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

September 30, 2021 updated by: Professor Eric Y.H. Chen, The University of 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eric Yu Hai Chen, FHKAM (Psychiatry)
  • Phone Number: 22554486
  • Email: eyhchen@hku.hk

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Psychiatry, The University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in functioning
Time Frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Time Frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Time Frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Time Frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Time Frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Time Frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Time Frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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
Time Frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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