NCT04995913

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

4.8 years

First QC Date

August 6, 2021

Last Update Submit

September 20, 2023

Conditions

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (24)

  • Beck Anxiety Inventory

    baseline: before the intervention program starts

  • Beck Anxiety Inventory

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

  • Beck Anxiety Inventory

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

  • Beck Anxiety Inventory

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

  • Beck Depression Inventory

    baseline: before the intervention program starts

  • +19 more secondary outcomes

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Waitlist control group

OTHER

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

Interventions

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.

Computer-based (PC) online CBT program (Web version of the EASE Online Program)Smartphone-based (App) online CBT program (App version of the EASE Online Program)Waitlist control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiayan Pan

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Jiayan Pan, PhD

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayan Pan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 9, 2021

Study Start

June 30, 2019

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations