A Randomized Controlled Trial of Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in depressive levels
研究概览
简要总结
The proposed study is a randomized controlled trial (RCT) that aims to examine the effectiveness of cognitive behavioural therapy in reducing depressive and anxiety symptoms for youths in Hong Kong. It is to be carried out with 120 youths aged 12 - 24 recruited from a series of community-based LevelMind@JC hubs, funded by the Hong Kong Jockey Club Charities Trust. It is designed to improve the youths' abilities/ skills in handling moods to have better emotional management. A written informed consent will be signed by participants. Researchers will perform cognitive behavioural therapy on youths who agree to join the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LevelMind@JC users with mild to moderate distress level (n=120);
- •have sufficient proficiency in Chinese to understand verbal instructions and give informed consent;
排除标准
- •known diagnosis of intellectual disability
- •organic brain disorder
- •photosensitive epilepsy
- •significant visual, auditory or balance impairment
- •current or previous use of illicit drugs
- •known psychiatric diagnosis (stabilized diagnosis and treatment)
- •receiving any psychosocial treatment for social withdrawal such as CBT or;
- •current or active suicidal ideation or attempts.
结局指标
主要结局
Change in depressive levels
时间窗: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Patient Health Questionnaire-9 (PHQ-9), scores ranging from 0-27 with higher scores representing higher depressive levels hence worse outcome
Change in depressive and anxiety levels
时间窗: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Depression Anxiety Stress Scales (DASS), scores ranging from 0-42 for each subscale, with higher scores representing worse outcome
Change in anxiety levels
时间窗: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Generalized Anxiety Stress Scale-7 (GAD-7), scores ranging from 0-21 with higher scores representing higher anxiety levels hence worse outcome
Change in depressive symptoms
时间窗: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Beck Depression Inventory II (BDI-II), scores ranging from 0-63 with higher scores representing severe depressive symptoms hence worse outcome
Change in anxiety symptoms
时间窗: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Beck Anxiety Inventory (BAI), scores ranging from 0-36 with higher scores representing severe anxiety symptoms hence worse outcome
Change in social anxiety levels
时间窗: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Social Interaction Anxiety Scale (SIAS), scores ranging from 0-80 with higher scores representing higher levels of social anxiety hence worse outcome
Change in distress levels
时间窗: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Kessler Psychological Distress Scale (K6), scores ranging from 0-25 with higher scores representing higher distress hence worse outcome
次要结局
- Change in self-harm(Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention)
- Change in resilience(Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention)
- Change in self-esteem(Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention)
- Change in mindfulness(Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention)
- Change in functioning(Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention)
- Change in social and occupational functioning(Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention)
- Change in quality of life(Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention)
- Change in future outlook(Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention)
研究者
Professor Eric Y.H. Chen
Chair Professor
The University of Hong Kong