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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Symptoms; Anxiety Symptoms
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Yu Hai Chen, FHKAM (Psychiatry); Phone Number: 22554486; Email: eyhchen@hku.hk
• Study Contact Backup: Name: Christy Lai Ming Hui, PhD; Phone Number: 22554486; Email: christy@lmhui.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Psychiatry, The University of Hong Kong
    • Contact: Christy Lai Ming Hui, PhD; Email: christy@lmhui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT Treatment group; This group receives CBT interventions that aim to improve mental well-being, depressive and anxiety symptoms in young people.	Behavioral: Cognitive Behavioural Therapy; 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.
No Intervention: Wait-list Control group; 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?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hong Kong Jockey Club Charities Trust; The Boys' and Girls' Clubs Association of Hong Kong; Caritas Hong Kong, Hong Kong; Hong Kong Federation of Youth's Group; Hong Kong Playground Association; Hong Kong Children and Youth Services; St James' Settlement

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Cognitive Behavioural Therapy; Youths; Depressive and Anxiety Symptoms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Depression; Anxiety Disorders
• Other Study ID Numbers: LevelMind@JC CBT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No