Module-Based Psychological (MBP) for Community Youths

Depressive Symptoms Clinical Trial

— MBP_RCT  

Official title:

A Randomised Controlled Trial of Module-Based Psychological (MBP) Intervention for Young People With Mental Distress in Hong Kong

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06005961
• Other study ID #: MBP_intervention
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: The University of Hong Kong
• Contact: Yi-nam Suen
• Phone: (852) 39179579
• Email: suenyn[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Symptoms
• Depression
• Depressive Symptoms
• Mental Disorder
• Mental Disorders

Intervention

Behavioral:
• Module-Based Psychological (MBP) Intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	The Hong Kong Jockey Club Charities Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Primary	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.	baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Primary	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.	baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Primary	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.	baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Secondary	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.	baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Secondary	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.	baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
Secondary	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.	baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)