- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995913
Online Cognitive Behavioral Intervention Program for Hong Kong People With Social Anxiety Disorder
September 20, 2023 updated by: Jiayan Pan, Hong Kong Baptist University
Development and Evaluation of the Effectiveness of an Online Cognitive Behavioral Intervention Program for Hong Kong People With Social Anxiety Disorder
This study developed an online counseling program called "EASE Online" for Hong Kong people with social anxiety disorder.
The program effectiveness was evaluated by a randomized controlled trial in reducing social anxiety and improving quality of life of the participants.
The 3- and 6-month maintenance effects were also tested.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Social anxiety disorder (SAD), also known as social phobia, is one of the most common mental disorders worldwide.
In Hong Kong, the 12-month prevalence of SAD is 3.2% (Lee, Lee & Kwok, 2005) with more than 230,000 sufferers.
However, only 8.7% of SAD sufferers have sought medical treatment in Hong Kong (Lee et al., 2005), which means that most of the sufferers are undiagnosed and untreated.
One of the most effective treatments for SAD is cognitive behavioral therapy (CBT), and internet-based CBT has shown promise in reducing general and social anxieties, as well as improving the quality of life of those with SAD (e.g.
Carlbring et al., 2007; Tillfors et al., 2011).
However, few studies have been conducted in this field in Hong Kong.
This project aims to develop an online CBT program (including both an online platform and mobile application) for Hong Kong people with SAD, as well as evaluate its effectiveness in reducing anxiety symptoms and psychological distress, and improving quality of life at post-treatment and 3- and 6-month follow-ups.
Randomized controlled trial (RCT) design was adopted for program evaluation.
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiayan Pan, PhD
- Phone Number: 34116415
- Email: jiayan@hkbu.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Jiayan Pan
-
Contact:
- Jiayan Pan, PhD
- Phone Number: 852-34116415
- Email: jiayan@hkbu.edu.hk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Hong Kong residents with fluency in Cantonese
- between the ages of 18 and 70
- a score of 25 or more on the Chinese version of the Social Phobia Inventory (C-SPIN) (Tsai et al., 2009)
- have not received any psychological treatment at the time of registration for participation in the project
- have access to a computer or smartphone with internet connection.
Exclusion Criteria:
- being severely depressed, with a score above 30 on the Beck Depression Inventory-II (BDI-II) (Beck, Steer & Brown, 1996)
- having suicidal ideation in the past three months, with a score of 3 points on Item 9 of the BDI-II.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computer-based (PC) online CBT program (Web version of the EASE Online Program)
The Web version of the EASE Online Program delivers the online CBT program through the Program website.
It includes 9 online modules, 3 face-to-face/online/telephone counseling sessions, and 2 sessions of virtual reality exposure therapy.
|
The intervention includes 9 online modules, 3 face-to-face/online/telephone counseling sessions, and 2 sessions of virtual reality exposure therapy.
Participants will learn and practice a variety of the cognitive behavioral skills to cope with their social anxiety.
The functions of the EASE Online Program include animation briefing and debriefing, case demonstration videos, assignment and feedback, forum, internal messaging, reminder, online assessment, online booking and progress checking.
The duration of the intervention is 14 weeks.
|
Experimental: Smartphone-based (App) online CBT program (App version of the EASE Online Program)
The App version of the EASE Online Program delivers the online CBT program through a smartphone application.
The program content and system functions are the same as those of the Web version.
|
The intervention includes 9 online modules, 3 face-to-face/online/telephone counseling sessions, and 2 sessions of virtual reality exposure therapy.
Participants will learn and practice a variety of the cognitive behavioral skills to cope with their social anxiety.
The functions of the EASE Online Program include animation briefing and debriefing, case demonstration videos, assignment and feedback, forum, internal messaging, reminder, online assessment, online booking and progress checking.
The duration of the intervention is 14 weeks.
|
Other: Waitlist control group
The Waitlist control group will receive the service of the Web version of the EASE Online Program after the two experimental groups completed the service.
|
The intervention includes 9 online modules, 3 face-to-face/online/telephone counseling sessions, and 2 sessions of virtual reality exposure therapy.
Participants will learn and practice a variety of the cognitive behavioral skills to cope with their social anxiety.
