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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Online cognitive behavioral 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.
Other: Online cognitive behavioral 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.
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.
Other: Online cognitive behavioral 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hong Kong Baptist University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stockholm University
Research Grants Council, Hong Kong
Richmond Fellowship Hong Kong
Caritas Wellness Link - Tsuen Was

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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