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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05078424
Other study ID # LevelMind@JC CBT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 29, 2021
Est. completion date April 30, 2024

Study information

Verified date September 2021
Source The University of Hong Kong
Contact Eric Yu Hai Chen, FHKAM (Psychiatry)
Phone 22554486
Email eyhchen@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 24 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Hong Kong Department of Psychiatry, The University of Hong Kong Hong Kong

Sponsors (8)

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

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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