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

NCT03001154 | Completed

• 1 other identifier: VRetorik
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Phobia; Anxiety; Behavior Therapy

Outcome Measures

Primary Outcomes (1)

• Public Speaking Anxiety Scale

  Self-rating of public speaking anxiety

  Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21

Secondary Outcomes (5)

• Liebowitz Social Anxiety Scale Self-Report

  Change from baseline: Week 0, 5 and 21

• Brief Fear of Negative Evaluation Scale

  Change from baseline: Week 0, 5 and 21

• Patient Health Questionnaire 9-item

  Change from baseline: Week 0, 5 and 21

• Generalized Anxiety Disorder 7-item

  Change from baseline: Week 0, 5 and 21

• Brunnsviken Brief Quality of life scale

  Change from baseline: Week 0, 5 and 21

Study Arms (2)

One-session VRET face-to-face

EXPERIMENTAL

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

Waiting-list, then Internet-administered VRET

EXPERIMENTAL

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; Other: Waiting-list

Interventions

Face-to-face Virtual Reality Exposure Therapy BEHAVIORAL

In session, systematic, hierarchical exposure to feared stimuli with therapist.

One-session VRET face-to-face

Internet-administered Virtual Reality Exposure Therapy BEHAVIORAL

Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program

Waiting-list, then Internet-administered VRET

Waiting-list OTHER

Weekly assessments of public speaking

Waiting-list, then Internet-administered VRET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stockholm University: lead

Study Sites (1)

Department of Psychology

Stockholm, 10691, Sweden

Location

MeSH Terms

Conditions

Phobia, Social; Anxiety Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 22, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

SE (1)