Virtual Reality Exposure Therapy for Public Speaking Anxiety (VRETA)

Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety; Public Speaking; Social Anxiety Disorder, Performance Only
• Intervention / Treatment: Behavioral: In-session Virtual Reality exposure therapy; Behavioral: Internet-administered transition program

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 10691
    • Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: OST-VRET + in-vivo transition program; 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.

Behavioral: In-session Virtual Reality exposure therapy; A series of exposure exercises (speech exercises) in front of a virtual audience, focusing on promoting inhibitory learning, with audio-feedback.; Other Names: Cognitive behavioral therapy; Exposure therapy; Virtual reality therapy; Behavioral: Internet-administered transition program; Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.; Other Names: Internet intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline: Brunnsviken Brief Quality of life scale	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST
Change from baseline: Liebowitz Social Anxiety Scale Self-Report	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Change from baseline: Brief Fear of Negative Evaluation Scale	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Change from baseline: Patient Health Questionnaire 9-item	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Change from baseline: Generalized Anxiety Disorder 7-item	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST

Collaborators and Investigators

• Sponsor: Stockholm University
• Collaborators: PBM; Mimerse

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study website (Swedish)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2019
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: VRETA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymous outcome measure IPD will be made available upon request from academic researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No