The functions of the EASE Online Program include animation briefing and debriefing, case demonstration videos, assignment and feedback, forum, internal messaging, reminder, online assessment, online booking and progress checking.
The duration of the intervention is 14 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Phobia Inventory
Time Frame: baseline: before the intervention program starts
|
17-item rating scale for social anxiety symptoms, total scale score ratings from 0-68, with a higher score indicating a higher level of social anxiety.
|
baseline: before the intervention program starts
|
Social Phobia Inventory
Time Frame: post-test: 1 month upon completion of the intervention program
|
17-item rating scale for social anxiety symptoms, total scale score ratings from 0-68, with a higher score indicating a higher level of social anxiety.
|
post-test: 1 month upon completion of the intervention program
|
Social Phobia Inventory
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
|
17-item rating scale for social anxiety symptoms, total scale score ratings from 0-68, with a higher score indicating a higher level of social anxiety.
|
3-month follow-up test: 3 months after completion of the intervention program
|
Social Phobia Inventory
Time Frame: 6-month follow-up test: 6 months after completion of the intervention program
|
17-item rating scale for social anxiety symptoms, total scale score ratings from 0-68, with a higher score indicating a higher level of social anxiety.
|
6-month follow-up test: 6 months after completion of the intervention program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Health Questionnaire-12
Time Frame: baseline: before the intervention program starts
|
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
|
baseline: before the intervention program starts
|
General Health Questionnaire-12
Time Frame: post-test: 1 month upon completion of the intervention program
|
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
|
post-test: 1 month upon completion of the intervention program
|
General Health Questionnaire-12
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
|
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
|
3-month follow-up test: 3 months after completion of the intervention program
|
Beck Anxiety Inventory
Time Frame: baseline: before the intervention program starts
|
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
|
baseline: before the intervention program starts
|
Beck Anxiety Inventory
Time Frame: post-test: 1 month upon completion of the intervention program
|
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
|
post-test: 1 month upon completion of the intervention program
|
Beck Anxiety Inventory
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
|
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
|
3-month follow-up test: 3 months after completion of the intervention program
|
Beck Anxiety Inventory
Time Frame: 6-month follow-up test: 6 months after completion of the intervention program
|
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
|
6-month follow-up test: 6 months after completion of the intervention program
|
Beck Depression Inventory
Time Frame: baseline: before the intervention program starts
|
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
|
baseline: before the intervention program starts
|
Beck Depression Inventory
Time Frame: post-test: 1 month upon completion of the intervention program
|
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
|
post-test: 1 month upon completion of the intervention program
|
Beck Depression Inventory
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
|
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
|
3-month follow-up test: 3 months after completion of the intervention program
|
Beck Depression Inventory
Time Frame: 6-month follow-up test: 6 months after completion of the intervention program
|
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
|
6-month follow-up test: 6 months after completion of the intervention program
|
General Health Questionnaire-12
Time Frame: 6-month follow-up test: 6 months after completion of the intervention program
|
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
|
6-month follow-up test: 6 months after completion of the intervention program
|
Automatic Thoughts Questionnaire
Time Frame: baseline: before the intervention program starts
|
14-item rating scale for positive and negative automatic thoughts, score ranges from 1-5 for the positive thought subscale and negative thought subscale, with a higher score indicating a higher level of positive/negative thought.
|
baseline: before the intervention program starts
|
Automatic Thoughts Questionnaire
Time Frame: post-test: 1 month upon completion of the intervention program
|
14-item rating scale for positive and negative automatic thoughts, score ranges from 1-5 for the positive thought subscale and negative thought subscale, with a higher score indicating a higher level of positive/negative thought.
|
post-test: 1 month upon completion of the intervention program
|
Automatic Thoughts Questionnaire
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
|
14-item rating scale for positive and negative automatic thoughts, score ranges from 1-5 for the positive thought subscale and negative thought subscale, with a higher score indicating a higher level of positive/negative thought.
|
3-month follow-up test: 3 months after completion of the intervention program
|
Automatic Thoughts Questionnaire
Time Frame: 6-month follow-up test: 6 months after completion of the intervention program
|
14-item rating scale for positive and negative automatic thoughts, score ranges from 1-5 for the positive thought subscale and negative thought subscale, with a higher score indicating a higher level of positive/negative thought.
|
6-month follow-up test: 6 months after completion of the intervention program
|
WHO Quality of life Scale-BREF
Time Frame: baseline: before the intervention program starts
|
28-item rating scale for quality of life, including 2 items that measure the overall quality of life and 26 items that measure physical and psychological health, social relationships and the environment.
