A Randomised Controlled Trial of Module-Based Psychological (MBP) Intervention for Young People with Mental Distress in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- General mental distress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
General mental distress
时间窗: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
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
时间窗: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
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
时间窗: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
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
时间窗: baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2)
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.
次要结局
- Health-related quality of life(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))
- Self-compassion(baseline (T0), post-treatment (6-week, T1), and follow-up (9 week, T2))
研究者
Dr. Christy Lai-ming Hui
Associate professor
The University of Hong Kong