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Clinical Trials/NCT03001154
NCT03001154CompletedNot Applicable

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

Stockholm University2 sites in 1 country50 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Public Speaking Anxiety Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Waiting-list (Other)

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.

Intervention: Face-to-face Virtual Reality Exposure Therapy (Behavioral)

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.

Intervention: Internet-administered Virtual Reality Exposure Therapy (Behavioral)

Outcomes

Primary Outcomes

Public Speaking Anxiety Scale

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

Self-rating of public speaking anxiety

Secondary Outcomes

  • Patient Health Questionnaire 9-item(Change from baseline: Week 0, 5 and 21)
  • 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)
  • 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)

Investigators

Sponsor
Stockholm University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Per Carlbring

Professor

Stockholm University

Study Sites (2)

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