Depressive SymptomsNCT05078424
Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
A study testing Cognitive Behavioural Therapy in people with Depressive Symptoms and Anxiety Symptoms, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Sep 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- LevelMind@JC users with mild to moderate distress level (n=120);
- have sufficient proficiency in Chinese to understand verbal instructions and give informed consent;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Psychiatry, The University of Hong Kong
Hong Kong
Christy Lai Ming Hui, PhD, christy@lmhui.com
About this study
Official title: 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.
- Conditions
- Depressive Symptoms, Anxiety Symptoms
- Being tested
- Cognitive Behavioural Therapy
- Keywords
- Randomized Controlled Trial, Cognitive Behavioural Therapy, Youths, Depressive and Anxiety Symptoms
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT Treatment group | Experimental | This group receives CBT interventions that aim to improve mental well-being, depressive and anxiety symptoms in young people. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Secondary outcomes (8)
Change in functioning
Role Functioning Scale (RFS), scores ranging from 1-28 with higher scores representing better functioning
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start29 Sep 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Medical Centre, Hong Kong, Hong Kong Federation of Youth's Group, Hong Kong Playground Association, Hong Kong Children and Youth Services, St. James' Settlement
- Responsible party
- Principal investigator, Professor Eric Y.H. Chen, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078424
- Sponsor's protocol ID
- LevelMind@JC CBT
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
- ClinicalTrials.gov ID
- NCT05078424
- Acronym / sponsor ID
- LevelMind@JC CBT
- Conditions
- Depressive Symptoms, Anxiety Symptoms
- Keywords
- Randomized Controlled Trial, Cognitive Behavioural Therapy, Youths, Depressive and Anxiety Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Medical Centre, Hong Kong, Hong Kong Federation of Youth's Group, Hong Kong Playground Association, Hong Kong Children and Youth Services, St. James' Settlement
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT Treatment group | Experimental | Behavioral: Cognitive Behavioural TherapyThis group receives CBT interventions that aim to improve mental well-being, depressive and anxiety symptoms in young people. |
| 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. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- LevelMind@JC users with mild to moderate distress level (n=120);
- have sufficient proficiency in Chinese to understand verbal instructions and give informed consent;
Key exclusion criteria (8 listed)
- known diagnosis of intellectual disability
- organic brain disorder
- photosensitive epilepsy
- significant visual, auditory or balance impairment
- current or previous use of illicit drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural TherapyCBT 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. | Behavioural | CBT Treatment group |
Primary 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 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 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 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
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 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
8 secondary outcomes
Change in functioning
Time frame: 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
Change in quality of life
Time frame: 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
Change in resilience
Time frame: 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
Change in self-esteem
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Depressive Symptoms and Anxiety Symptoms, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Yu Hai Chen, FHKAM (Psychiatry) (22554486, eyhchen@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive and anxiety levels (time frame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.