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

Anxiety Clinical Trial

— VRETORIK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001154
• Other study ID #: VRetorik
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 2018

Study information

• Verified date: March 2019
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Behavior Therapy
• Phobia, Social
• Social Phobia

Intervention

Behavioral:
• Face-to-face Virtual Reality Exposure Therapy
In session, systematic, hierarchical exposure to feared stimuli with therapist.
• 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

Locations

Country	Name	City	State
Sweden	Department of Psychology	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Public Speaking Anxiety Scale	Self-rating of public speaking anxiety	Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21
Secondary	Liebowitz Social Anxiety Scale Self-Report	Self-rating of general social anxiety	Change from baseline: Week 0, 5 and 21
Secondary	Brief Fear of Negative Evaluation Scale	Self-rating of fear of negative evaluation	Change from baseline: Week 0, 5 and 21
Secondary	Patient Health Questionnaire 9-item	Self-rating of depressive symptoms	Change from baseline: Week 0, 5 and 21
Secondary	Generalized Anxiety Disorder 7-item	Self-rating of general anxiety symptoms	Change from baseline: Week 0, 5 and 21
Secondary	Brunnsviken Brief Quality of life scale	Self-rating of quality of life	Change from baseline: Week 0, 5 and 21