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Clinical Trials/NCT05078424
NCT05078424
Unknown
N/A

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

The University of Hong Kong1 site in 1 country128 target enrollmentSeptember 29, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
The University of Hong Kong
Enrollment
128
Locations
1
Primary Endpoint
Change in depressive levels
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 29, 2021
End Date
April 30, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Eric Y.H. Chen

Chair Professor

The University of Hong Kong

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in depressive levels

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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