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

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ClinicalTrials.gov Identifier: NCT03001154
Recruitment Status : Active, not recruiting
First Posted : December 22, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, Stockholm University

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.

Condition or disease Intervention/treatment Phase
Social Phobia Anxiety Behavior Therapy Behavioral: Face-to-face Virtual Reality Exposure Therapy Behavioral: Internet-administered Virtual Reality Exposure Therapy Other: Waiting-list Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Liebowitz Social Anxiety Scale Self-Report [ Time Frame: Change from baseline: Week 0, 5 and 21 ]
    Self-rating of general social anxiety

  2. Brief Fear of Negative Evaluation Scale [ Time Frame: Change from baseline: Week 0, 5 and 21 ]
    Self-rating of fear of negative evaluation

  3. Patient Health Questionnaire 9-item [ Time Frame: Change from baseline: Week 0, 5 and 21 ]
    Self-rating of depressive symptoms

  4. Generalized Anxiety Disorder 7-item [ Time Frame: Change from baseline: Week 0, 5 and 21 ]
    Self-rating of general anxiety symptoms

  5. Brunnsviken Brief Quality of life scale [ Time Frame: Change from baseline: Week 0, 5 and 21 ]
    Self-rating of quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001154


Locations
Sweden
Department of Psychology
Stockholm, Sweden, 10691
Sponsors and Collaborators
Stockholm University

Responsible Party: Per Carlbring, Professor, Stockholm University
ClinicalTrials.gov Identifier: NCT03001154     History of Changes
Other Study ID Numbers: VRetorik
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders