oVRcome Self-guided Virtual Reality for Specific Phobias

Study Overview
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Brief Summary
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Specific phobias: fear of flying, heights, spiders, dogs and needles are the extremely common and exposure therapy (ET) is the first line of treatment. Using Virtual Reality (VR), participants will have control in gradual exposure to their fears. oVRcome (https://www.ovrcome.io/ Virtual reality app), is a self-help VRET for 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. The investigators hypothesize that oVRcome is effective in reducing specific phobia symptoms.

Official Title
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oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial

Conditions
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Specific Phobia

Intervention / Treatment
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* Other: Smartphone application (app) in combination with headset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: are between 18-64 years old Have a fear of flying, heights, spiders, dogs, needles and score above 4 on the Brief Standard Self rating scale for phobic patients (Marks, I. Matthews ,A (1979) Behaviour Research and Therapy) have access to a smart phone and internet willing to participate in the research study and providing informed consent Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19 have insufficient knowledge of the English language are under current treatment for specific 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

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 specific phobia, 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: Smartphone application (app) in combination with headset<br>* The intervention oVRcome is self-help VRET for specific phobia, 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 |
| --- | --- | --- |
| Severity Measure for Specific Phobia-Adult American Psychological Association | The Severity Measure for Specific Phobia-Adult is a 10-item self-report measure that assesses the severity of specific phobia in individuals age 18 and older. The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Standard Self rating scale for phobic patients | The total score can range from 0 to 8 with higher scores indicating greater severity of specific phobia | 6 weeks, 12 weeks, 18 weeks | 
| Clinical Global Impression of Change (CGI-C) | CGI-C scores range from 1 (very much improved) through to 7 (very much worse) | weekly (Weeks 1-6) | 
| Patient Health Questionnaire - PHQ 9 | PHQ-9 scores range from 1 through to 27, with higher scores indicating more severe depressive symptoms | 6 weeks, 12 weeks, 18 weeks | 
| Subjective Units of Distress Scale | Scores range from 1 through to 100 with higher scores indicating higher levels of distress | Week 4, 5 and 6 | 
| Modified Gatineau Presence Questionnaire First item | Scores range from 1 (very realistic) through to 100 (not very realistic) | Week 4, 5 and 6 | 
| Fast Motion Sickness Scale (FMS) | Scores range from zero (no sickness at all) to 20 (frank sickness). | Week 4, 5 and 6 | 
| Brief Fear of Negative Evaluation Scale | Scores range from 1 through to 60 with higher scores indicating higher fear of negative evaluation | 6 weeks, 12 weeks, 18 weeks | 
| Changes in behaviour that may have been previously avoided because of the phobia | Free text response | Weeks 6 and 12 |