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Social Anxiety DisorderNCT04995913

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

A study testing Online cognitive behavioral therapy in people with Social Anxiety Disorder, run by Hong Kong Baptist University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Social Anxiety Disorder
What is being tested?
Online cognitive behavioral therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteHong Kong
Study dates
30 Jun 2019to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jiayan Pan, PhD contact

34116415

jiayan@hkbu.edu.hk

Hong Kong1 site, 1 recruiting
  • Jiayan Pan

    Hong Kong

    Jiayan Pan, PhD, 852-34116415, jiayan@hkbu.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Being tested
Online cognitive behavioral therapy
Medical subject headings
Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online cognitive behavioral therapyOther

    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.

Study groups in NCT04995913
Study groupRoleWhat they receive
Computer-based (PC) online CBT program (Web version of the EASE Online Program)ExperimentalThe 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.
Receives: Other: Online cognitive behavioral therapy
Smartphone-based (App) online CBT program (App version of the EASE Online Program)ExperimentalThe 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.
Receives: Other: Online cognitive behavioral therapy
Waitlist control groupOtherThe Waitlist control group will receive the service of the Web version of the EASE Online Program after the two experimental groups completed the service.
Receives: Other: Online cognitive behavioral therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline: before the intervention program starts

  2. 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.

    Measured: post-test: 1 month upon completion of the intervention program

  3. 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.

    Measured: 3-month follow-up test: 3 months after completion of the intervention program

  4. 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.

    Measured: 6-month follow-up test: 6 months after completion of the intervention program

Secondary outcomes (24)
  1. 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

    Measured: baseline: before the intervention program starts

  2. 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

    Measured: post-test: 1 month upon completion of the intervention program

  3. 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

    Measured: 3-month follow-up test: 3 months after completion of the intervention program

  4. 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

    Measured: 6-month follow-up test: 6 months after completion of the intervention program

  5. 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

    Measured: baseline: before the intervention program starts

  6. 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

    Measured: post-test: 1 month upon completion of the intervention program

  7. 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

    Measured: 3-month follow-up test: 3 months after completion of the intervention program

  8. 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

    Measured: 6-month follow-up test: 6 months after completion of the intervention program

  9. 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

    Measured: baseline: before the intervention program starts

  10. 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

    Measured: post-test: 1 month upon completion of the intervention program

  11. 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

    Measured: 3-month follow-up test: 3 months after completion of the intervention program

  12. 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

    Measured: 6-month follow-up test: 6 months after completion of the intervention program

  13. 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.

    Measured: baseline: before the intervention program starts

  14. 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.

    Measured: post-test: 1 month upon completion of the intervention program

  15. 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.

    Measured: 3-month follow-up test: 3 months after completion of the intervention program

  16. 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.

    Measured: 6-month follow-up test: 6 months after completion of the intervention program

  17. 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.

    Measured: baseline: before the intervention program starts

  18. 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.

    Measured: post-test: 1 month upon completion of the intervention program

  19. 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.

    Measured: 3-month follow-up test: 3 months after completion of the intervention program

  20. 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.

    Measured: 6-month follow-up test: 6 months after completion of the intervention program

  21. 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.

    Measured: baseline: before the intervention program starts

  22. 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.

    Measured: post-test: 1 month upon completion of the intervention program

  23. 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.

    Measured: 3-month follow-up test: 3 months after completion of the intervention program

  24. 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.

    Measured: 6-month follow-up test: 6 months after completion of the intervention program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2021
  2. Study start30 Jun 2019
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion30 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995913
Sponsor's protocol ID
R2018-18
Status last verified
Sep 2023
First submitted
6 Aug 2021
Last updated
22 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pan JY. Internet-Based Cognitive Behavioral Therapy and Virtual Reality Exposure Therapy for Social Anxiety Disorder: Protocol for a Randomized Controlled Trial in Hong Kong. JMIR Res Protoc. 2023 Sep 14;12:e48437. doi: 10.2196/48437.

    PubMed 37707944

Questions about this trial

What is this clinical trial studying?

A study testing Online cognitive behavioral therapy in people with Social Anxiety Disorder, run by Hong Kong Baptist University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiayan Pan, PhD (34116415, jiayan@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Phobia Inventory (time frame: baseline: before the intervention program starts). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04995913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.

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