social or youth workers trained by professional clinicians. It is designed to improve the youths' abilities and skills in handling moods for better emotional management. The MBP intervention has two modules: core and tailor-made modules. The core module focuses on emotional management, while the five tailor-made modules include anxiety management, mood and depression management, anger management, sleeping well, and managing self-expectation and compassion. The tailor-made modules will be assigned to youths according to their needs. While the clinical outcome of the MBP is evaluated, its cost-effectiveness is also of particular concern. Planned interim analyses are built into the project 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 to modify the conduct of the study. It is hypothesised that the youths who have received MBP intervention will demonstrate a greater reduction in mental distress, depressive symptoms, and anxiety symptoms compared to the youths in the waitlist control group. Besides, the MBP intervention will be more cost-effective than waiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBP intervention arm | Active comparator | Behavioral: Module-Based Psychological (MBP) InterventionThe MBP intervention has two modules: the core and the tailor-made modules. The core module focuses on emotional management, while the five tailor-made modules include anxiety management, mood and depression management, anger management, sleeping well, and managing self-expectation and compassion. |
| Waitlist control arm | Other | Behavioral: Module-Based Psychological (MBP) InterventionParticipants allocated to the waitlist control group will wait for 6 plus 4 weeks before receiving the MBP intervention. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- LevelMind@JC users aged from 12-30
- Reported at-least mild mental distress
- Have sufficient proficiency in Chinese to understand verbal instructions
- Able to give informed consent
Key exclusion criteria (6 listed)
- Known diagnosis of intellectual disability
- Known diagnosis of organic brain disorder
- Known psychiatric diagnosis within two years
- Current substance abuse
- Receiving any psychiatric treatments or structural psychological therapies such as cognitive behavioural therapy, mentalisation-based therapy and low-intensity online intervention, narrative therapy, mindfulness, and art-informed therapy
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 |
|---|---|---|
| Module-Based Psychological (MBP) InterventionParticipants will receive one core module related to emotional management and maximum two tailor-made modules according to the participant's needs. Each weekly session lasts for 1 hours. The core module will last for 6 weeks and the tailor-made modules will last for 3 - 4 weeks. | Behavioural | MBP intervention arm, Waitlist control arm |
Primary outcome
General mental distress
Time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Measured using the Kessler Psychological Distress Scale, 6-item version (K6). The total K6 score ranges from 0 to 24, with higher scores indicating a greater distress level.
Depressive symptoms
Time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Measured using the 7-item Depression Subscale of the Depression, Anxiety, and Stress Scale, 21-item version (DASS-D). The total score ranges from 0-42, with higher scores indicating greater severity of depressive symptoms.
Anxiety symptoms
Time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Measured using the 7-item Anxiety Subscale of the Depression Anxiety and Stress Scale 21-item version (DASS-A) The total score ranges from 0-42, with higher scores indicating greater severity of anxiety symptoms.
Functioning
Time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Measured using the Social and Occupational Functioning Assessment Scale (SOFAS). The score ranges from 0-100, with higher scores indicating better social and occupational functioning related to physical and mental health.
3 secondary outcomes
Health-related quality of life
Time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Self-compassion
Time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Self-efficacy
Time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
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 14 Mar 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. This study is not recruiting at the moment.
Christy Lai-ming Hui 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 Module-Based Psychological (MBP) Intervention in people with Mental Disorder and Depressive Symptoms, 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General mental distress (time frame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)). The study lists 4 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 14 Mar 2025.