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

NCT05078424 | Unknown

• 1 other identifier: LevelMind@JC CBT
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety Symptoms

Keywords

Randomized Controlled Trial; Cognitive Behavioural Therapy; Youths; Depressive and Anxiety Symptoms

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• 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 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

Study Arms (2)

CBT Treatment group

EXPERIMENTAL

This group receives CBT interventions that aim to improve mental well-being, depressive and anxiety symptoms in young people.

Behavioral: Cognitive Behavioural Therapy

Wait-list Control group

NO INTERVENTION

This group does not receive CBT intervention but will receive appropriate intervention after the CBT treatment group and follow-up phases complete.

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

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.

CBT Treatment group

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• LevelMind@JC users with mild to moderate distress level (n=120);
• have sufficient proficiency in Chinese to understand verbal instructions and give informed consent;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Jockey Club Charities Trust: collaborator
• The Boys' and Girls' Clubs Association of Hong Kong: collaborator
• Caritas Medical Centre, Hong Kong: collaborator
• Hong Kong Federation of Youth's Group (HKFYG): collaborator
• Hong Kong Playground Association: collaborator
• Hong Kong Children and Youth Services: collaborator
• St. James' Settlement: collaborator

Study Sites (1)

Department of Psychiatry, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Eric Yu Hai Chen, FHKAM (Psychiatry)

CONTACT

22554486; eyhchen@hku.hk

Christy Lai Ming Hui, PhD

CONTACT

22554486; christy@lmhui.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 14, 2021
• Study Start: September 29, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: October 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)