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

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04995913
• Other study ID #: R2018-18
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2019
• Est. completion date: March 30, 2024

Study information

• Verified date: September 2023
• Source: Hong Kong Baptist University
• Contact: Jiayan Pan, PhD
• Phone: 34116415
• Email: jiayan[@]hkbu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Jiayan Pan	Hong Kong

Sponsors (5)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Caritas Wellness Link - Tsuen Was, Research Grants Council, Hong Kong, Richmond Fellowship Hong Kong, Stockholm University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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