A Randomized Controlled Trial of Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong
| Registry | NCT05078424 |
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 128 (Estimated) |
| Sponsor | The University of Hong Kong (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 |
| Conditions | Depressive Symptoms, Anxiety Symptoms |
| Interventions | Cognitive Behavioural Therapy (Behavioral) |
| Dates | start 2021-09-29, primary completion 2024-04-30 (estimated), completion 2024-04-30 (estimated), first posted 2021-10-14, last updated 2021-10-14 |
| Locations | 1 site in Hong Kong |
Related Papers Related Patents Related Grants Related Experts
All trials for Depressive Symptoms All trials for Anxiety Symptoms All trials of Cognitive Behavioural Therapy
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| CBT Treatment group | Experimental | Behavioral: Cognitive Behavioural Therapy | This 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. |
- Cognitive Behavioural Therapy (Behavioral): 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.
+Outcome measures
Primary outcomes
- Change in depressive and anxiety levels [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 [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 [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 [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 [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 [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 [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
Secondary outcomes
- Change in functioning [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
- Change in social and occupational functioning [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
- Change in quality of life [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
- Change in self-harm [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)
- Change in resilience [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
- Change in future outlook [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
- Change in self-esteem [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
- Change in mindfulness [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
+Eligibility
Sex: All, ages: 12 Years to 24 Years, accepts healthy volunteers
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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Department of Psychiatry, The University of Hong Kong | Hong Kong | Hong Kong | Recruiting |