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

Study Overview
=================
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.

Official Title
-----------------
Development and Evaluation of the Effectiveness of an Online Cognitive Behavioral Intervention Program for Hong Kong People With Social Anxiety Disorder

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Other: Online cognitive behavioral therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer-based (PC) online CBT program (Web version of the EASE Online Program)<br>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<br>* 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.<br>|
| Experimental: Smartphone-based (App) online CBT program (App version of the EASE Online Program)<br>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<br>* 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.<br>|
| Other: Waitlist control group<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline: before the intervention program starts | 
| 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. | post-test: 1 month upon completion of the intervention program | 
| 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. | 3-month follow-up test: 3 months after completion of the intervention program | 
| 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. | 6-month follow-up test: 6 months after completion of the intervention program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline: before the intervention program starts | 
| 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 | post-test: 1 month upon completion of the intervention program | 
| 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 | 3-month follow-up test: 3 months after completion of the intervention program | 
| 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 | 6-month follow-up test: 6 months after completion of the intervention program | 
| 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 | baseline: before the intervention program starts | 
| 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 | post-test: 1 month upon completion of the intervention program | 
| 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 | 3-month follow-up test: 3 months after completion of the intervention program | 
| 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 | 6-month follow-up test: 6 months after completion of the intervention program | 
| 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 | baseline: before the intervention program starts | 
| 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 | post-test: 1 month upon completion of the intervention program | 
| 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 | 3-month follow-up test: 3 months after completion of the intervention program | 
| 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 | 6-month follow-up test: 6 months after completion of the intervention program | 
| 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. | baseline: before the intervention program starts | 
| 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. | post-test: 1 month upon completion of the intervention program | 
| 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. | 3-month follow-up test: 3 months after completion of the intervention program | 
| 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. | 6-month follow-up test: 6 months after completion of the intervention program | 
| 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. | baseline: before the intervention program starts | 
| 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. | post-test: 1 month upon completion of the intervention program | 
| 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. | 3-month follow-up test: 3 months after completion of the intervention program | 
| 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. | 6-month follow-up test: 6 months after completion of the intervention program | 
| 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. | baseline: before the intervention program starts | 
| 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. | post-test: 1 month upon completion of the intervention program | 
| 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. | 3-month follow-up test: 3 months after completion of the intervention program | 
| 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. | 6-month follow-up test: 6 months after completion of the intervention program |