- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04389242
Online Cognitive Behavioral Intervention Program for Hong Kong University Students (REST Online)
An Evidence-based Program Evaluation of the Effectiveness of Internet-based Cognitive Behavioral Preventive Intervention in Reducing Psychological Distress for Chinese University Students in Hong Kong
Brief summary:
The objective of this study is to develop an internet-based cognitive behavioral intervention program (including an online platform and a smartphone application) for Chinese university students in Hong Kong, and examine its effectiveness in reducing psychological distress, anxiety/depression symptoms, and improving emotions and automatic thoughts. The 3-month maintenance effect will also be tested.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Jiayan Pan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chinese nationality
- Has mild to moderate level of psychological distress
- Receive no face-to-face counselling since program commencement
Exclusion Criteria:
- Has low/high level of psychological distress
- Has one or more psychosis
- Has suicidal risk in the past 3 months
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, one face-to-face session and one telephone follow-up with a certified CBT therapist. |
Different cognitive behavioral skills are introduced and practiced in a 8 weekly online program, which includes animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, online assessment and reminder.
One face-to-face session and one telephone follow-up provided by an experienced CBT therapist are also provided to clients.
|
Experimental: app-based cognitive behavioral intervention
Application-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, one face-to-face session and one telephone follow-up with a certified CBT therapist. |
Different cognitive behavioral skills are introduced and practiced in a 8 weekly online program, which includes animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, online assessment and reminder.
One face-to-face session and one telephone follow-up provided by an experienced CBT therapist are also provided to clients.
|
Other: Wait-list control group
No intervention will be provided when the experimental groups are 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.
|
Different cognitive behavioral skills are introduced and practiced in a 8 weekly online program, which includes animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, online assessment and reminder.
One face-to-face session and one telephone follow-up provided by an experienced CBT therapist are also provided to clients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Health Questionnaire-12 (GHQ-12)
Time Frame: 3 months
|
12 item rating scale for psychological distress.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory-II (BDI-II)
Time Frame: 3 months
|
21-item rating scale for depressive symptoms.
|
3 months
|
Beck Anxiety Inventory (BAI)
Time Frame: 3 months
|
21-item rating scale for cognitive and somatic symptoms of anxiety.
|
3 months
|
Chinese Automatic Thoughts Questionnaire (CATQ)
Time Frame: 3 months
|
20-item rating scale for automatic thoughts.
|
3 months
|
Chinese Affect Scale (CAS)
Time Frame: 3 months
|
20-item rating scale for affect state of Chinese-speaking people.
|
3 months
|
Electronic Learning Satisfaction Scale (ELSS) (administered at post-test only))
Time Frame: 2 months
|
17-item rating scale for satisfaction toward electronic learning
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jiayan Pan, PhD, Hong Kong Baptist University
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
Other Study ID Numbers
- 12606118
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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