Trials / Active Not Recruiting
Active Not RecruitingNCT06005961
Module-Based Psychological (MBP) for Community Youths
A Randomised Controlled Trial of Module-Based Psychological (MBP) Intervention for Young People with Mental Distress in Hong Kong
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- The University of Hong Kong · Academic / Other
- Sex
- All
- Age
- 12 Years – 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2025-01-31
- Completion
- 2025-05-31
- First posted
- 2023-08-23
- Last updated
- 2025-03-14
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT06005961. Inclusion in this directory is not an endorsement.