Item score ranges from 1 (very dissatisfied) to 5 (very satisfied), with a higher score indicating better quality of life.
|
baseline: before the intervention program starts
|
WHO Quality of life Scale-BREF
Time Frame: post-test: 1 month upon completion of the intervention program
|
28-item rating scale for quality of life, including 2 items that measure the overall quality of life and 26 items that measure physical and psychological health, social relationships and the environment.
Item score ranges from 1 (very dissatisfied) to 5 (very satisfied), with a higher score indicating better quality of life.
|
post-test: 1 month upon completion of the intervention program
|
WHO Quality of life Scale-BREF
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
|
28-item rating scale for quality of life, including 2 items that measure the overall quality of life and 26 items that measure physical and psychological health, social relationships and the environment.
Item score ranges from 1 (very dissatisfied) to 5 (very satisfied), with a higher score indicating better quality of life.
|
3-month follow-up test: 3 months after completion of the intervention program
|
WHO Quality of life Scale-BREF
Time Frame: 6-month follow-up test: 6 months after completion of the intervention program
|
28-item rating scale for quality of life, including 2 items that measure the overall quality of life and 26 items that measure physical and psychological health, social relationships and the environment.
Item score ranges from 1 (very dissatisfied) to 5 (very satisfied), with a higher score indicating better quality of life.
|
6-month follow-up test: 6 months after completion of the intervention program
|
Internalized Stigma of Mental Illness
Time Frame: baseline: before the intervention program starts
|
24-item rating scale for the subjective experiences of self-stigma on mental illness.
It consists of 4 subscales: shame/alienation, stereotype endorsement, perceived discrimination and social withdrawal.
Item score ranges from "1" ("strongly disagree") to "4" ("strongly agree").
All items are averaged as a scale score, with a higher score indicating a higher level of self-stigma.
|
baseline: before the intervention program starts
|
Internalized Stigma of Mental Illness
Time Frame: post-test: 1 month upon completion of the intervention program
|
24-item rating scale for the subjective experiences of self-stigma on mental illness.
It consists of 4 subscales: shame/alienation, stereotype endorsement, perceived discrimination and social withdrawal.
Item score ranges from "1" ("strongly disagree") to "4" ("strongly agree").
All items are averaged as a scale score, with a higher score indicating a higher level of self-stigma.
|
post-test: 1 month upon completion of the intervention program
|
Internalized Stigma of Mental Illness
Time Frame: 3-month follow-up test: 3 months after completion of the intervention program
|
24-item rating scale for the subjective experiences of self-stigma on mental illness.
It consists of 4 subscales: shame/alienation, stereotype endorsement, perceived discrimination and social withdrawal.
Item score ranges from "1" ("strongly disagree") to "4" ("strongly agree").
All items are averaged as a scale score, with a higher score indicating a higher level of self-stigma.
|
3-month follow-up test: 3 months after completion of the intervention program
|
Internalized Stigma of Mental Illness
Time Frame: 6-month follow-up test: 6 months after completion of the intervention program
|
24-item rating scale for the subjective experiences of self-stigma on mental illness.
It consists of 4 subscales: shame/alienation, stereotype endorsement, perceived discrimination and social withdrawal.
Item score ranges from "1" ("strongly disagree") to "4" ("strongly agree").
All items are averaged as a scale score, with a higher score indicating a higher level of self-stigma.
|
6-month follow-up test: 6 months after completion of the intervention program
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jiayan Pan, PhD, Hong Kong Baptist University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2019
Primary Completion (Estimated)
March 30, 2024
Study Completion (Estimated)
March 30, 2024
Study Registration Dates
First Submitted
August 6, 2021
First Submitted That Met QC Criteria
August 6, 2021
First Posted (Actual)
August 9, 2021
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R2018-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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