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Online Cognitive Behavioral Intervention Program for Hong Kong People With Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Online cognitive behavioral therapy
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jiayan PanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Computer-based (PC) online CBT program (Web version of the EASE Online Program)

Smartphone-based (App) online CBT program (App version of the EASE Online Program)

Waitlist control group

Arm Description

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 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 Waitlist control group will receive the service of the Web version of the EASE Online Program after the two experimental groups completed the service.

Outcomes

Primary Outcome Measures

Social Phobia Inventory
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.
Social Phobia Inventory
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.
Social Phobia Inventory
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.
Social Phobia Inventory
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.

Secondary Outcome Measures

Beck Anxiety Inventory
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Beck Anxiety Inventory
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Beck Anxiety Inventory
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Beck Anxiety Inventory
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Beck Depression Inventory
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
Beck Depression Inventory
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
Beck Depression Inventory
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
Beck Depression Inventory
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
General Health Questionnaire-12
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
General Health Questionnaire-12
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
General Health Questionnaire-12
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
General Health Questionnaire-12
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Automatic Thoughts Questionnaire
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.
Automatic Thoughts Questionnaire
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.
Automatic Thoughts Questionnaire
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.
Automatic Thoughts Questionnaire
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.
WHO Quality of life Scale-BREF
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.
WHO Quality of life Scale-BREF
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.
WHO Quality of life Scale-BREF
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.
WHO Quality of life Scale-BREF
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.
Internalized Stigma of Mental Illness
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.
Internalized Stigma of Mental Illness
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.
Internalized Stigma of Mental Illness
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.
Internalized Stigma of Mental Illness
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.

Full Information

First Posted
August 6, 2021
Last Updated
September 20, 2023
Sponsor
Hong Kong Baptist University
Collaborators
Research Grants Council, Hong Kong, Stockholm University, Richmond Fellowship Hong Kong, Caritas Wellness Link - Tsuen Was
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1. Study Identification

Unique Protocol Identification Number
NCT04995913
Brief Title
Online Cognitive Behavioral Intervention Program for Hong Kong People With Social Anxiety Disorder
Official Title
Development and Evaluation of the Effectiveness of an Online Cognitive Behavioral Intervention Program for Hong Kong People With Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Research Grants Council, Hong Kong, Stockholm University, Richmond Fellowship Hong Kong, Caritas Wellness Link - Tsuen Was

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer-based (PC) online CBT program (Web version of the EASE Online Program)
Arm Type
Experimental
Arm Description
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.
Arm Title
Smartphone-based (App) online CBT program (App version of the EASE Online Program)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Online cognitive behavioral therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Phobia Inventory
Description
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.
Time Frame
baseline: before the intervention program starts
Title
Social Phobia Inventory
Description
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.
Time Frame
post-test: 1 month upon completion of the intervention program
Title
Social Phobia Inventory
Description
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.
Time Frame
3-month follow-up test: 3 months after completion of the intervention program
Title
Social Phobia Inventory
Description
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.
Time Frame
6-month follow-up test: 6 months after completion of the intervention program
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory
Description
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Time Frame
baseline: before the intervention program starts
Title
Beck Anxiety Inventory
Description
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Time Frame
post-test: 1 month upon completion of the intervention program
Title
Beck Anxiety Inventory
Description
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Time Frame
3-month follow-up test: 3 months after completion of the intervention program
Title
Beck Anxiety Inventory
Description
21-item rating scale for anxiety symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of anxiety symptoms
Time Frame
6-month follow-up test: 6 months after completion of the intervention program
Title
Beck Depression Inventory
Description
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
Time Frame
baseline: before the intervention program starts
Title
Beck Depression Inventory
Description
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
Time Frame
post-test: 1 month upon completion of the intervention program
Title
Beck Depression Inventory
Description
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
Time Frame
3-month follow-up test: 3 months after completion of the intervention program
Title
Beck Depression Inventory
Description
21-item rating scale for depressive symptoms, scale score ranges from 0-63, with a higher score indicating a higher level of depressive symptoms
Time Frame
6-month follow-up test: 6 months after completion of the intervention program
Title
General Health Questionnaire-12
Description
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Time Frame
baseline: before the intervention program starts
Title
General Health Questionnaire-12
Description
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Time Frame
post-test: 1 month upon completion of the intervention program
Title
General Health Questionnaire-12
Description
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Time Frame
3-month follow-up test: 3 months after completion of the intervention program
Title
General Health Questionnaire-12
Description
12-item rating scale for psychological distress, scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress
Time Frame
6-month follow-up test: 6 months after completion of the intervention program
Title
Automatic Thoughts Questionnaire
Description
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.
Time Frame
baseline: before the intervention program starts
Title
Automatic Thoughts Questionnaire
Description
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.
Time Frame
post-test: 1 month upon completion of the intervention program
Title
Automatic Thoughts Questionnaire
Description
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.
Time Frame
3-month follow-up test: 3 months after completion of the intervention program
Title
Automatic Thoughts Questionnaire
Description
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.
Time Frame
6-month follow-up test: 6 months after completion of the intervention program
Title
WHO Quality of life Scale-BREF
Description
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.
Time Frame
baseline: before the intervention program starts
Title
WHO Quality of life Scale-BREF
Description
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.
Time Frame
post-test: 1 month upon completion of the intervention program
Title
WHO Quality of life Scale-BREF
Description
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.
Time Frame
3-month follow-up test: 3 months after completion of the intervention program
Title
WHO Quality of life Scale-BREF
Description
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.
Time Frame
6-month follow-up test: 6 months after completion of the intervention program
Title
Internalized Stigma of Mental Illness
Description
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.
Time Frame
baseline: before the intervention program starts
Title
Internalized Stigma of Mental Illness
Description
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.
Time Frame
post-test: 1 month upon completion of the intervention program
Title
Internalized Stigma of Mental Illness
Description
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.
Time Frame
3-month follow-up test: 3 months after completion of the intervention program
Title
Internalized Stigma of Mental Illness
Description
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.
Time Frame
6-month follow-up test: 6 months after completion of the intervention program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayan Pan, PhD
Phone
34116415
Email
jiayan@hkbu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayan Pan, PhD
Organizational Affiliation
Hong Kong Baptist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiayan Pan
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayan Pan, PhD
Phone
852-34116415
Email
jiayan@hkbu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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Online Cognitive Behavioral Intervention Program for Hong Kong People With Social Anxiety Disorder

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