Clinical trial NCT05078424: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Anxiety Symptoms
Keywords: Randomized Controlled Trial
Cognitive Behavioural Therapy
Youths
Depressive and Anxiety Symptoms
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
name: The Boys' and Girls' Clubs Association of Hong Kong
name: Caritas Hong Kong, Hong Kong
name: Hong Kong Federation of Youth's Group (HKFYG)
name: Hong Kong Playground Association
name: Hong Kong Children and Youth Services
name: St. James' Settlement
First posted: 2021-10-14
Enrollment: 128
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in depressive and anxiety levels
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in social anxiety levels
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in depressive levels
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in distress levels
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in depressive symptoms
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in anxiety symptoms
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in anxiety levels
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Secondary outcomes:
measure: Change in functioning
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in social and occupational functioning
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in quality of life
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in self-harm
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in resilience
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in future outlook
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in self-esteem
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
measure: Change in mindfulness
timeFrame: Baseline, after 7 weeks of intervention/wait, and 1 month after post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Psychiatry, The University of Hong Kong
Study officials:
References: