Virtual Reality Exposure Therapy for Public Speaking Anxiety

Study Overview
=================
Brief Summary
-----------------
Virtual Reality exposure therapy (VRET) is an efficacious treatment for anxiety disorders but has yet to be implemented in regular care settings. This is arguably due to the limitations of the past generation of VR technology, which was expensive, inaccessible, cumbersome and hard to use. With the advent of consumer VR technology, VRET is now ready for implementation in regular care. This multiple-baseline trial will examine the effectiveness of VRET for public speaking anxiety (PSA) when delivered under real-world conditions at an ordinary, non-specialized mental health clinic, by clinical psychologist with only brief VRET training. Participants will either be self-referred specifically for this treatment, or come through ordinary clinical channels. Self-rated PSA will serve as primary outcome measure and will be measured three times prior to treatment (at screening and twice after a diagnostic screening telephone interview) , four times after onset, at the end of the treatment period, and three months after treatment.

Official Title
-----------------
Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial

Conditions
-----------------
Public Speaking, Social Anxiety, Social Anxiety Disorder, Performance Only

Intervention / Treatment
-----------------
* Behavioral: In-session Virtual Reality exposure therapy
* Behavioral: Internet-administered transition program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have substantial public speaking anxiety (PSAS >= 60) Can travel to PBM clinic on one occasion and pay stipulated patient fee Can speak and understand sufficient Swedish Have stable access to the internet 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
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Multiple baseline
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OST-VRET + in-vivo transition program<br>One-session treatment (OST) VRET on-location with clinical psychologist (3 hours), followed by a therapist-guided, four-week online program encouraging transition to real-world, in-vivo exposure exercises. | Behavioral: In-session Virtual Reality exposure therapy<br>* A series of exposure exercises (speech exercises) in front of a virtual audience, focusing on promoting inhibitory learning, with audio-feedback.<br>* Other names: Cognitive behavioral therapy;Behavioral: Internet-administered transition program<br>* Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.<br>* Other names: Internet intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline: Public Speaking Anxiety Scale | Canonical total score will be used. Measure is self-rated, online. Swedish translation of the original PSAS (Bartholomay & Houlihan, 2016) | Change from baseline: (1) five days after interview, (2) ten days after interview, (3) 7 days post-OST, (4) 14 days post-OST (5) 21 days post-OST (6) 28 days post-OST, (7) 35 days post-OST, (8) 125 days post-PST | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline: Brunnsviken Brief Quality of life scale | Canonical total score will be used. Measure is self-rated, online. | Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST | 
| Change from baseline: Liebowitz Social Anxiety Scale Self-Report | Canonical total score will be used. Measure is self-rated, online. | Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST | 
| Change from baseline: Brief Fear of Negative Evaluation Scale | Canonical total score will be used. Measure is self-rated, online. | Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST | 
| Change from baseline: Patient Health Questionnaire 9-item | Canonical total score will be used. Measure is self-rated, online. | Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST | 
| Change from baseline: Generalized Anxiety Disorder 7-item | Canonical total score will be used. Measure is self-rated, online. | Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST |