Clinical trial NCT06005961: Module-Based Psychological (MBP) for Community Youths
Official title: A Randomised Controlled Trial of Module-Based Psychological (MBP) Intervention for Young People with Mental Distress in Hong Kong
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Disorder
Depressive Symptoms
Anxiety Symptoms
Keywords: randomised controlled trial
module-based psychological intervention
youths
mental distress
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
First posted: 2023-08-23
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. LevelMind@JC users aged from 12-30
2. Reported at-least mild mental distress
3. Have sufficient proficiency in Chinese to understand verbal instructions
4. Able to give informed consent

Exclusion Criteria:

1. Known diagnosis of intellectual disability
2. Known diagnosis of organic brain disorder
3. Known psychiatric diagnosis within two years
4. Current substance abuse
5. 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
6. Current or active suicidal ideation or attempts

Primary outcomes:
measure: General mental distress
timeFrame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
measure: Depressive symptoms
timeFrame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
measure: Anxiety symptoms
timeFrame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
measure: Functioning
timeFrame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Secondary outcomes:
measure: Health-related quality of life
timeFrame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
measure: Self-compassion
timeFrame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
measure: Self-efficacy
timeFrame: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Christy Lai-ming Hui
role: PRINCIPAL_INVESTIGATOR
References: