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

NCT ID: NCT04995913

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-30

Study Completion Date

2024-03-30

Brief Summary

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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

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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.

Conditions

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Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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.

Group Type EXPERIMENTAL

Online cognitive behavioral therapy

Intervention Type OTHER

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.

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

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.

Group Type EXPERIMENTAL

Online cognitive behavioral therapy

Intervention Type OTHER

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.

Waitlist control group

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.

Group Type OTHER

Online cognitive behavioral therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Grants Council, Hong Kong

OTHER

Sponsor Role collaborator

Stockholm University

OTHER

Sponsor Role collaborator

Richmond Fellowship Hong Kong

UNKNOWN

Sponsor Role collaborator

Caritas Wellness Link - Tsuen Was

UNKNOWN

Sponsor Role collaborator

Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

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Jiayan Pan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiayan Pan, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Locations

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Jiayan Pan

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Jiayan Pan, PhD

Role: CONTACT

Facility Contacts

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Jiayan Pan, PhD

Role: primary

852-34116415

References

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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.

Reference Type DERIVED
PMID: 37707944 (View on PubMed)

Other Identifiers

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R2018-18

Identifier Type: -

Identifier Source: org_study_id

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