Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software (VRETORIK)

Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but because of the high financial costs and technical complexity of the past generation of VR hardware, there has been no large-scale implementation of this promising treatment. The present study will investigate whether off-the-shelf, commercial VR hardware and software can be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The study will recruit n=25+25 participants from the general public suffering from substantial speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo exposure. The waiting-list group will then receive an Internet-delivered VRET treatment program.

Study Overview

• Status: Completed
• Conditions: Anxiety; Social Phobia; Behavior Therapy
• Intervention / Treatment: Behavioral: Face-to-face Virtual Reality Exposure Therapy; Behavioral: Internet-administered Virtual Reality Exposure Therapy; Other: Waiting-list

• Study Type: Interventional
• Enrollment (Actual): 50
• 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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Substantial public speaking anxiety
• Have access to VR-compatible smartphone (including Internet)
• Can travel to Stockholm University for treatment on one occasion
• Can speak and understand sufficient Swedish

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: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: One-session VRET face-to-face; One-session Virtual Reality Exposure Therapy led by therapist (face-to-face), followed by a 4-week therapist-guided Internet-administered progressive maintenance program.	Behavioral: Face-to-face Virtual Reality Exposure Therapy; In session, systematic, hierarchical exposure to feared stimuli with therapist.
EXPERIMENTAL: Waiting-list, then Internet-administered VRET; 4-week waiting list, followed by therapist-guided, Internet-administered VRET with a 4-week progressive maintenance program.	Behavioral: Internet-administered Virtual Reality Exposure Therapy; Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program; Other: Waiting-list; Weekly assessments of public speaking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Public Speaking Anxiety Scale	Self-rating of public speaking anxiety	Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liebowitz Social Anxiety Scale Self-Report	Self-rating of general social anxiety	Change from baseline: Week 0, 5 and 21
Brief Fear of Negative Evaluation Scale	Self-rating of fear of negative evaluation	Change from baseline: Week 0, 5 and 21
Patient Health Questionnaire 9-item	Self-rating of depressive symptoms	Change from baseline: Week 0, 5 and 21
Generalized Anxiety Disorder 7-item	Self-rating of general anxiety symptoms	Change from baseline: Week 0, 5 and 21
Brunnsviken Brief Quality of life scale	Self-rating of quality of life	Change from baseline: Week 0, 5 and 21

Collaborators and Investigators

• Sponsor: Stockholm University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (ESTIMATE): December 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED