- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388800
Online Cognitive Behavioral Intervention Program for Hong Kong People With Depression (CANDO)
Development of an Online Cognitive Behavioral Intervention Program to Reduce Depressive Symptoms for Hong Kong People With Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong
- Jiayan Pan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hong Kong resident
- Has mild to moderate depressive symptoms
- No suicidal risk in the past 3 months
- Receive no face-to-face counselling since program commencement
- Has access to a computer/smartphone with internet access
- Has a valid email address
Exclusion criteria:
- Has severe or no depressive symptoms
- Has suicidal risk in the past 3 months
- Currently receiving other psychological treatment
- Suffer from severe psychiatric conditions, such as bipolar disorder or schizophrenia
- Has no computer or smartphone with internet access
- Has no valid email address
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: web-based cognitive behavioral intervention
The web-based program is consisted of 8 online modules, forum, internal messaging, reminder, online assessment and online booking. Each online module contains mood check, animation briefing and debriefing, case demonstration videos, session review and exercise. Blended mode is adopted to deliver service, which includes the online program, two face-to-face session and 2 telephone follow-ups with a clinical psychologist. |
This study adopts a blended mode of service delivery, which included both online and offline intervention.
The online intervention includes 8 weekly online model, animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, reminder, online assessment, session review and online booking system.
The offline intervention includes two face-to-face sessions and two telephone follow-ups.
|
Experimental: app-based cognitive behavioral intervention
App-based cognitive behavioral intervention program The App-based program is consisted of 8 online modules, forum, internal messaging, reminder, online assessment and online booking. Each online module contains mood check, animation briefing and debriefing, case demonstration videos, session review and exercise. Blended mode is adopted to deliver service, which includes the online program, two face-to-face session and 2 telephone follow-ups with a clinical psychologist |
This study adopts a blended mode of service delivery, which included both online and offline intervention.
The online intervention includes 8 weekly online model, animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, reminder, online assessment, session review and online booking system.
The offline intervention includes two face-to-face sessions and two telephone follow-ups.
|
No Intervention: Wait-list control group
No intervention will be provided when the experimental group is receiving services, but the access to the app-based program will be delivered to the wait-list control group after the two experimental groups complete the service.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory-II (BDI-II)
Time Frame: 6 months
|
21-item rating scale for depressive symptoms
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6 months
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 6 months
|
9-item rating scale for depressive symptoms.
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Health Questionnaire-12 (GHQ-12)
Time Frame: 6 months
|
12 item rating scale for psychological distress.
|
6 months
|
Beck Anxiety Inventory (BAI)
Time Frame: 6 months
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21-item rating scale for symptoms of anxiety.
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6 months
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Chinese Automatic Thoughts Questionnaire (CATQ)
Time Frame: 6 months
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20-item rating scale for automatic thoughts.
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6 months
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Chinese Affect Scale (CAS)
Time Frame: 6 months
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20-item rating scale for positive and negative emotions of Chinese-speaking people.
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6 months
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Negative effects Questionnaire (NEQ) (administered at post-test only)
Time Frame: 6 months
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20-item rating scale for negative effects caused by psychological treatment
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6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITB/FBL/5002/18/P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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