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Virtual Reality Exposure Therapy for Public Speaking Anxiety (VRETA)

Primary Purpose

Public Speaking, Social Anxiety, Social Anxiety Disorder, Performance Only

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
In-session Virtual Reality exposure therapy
Internet-administered transition program
Sponsored by
Stockholm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Public Speaking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have substantial public speaking anxiety (PSAS >= 60)
  • Can travel to PBM clinic on one occasion and pay stipulated patient fee
  • Can speak and understand sufficient Swedish
  • Have stable access to the internet

Exclusion Criteria:

  • Deficits in sight or balance impacting the VR-experience
  • A severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar
  • Active psychopharmacological treatment, unless stable for last 3 months
  • Other ongoing psychological treatment

Sites / Locations

  • Department of Psychology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OST-VRET + in-vivo transition program

Arm Description

One-session treatment (OST) VRET on-location with clinical psychologist (3 hours), followed by a therapist-guided, four-week online program encouraging transition to real-world, in-vivo exposure exercises.

Outcomes

Primary Outcome Measures

Change from baseline: Public Speaking Anxiety Scale
Canonical total score will be used. Measure is self-rated, online. Swedish translation of the original PSAS (Bartholomay & Houlihan, 2016)

Secondary Outcome Measures

Change from baseline: Brunnsviken Brief Quality of life scale
Canonical total score will be used. Measure is self-rated, online.
Change from baseline: Liebowitz Social Anxiety Scale Self-Report
Canonical total score will be used. Measure is self-rated, online.
Change from baseline: Brief Fear of Negative Evaluation Scale
Canonical total score will be used. Measure is self-rated, online.
Change from baseline: Patient Health Questionnaire 9-item
Canonical total score will be used. Measure is self-rated, online.
Change from baseline: Generalized Anxiety Disorder 7-item
Canonical total score will be used. Measure is self-rated, online.

Full Information

First Posted
March 11, 2019
Last Updated
January 22, 2020
Sponsor
Stockholm University
Collaborators
PBM, Mimerse
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1. Study Identification

Unique Protocol Identification Number
NCT03885414
Brief Title
Virtual Reality Exposure Therapy for Public Speaking Anxiety
Acronym
VRETA
Official Title
Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockholm University
Collaborators
PBM, Mimerse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Virtual Reality exposure therapy (VRET) is an efficacious treatment for anxiety disorders but has yet to be implemented in regular care settings. This is arguably due to the limitations of the past generation of VR technology, which was expensive, inaccessible, cumbersome and hard to use. With the advent of consumer VR technology, VRET is now ready for implementation in regular care. This multiple-baseline trial will examine the effectiveness of VRET for public speaking anxiety (PSA) when delivered under real-world conditions at an ordinary, non-specialized mental health clinic, by clinical psychologist with only brief VRET training. Participants will either be self-referred specifically for this treatment, or come through ordinary clinical channels. Self-rated PSA will serve as primary outcome measure and will be measured three times prior to treatment (at screening and twice after a diagnostic screening telephone interview) , four times after onset, at the end of the treatment period, and three months after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Public Speaking, Social Anxiety, Social Anxiety Disorder, Performance Only

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multiple baseline
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OST-VRET + in-vivo transition program
Arm Type
Experimental
Arm Description
One-session treatment (OST) VRET on-location with clinical psychologist (3 hours), followed by a therapist-guided, four-week online program encouraging transition to real-world, in-vivo exposure exercises.
Intervention Type
Behavioral
Intervention Name(s)
In-session Virtual Reality exposure therapy
Other Intervention Name(s)
Virtual reality therapy, Exposure therapy, Cognitive behavioral therapy
Intervention Description
A series of exposure exercises (speech exercises) in front of a virtual audience, focusing on promoting inhibitory learning, with audio-feedback.
Intervention Type
Behavioral
Intervention Name(s)
Internet-administered transition program
Other Intervention Name(s)
Internet intervention
Intervention Description
Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.
Primary Outcome Measure Information:
Title
Change from baseline: Public Speaking Anxiety Scale
Description
Canonical total score will be used. Measure is self-rated, online. Swedish translation of the original PSAS (Bartholomay & Houlihan, 2016)
Time Frame
Change from baseline: (1) five days after interview, (2) ten days after interview, (3) 7 days post-OST, (4) 14 days post-OST (5) 21 days post-OST (6) 28 days post-OST, (7) 35 days post-OST, (8) 125 days post-PST
Secondary Outcome Measure Information:
Title
Change from baseline: Brunnsviken Brief Quality of life scale
Description
Canonical total score will be used. Measure is self-rated, online.
Time Frame
Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST
Title
Change from baseline: Liebowitz Social Anxiety Scale Self-Report
Description
Canonical total score will be used. Measure is self-rated, online.
Time Frame
Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Title
Change from baseline: Brief Fear of Negative Evaluation Scale
Description
Canonical total score will be used. Measure is self-rated, online.
Time Frame
Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Title
Change from baseline: Patient Health Questionnaire 9-item
Description
Canonical total score will be used. Measure is self-rated, online.
Time Frame
Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Title
Change from baseline: Generalized Anxiety Disorder 7-item
Description
Canonical total score will be used. Measure is self-rated, online.
Time Frame
Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have substantial public speaking anxiety (PSAS >= 60) Can travel to PBM clinic on one occasion and pay stipulated patient fee Can speak and understand sufficient Swedish Have stable access to the internet Exclusion Criteria: Deficits in sight or balance impacting the VR-experience A severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar Active psychopharmacological treatment, unless stable for last 3 months Other ongoing psychological treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Carlbring, PhD
Organizational Affiliation
Stockholm University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology
City
Stockholm
ZIP/Postal Code
10691
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymous outcome measure IPD will be made available upon request from academic researchers.
Citations:
PubMed Identifier
30054173
Citation
Lindner P, Miloff A, Fagernas S, Andersen J, Sigeman M, Andersson G, Furmark T, Carlbring P. Therapist-led and self-led one-session virtual reality exposure therapy for public speaking anxiety with consumer hardware and software: A randomized controlled trial. J Anxiety Disord. 2019 Jan;61:45-54. doi: 10.1016/j.janxdis.2018.07.003. Epub 2018 Jul 24. Erratum In: J Anxiety Disord. 2019 May;64:90.
Results Reference
background
Links:
URL
https://www.iterapi.se/sites/vreta/
Description
Study website (Swedish)

Learn more about this trial

Virtual Reality Exposure Therapy for Public Speaking Anxiety

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