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

Primary Purpose

Depressive Symptoms, Anxiety Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Randomized Controlled Trial, Cognitive Behavioural Therapy, Youths, Depressive and Anxiety Symptoms

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Psychiatry, The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT Treatment group

Wait-list Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
Change in distress levels
Kessler Psychological Distress Scale (K6), scores ranging from 0-25 with higher scores representing higher distress hence worse outcome
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
Change in anxiety symptoms
Beck Anxiety Inventory (BAI), scores ranging from 0-36 with higher scores representing severe anxiety symptoms hence worse outcome
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

Secondary Outcome Measures

Change in functioning
Role Functioning Scale (RFS), scores ranging from 1-28 with higher scores representing better functioning
Change in social and occupational functioning
Social and Occupational Functioning Assessment Scale (SOFAS), scores ranging from 0-100 with higher scores representing better functioning
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
Change in self-harm
Self-harming behaviour, plans and thoughts, recording as binary response (0=No, 1=Yes)
Change in resilience
Connor-Davidson Resilience Scale (CD-RISC), scores ranging from 0-100 with higher scores indicating higher resilience
Change in future outlook
Future Outlook Inventory (FOI), scores ranging from 1-70 with higher scores indicating greater degree of future consideration
Change in self-esteem
Rosenberg Self Esteem Scale (RSE), scores ranging from 0-30 with higher scores indicating higher self-esteem
Change in mindfulness
Mindful Attention Awareness Scale (MAAS), scores ranging from 1-6 with higher scores indicating higher mindful awareness

Full Information

First Posted
September 6, 2021
Last Updated
September 30, 2021
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
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1. Study Identification

Unique Protocol Identification Number
NCT05078424
Brief Title
Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
Official Title
A Randomized Controlled Trial of Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety Symptoms
Keywords
Randomized Controlled Trial, Cognitive Behavioural Therapy, Youths, Depressive and Anxiety Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT Treatment group
Arm Type
Experimental
Arm Description
This group receives CBT interventions that aim to improve mental well-being, depressive and anxiety symptoms in young people.
Arm Title
Wait-list Control group
Arm Type
No Intervention
Arm Description
This group does not receive CBT intervention but will receive appropriate intervention after the CBT treatment group and follow-up phases complete.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depressive and anxiety levels
Description
Depression Anxiety Stress Scales (DASS), scores ranging from 0-42 for each subscale, with higher scores representing worse outcome
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in social anxiety levels
Description
Social Interaction Anxiety Scale (SIAS), scores ranging from 0-80 with higher scores representing higher levels of social anxiety hence worse outcome
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in depressive levels
Description
Patient Health Questionnaire-9 (PHQ-9), scores ranging from 0-27 with higher scores representing higher depressive levels hence worse outcome
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in distress levels
Description
Kessler Psychological Distress Scale (K6), scores ranging from 0-25 with higher scores representing higher distress hence worse outcome
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in depressive symptoms
Description
Beck Depression Inventory II (BDI-II), scores ranging from 0-63 with higher scores representing severe depressive symptoms hence worse outcome
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in anxiety symptoms
Description
Beck Anxiety Inventory (BAI), scores ranging from 0-36 with higher scores representing severe anxiety symptoms hence worse outcome
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in anxiety levels
Description
Generalized Anxiety Stress Scale-7 (GAD-7), scores ranging from 0-21 with higher scores representing higher anxiety levels hence worse outcome
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Secondary Outcome Measure Information:
Title
Change in functioning
Description
Role Functioning Scale (RFS), scores ranging from 1-28 with higher scores representing better functioning
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in social and occupational functioning
Description
Social and Occupational Functioning Assessment Scale (SOFAS), scores ranging from 0-100 with higher scores representing better functioning
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in quality of life
Description
12-item Short Form Survey (SF-12), scores ranging from 0-100 with higher scores representing better quality of life
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in self-harm
Description
Self-harming behaviour, plans and thoughts, recording as binary response (0=No, 1=Yes)
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in resilience
Description
Connor-Davidson Resilience Scale (CD-RISC), scores ranging from 0-100 with higher scores indicating higher resilience
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in future outlook
Description
Future Outlook Inventory (FOI), scores ranging from 1-70 with higher scores indicating greater degree of future consideration
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in self-esteem
Description
Rosenberg Self Esteem Scale (RSE), scores ranging from 0-30 with higher scores indicating higher self-esteem
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Title
Change in mindfulness
Description
Mindful Attention Awareness Scale (MAAS), scores ranging from 1-6 with higher scores indicating higher mindful awareness
Time Frame
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Yu Hai Chen, FHKAM (Psychiatry)
Phone
22554486
Email
eyhchen@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Christy Lai Ming Hui, PhD
Phone
22554486
Email
christy@lmhui.com
Facility Information:
Facility Name
Department of Psychiatry, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christy Lai Ming Hui, PhD
Email
christy@lmhui.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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