Module-Based Psychological (MBP) for Community Youths

NCT06005961 | Active Not Recruiting

• 1 other identifier: MBP_intervention
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder; Depressive Symptoms; Anxiety Symptoms

Keywords

randomised controlled trial; module-based psychological intervention; youths; mental distress

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (3)

• Health-related quality of life

  baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)

• Self-compassion

  baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)

• Self-efficacy

  baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)

Study Arms (2)

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.

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.

Behavioral: Module-Based Psychological (MBP) Intervention

Interventions

Module-Based Psychological (MBP) Intervention BEHAVIORAL

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.

MBP intervention arm; Waitlist control arm

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Jockey Club Charities Trust: collaborator

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Christy Lai-ming Hui

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 23, 2023
• Study Start: October 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: May 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)