Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong

Conditions
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Depressive Symptoms, Anxiety Symptoms

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LevelMind@JC users with mild to moderate distress level (n=120); have sufficient proficiency in Chinese to understand verbal instructions and give informed consent; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT Treatment group<br>This group receives CBT interventions that aim to improve mental well-being, depressive and anxiety symptoms in young people. | Behavioral: Cognitive Behavioural Therapy<br>* CBT is a well-established, evidence-based intervention frequently used for easing depressive and anxiety symptoms. The intervention will be delivered for 6-7 sessions, each session lasts for 1.5 hours, in the format of a group for a period of 6-7 weeks by frontline social or youth workers trained by professional CBT clinicians. Core treatment components include mood monitoring, emotion education, behavioural activation, emotion cycle/ ABC model, identification of automatic thoughts, and cognitive restructuring. It is designed to improve youths' abilities/ skills in handling their moods to have better emotional management.<br>|
| No Intervention: Wait-list Control group<br>This group does not receive CBT intervention but will receive appropriate intervention after the CBT treatment group and follow-up phases complete. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive and anxiety levels | Depression Anxiety Stress Scales (DASS), scores ranging from 0-42 for each subscale, with higher scores representing worse outcome | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in social anxiety levels | Social Interaction Anxiety Scale (SIAS), scores ranging from 0-80 with higher scores representing higher levels of social anxiety hence worse outcome | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in depressive levels | Patient Health Questionnaire-9 (PHQ-9), scores ranging from 0-27 with higher scores representing higher depressive levels hence worse outcome | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in distress levels | Kessler Psychological Distress Scale (K6), scores ranging from 0-25 with higher scores representing higher distress hence worse outcome | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in depressive symptoms | Beck Depression Inventory II (BDI-II), scores ranging from 0-63 with higher scores representing severe depressive symptoms hence worse outcome | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in anxiety symptoms | Beck Anxiety Inventory (BAI), scores ranging from 0-36 with higher scores representing severe anxiety symptoms hence worse outcome | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in anxiety levels | Generalized Anxiety Stress Scale-7 (GAD-7), scores ranging from 0-21 with higher scores representing higher anxiety levels hence worse outcome | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functioning | Role Functioning Scale (RFS), scores ranging from 1-28 with higher scores representing better functioning | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in social and occupational functioning | Social and Occupational Functioning Assessment Scale (SOFAS), scores ranging from 0-100 with higher scores representing better functioning | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in quality of life | 12-item Short Form Survey (SF-12), scores ranging from 0-100 with higher scores representing better quality of life | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in self-harm | Self-harming behaviour, plans and thoughts, recording as binary response (0=No, 1=Yes) | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in resilience | Connor-Davidson Resilience Scale (CD-RISC), scores ranging from 0-100 with higher scores indicating higher resilience | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in future outlook | Future Outlook Inventory (FOI), scores ranging from 1-70 with higher scores indicating greater degree of future consideration | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in self-esteem | Rosenberg Self Esteem Scale (RSE), scores ranging from 0-30 with higher scores indicating higher self-esteem | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 
| Change in mindfulness | Mindful Attention Awareness Scale (MAAS), scores ranging from 1-6 with higher scores indicating higher mindful awareness | Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Cognitive Behavioural Therapy, Youths, Depressive and Anxiety Symptoms