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

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.

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

Conditions
-----------------
Social Phobia, Anxiety, Behavior Therapy

Intervention / Treatment
-----------------
* Behavioral: Face-to-face Virtual Reality Exposure Therapy
* Behavioral: Internet-administered Virtual Reality Exposure Therapy
* Other: Waiting-list


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-session VRET face-to-face<br>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<br>* In session, systematic, hierarchical exposure to feared stimuli with therapist.<br>|
| Experimental: Waiting-list, then Internet-administered VRET<br>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<br>* Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program<br>Other: Waiting-list<br>* Weekly assessments of public speaking<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Public Speaking Anxiety Scale | Self-rating of public speaking anxiety | Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale Self-Report | Self-rating of general social anxiety | Change from baseline: Week 0, 5 and 21 | 
| Brief Fear of Negative Evaluation Scale | Self-rating of fear of negative evaluation | Change from baseline: Week 0, 5 and 21 | 
| Patient Health Questionnaire 9-item | Self-rating of depressive symptoms | Change from baseline: Week 0, 5 and 21 | 
| Generalized Anxiety Disorder 7-item | Self-rating of general anxiety symptoms | Change from baseline: Week 0, 5 and 21 | 
| Brunnsviken Brief Quality of life scale | Self-rating of quality of life | Change from baseline: Week 0, 5 and 21 |