oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder

Study Overview
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Brief Summary
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Social anxiety is characterised by excessive fear of being negatively judged, embarrassed or humiliated during social interactions and is common with a lifetime prevalence of 12.1%. Cognitive behavioural therapy is the first line of treatment, but people may not seek treatment due to a number of factors including the discomfort experienced in seeking help, inconvenience, and the experience of psychotherapy itself. With Virtual Reality (VR), users can have increased control in how gradually they expose themselves to social situations. In studies of VR in people with specific phobias, 76% of people prefer VR exposure to in vivo exposure. There is emerging evidence for the use of VR in social phobia. oVRcome, is a self-help VRET for social anxiety symptoms and specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video. This study will evaluate the effectiveness of the oVRcome social anxiety program for social anxiety symptoms. We hypothesize that oVRcome will reduce social anxiety symptom severity over a 6-week treatment period compared to waiting-list control

Official Title
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oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder. A Randomised Controlled Trial.

Conditions
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Social Anxiety

Intervention / Treatment
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* Other: oVRcome phone app with headset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are between 18-64 years old have moderate (or higher) social anxiety disorder symptoms on Liebowitz social anxiety scale (>60) have access to a smart phone and internet willing to participate in the research study and providing informed consent Exclusion Criteria: present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19, =3 on suicidality item have insufficient knowledge of the English language are under current treatment for social phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone application (app) in combination with headset<br>The intervention oVRcome is self-help VRET for social anxiety, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly. | Other: oVRcome phone app with headset<br>* The intervention oVRcome is self-help VRET for social anxiety, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly.<br>|
| No Intervention: Waitlist<br>Participants in the waitlist condition will be offered the intervention directly after post-test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz social anxiety scale -self report (LSAS) | Assesses the way that social phobia plays a role in participants life across a variety of situations. Higher scores indicate more severe symptoms. Min 0 Max 144 | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fear of Negative Evaluation Scale | Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation | week 0,6,12,18 | 
| Patient's Global Impressions of Improvement (PGI-I) scale | Assesses patients' overall perception of their condition in a 1-item questionnaires that ask an individual patient to rate the perceived change in his/her condition in response to therapy at endpoint. Min 1 (very much improved) Max 7 (very much worse). | Week 1,2,3,4,5,6,7,8,9,10,11,12,18 | 
| Patient Health Questionnaire - PHQ 9 | PHQ-9 scores range from 0 through to 27, with higher scores indicating more severe depressive symptoms | Week 0,6,12,18 | 
| Modified Gatineau Presence Questionnaire First item | Assess degree of realism using virtual reality. Scores range from 1 (very realistic) through to 100 (not very realistic) | Week 4,5,6 | 
| Fast Motion Sickness Scale (FMS) | Measures motion sickness with virtual reality. Scores range from zero (no sickness at all) to 20 (frank sickness). | Week 4,5,6 | 
| Changes in behaviour that may have been previously avoided because of the phobia | Free text response | Week 6,12,18 |