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

Primary Purpose

Social Phobia, Anxiety, Behavior Therapy

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Face-to-face Virtual Reality Exposure Therapy
Internet-administered Virtual Reality Exposure Therapy
Waiting-list
Sponsored by
Stockholm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

One-session VRET face-to-face

Waiting-list, then Internet-administered VRET

Arm Description

One-session Virtual Reality Exposure Therapy led by therapist (face-to-face), followed by a 4-week therapist-guided Internet-administered progressive maintenance program.

4-week waiting list, followed by therapist-guided, Internet-administered VRET with a 4-week progressive maintenance program.

Outcomes

Primary Outcome Measures

Public Speaking Anxiety Scale
Self-rating of public speaking anxiety

Secondary Outcome Measures

Liebowitz Social Anxiety Scale Self-Report
Self-rating of general social anxiety
Brief Fear of Negative Evaluation Scale
Self-rating of fear of negative evaluation
Patient Health Questionnaire 9-item
Self-rating of depressive symptoms
Generalized Anxiety Disorder 7-item
Self-rating of general anxiety symptoms
Brunnsviken Brief Quality of life scale
Self-rating of quality of life

Full Information

First Posted
December 20, 2016
Last Updated
March 6, 2019
Sponsor
Stockholm University
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1. Study Identification

Unique Protocol Identification Number
NCT03001154
Brief Title
Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software
Acronym
VRETORIK
Official Title
Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockholm University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia, Anxiety, Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-session VRET face-to-face
Arm Type
Experimental
Arm Description
One-session Virtual Reality Exposure Therapy led by therapist (face-to-face), followed by a 4-week therapist-guided Internet-administered progressive maintenance program.
Arm Title
Waiting-list, then Internet-administered VRET
Arm Type
Experimental
Arm Description
4-week waiting list, followed by therapist-guided, Internet-administered VRET with a 4-week progressive maintenance program.
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face Virtual Reality Exposure Therapy
Intervention Description
In session, systematic, hierarchical exposure to feared stimuli with therapist.
Intervention Type
Behavioral
Intervention Name(s)
Internet-administered Virtual Reality Exposure Therapy
Intervention Description
Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program
Intervention Type
Other
Intervention Name(s)
Waiting-list
Intervention Description
Weekly assessments of public speaking
Primary Outcome Measure Information:
Title
Public Speaking Anxiety Scale
Description
Self-rating of public speaking anxiety
Time Frame
Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21
Secondary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale Self-Report
Description
Self-rating of general social anxiety
Time Frame
Change from baseline: Week 0, 5 and 21
Title
Brief Fear of Negative Evaluation Scale
Description
Self-rating of fear of negative evaluation
Time Frame
Change from baseline: Week 0, 5 and 21
Title
Patient Health Questionnaire 9-item
Description
Self-rating of depressive symptoms
Time Frame
Change from baseline: Week 0, 5 and 21
Title
Generalized Anxiety Disorder 7-item
Description
Self-rating of general anxiety symptoms
Time Frame
Change from baseline: Week 0, 5 and 21
Title
Brunnsviken Brief Quality of life scale
Description
Self-rating of quality of life
Time Frame
Change from baseline: Week 0, 5 and 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Psychology
City
Stockholm
ZIP/Postal Code
10691
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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