Module-Based Psychological (MBP) for Community Youths (MBP_RCT)

The University of Hong Kong (HKU)

Status: Active, not recruiting

Conditions: Depressive Symptoms; Anxiety Symptoms; Mental Disorder

Treatments: Behavioral: Module-Based Psychological (MBP) Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06005961

MBP_intervention

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 12 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

MBP intervention arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Module-Based Psychological (MBP) Intervention

Waitlist control arm

Other group

Description:

Participants allocated to the waitlist control group will wait for 6 plus 4 weeks before receiving the MBP intervention.

Treatment:

Behavioral: Module-Based Psychological (MBP) Intervention