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

Primary Purpose

Mental Disorder, Depressive Symptoms, Anxiety Symptoms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Module-Based Psychological (MBP) Intervention
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder focused on measuring randomised controlled trial, module-based psychological intervention, youths, mental distress

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    MBP intervention arm

    Waitlist control arm

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    August 11, 2023
    Last Updated
    September 7, 2023
    Sponsor
    The University of Hong Kong
    Collaborators
    The Hong Kong Jockey Club Charities Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06005961
    Brief Title
    Module-Based Psychological (MBP) for Community Youths
    Acronym
    MBP_RCT
    Official Title
    A Randomised Controlled Trial of Module-Based Psychological (MBP) Intervention for Young People With Mental Distress in Hong Kong
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong
    Collaborators
    The Hong Kong Jockey Club Charities Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorder, Depressive Symptoms, Anxiety Symptoms
    Keywords
    randomised controlled trial, module-based psychological intervention, youths, mental distress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MBP intervention arm
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Waitlist control arm
    Arm Type
    Other
    Arm Description
    Participants allocated to the waitlist control group will wait for 6 plus 4 weeks before receiving the MBP intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Module-Based Psychological (MBP) Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    General mental distress
    Description
    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.
    Time Frame
    baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
    Title
    Depressive symptoms
    Description
    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.
    Time Frame
    baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
    Title
    Anxiety symptoms
    Description
    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.
    Time Frame
    baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
    Title
    Functioning
    Description
    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.
    Time Frame
    baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
    Secondary Outcome Measure Information:
    Title
    Health-related quality of life
    Description
    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.
    Time Frame
    baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
    Title
    Self-compassion
    Description
    Measured using the 12-item Self-Compassion Scale (SCS). The total score ranges from 5-60, with higher scores indicating better self-compassion.
    Time Frame
    baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
    Title
    Self-efficacy
    Description
    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.
    Time Frame
    baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi-nam Suen
    Phone
    (852) 39179579
    Email
    suenyn@hku.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriel Chun-hei Lai
    Phone
    (852) 94517644
    Email
    gchlai@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christy Lai-ming Hui
    Organizational Affiliation
    The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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