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

Depressive Symptoms Clinical Trial

Official title:

A Randomized Controlled Trial of Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078424
• Other study ID #: LevelMind@JC CBT
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Symptoms
• Depression
• Depressive Symptoms

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