Clinical trial NCT04995913: 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
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
name: Stockholm University
name: Richmond Fellowship Hong Kong
name: Caritas Wellness Link - Tsuen Was
First posted: 2021-08-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Social Phobia Inventory
timeFrame: baseline: before the intervention program starts
measure: Social Phobia Inventory
timeFrame: post-test: 1 month upon completion of the intervention program
measure: Social Phobia Inventory
timeFrame: 3-month follow-up test: 3 months after completion of the intervention program
measure: Social Phobia Inventory
timeFrame: 6-month follow-up test: 6 months after completion of the intervention program
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: baseline: before the intervention program starts
measure: Beck Anxiety Inventory
timeFrame: post-test: 1 month upon completion of the intervention program
measure: Beck Anxiety Inventory
timeFrame: 3-month follow-up test: 3 months after completion of the intervention program
measure: Beck Anxiety Inventory
timeFrame: 6-month follow-up test: 6 months after completion of the intervention program
measure: Beck Depression Inventory
timeFrame: baseline: before the intervention program starts
measure: Beck Depression Inventory
timeFrame: post-test: 1 month upon completion of the intervention program
measure: Beck Depression Inventory
timeFrame: 3-month follow-up test: 3 months after completion of the intervention program
measure: Beck Depression Inventory
timeFrame: 6-month follow-up test: 6 months after completion of the intervention program
measure: General Health Questionnaire-12
timeFrame: baseline: before the intervention program starts
measure: General Health Questionnaire-12
timeFrame: post-test: 1 month upon completion of the intervention program
measure: General Health Questionnaire-12
timeFrame: 3-month follow-up test: 3 months after completion of the intervention program
measure: General Health Questionnaire-12
timeFrame: 6-month follow-up test: 6 months after completion of the intervention program
measure: Automatic Thoughts Questionnaire
timeFrame: baseline: before the intervention program starts
measure: Automatic Thoughts Questionnaire
timeFrame: post-test: 1 month upon completion of the intervention program
measure: Automatic Thoughts Questionnaire
timeFrame: 3-month follow-up test: 3 months after completion of the intervention program
measure: Automatic Thoughts Questionnaire
timeFrame: 6-month follow-up test: 6 months after completion of the intervention program
measure: WHO Quality of life Scale-BREF
timeFrame: baseline: before the intervention program starts
measure: WHO Quality of life Scale-BREF
timeFrame: post-test: 1 month upon completion of the intervention program
measure: WHO Quality of life Scale-BREF
timeFrame: 3-month follow-up test: 3 months after completion of the intervention program
measure: WHO Quality of life Scale-BREF
timeFrame: 6-month follow-up test: 6 months after completion of the intervention program
measure: Internalized Stigma of Mental Illness
timeFrame: baseline: before the intervention program starts
measure: Internalized Stigma of Mental Illness
timeFrame: post-test: 1 month upon completion of the intervention program
measure: Internalized Stigma of Mental Illness
timeFrame: 3-month follow-up test: 3 months after completion of the intervention program
measure: Internalized Stigma of Mental Illness
timeFrame: 6-month follow-up test: 6 months after completion of the intervention program
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Jiayan Pan
Study officials:
affiliation: Hong Kong Baptist University
name: Jiayan Pan, PhD
role: PRINCIPAL_INVESTIGATOR
References: