Pilot Study: VR Mind and VR Mind+ Intervention

Study Overview
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Brief Summary
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The aim of the pilot study is feasibility, usability and safety assessment of VR Mind intervention. In particular the subject of assessment will be: the length of the laboratory session utilizing virtual reality exposure (feasibility), the ergonomics and ease of use for both patients and system operators (usability), the frequency of side effect occurrence as a result of virtual reality exposure (ie. Vertigo) (safety). The results pilot study will be used in the designing a clinical trial aimed for testing efficacy and safety of VR Mind intervention.

Detailed Description
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In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The pilot investigators will be tested for the feasibility, usability and safety of the system in order to obtain information useful in further designs for the clinical trial. The research consists of four laboratory sessions. The first and the last session will be dedicated to participant assessment. During the second and third session the virtual reality scenarios (2 x 10 minutes for each session) will be presented to participants. The participants will be playing a role of someone who is giving a speech (Public speaking scenario) and someone who is speaking on a phone in public (Telephoning in public scenario).

Official Title
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Pilot Study: Feasibility, Usability and Safety Assessment of VR Mind and VR Mind+ Intervention

Conditions
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Social Phobia

Intervention / Treatment
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* Behavioral: VR Mind


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-50 y.o. Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD). Signing informed consent Exclusion Criteria: Occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview) Occurrence and/or recognition: psychosis, bipolar disorder, mental retardation Exclusion based on interview: pregnancy, drug addiction, alcohol addiction, participating in the experimental session while intoxicated (current) neurological treatment of chronic disease of central nervous system, epilepsy, paroxysmal vertigo, presence of suicidal thoughts , tendencies or attempts, participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR Mind<br>Two VR Mind sessions using experimental virtual reality scenarios. During these two sessions, participants will be exposed to virtual reality environment, for 2 x 10 min each session. | Behavioral: VR Mind<br>* Two VR Mind sessions using virtual reality scenarios concerning social situations in which social phobics are prone to experience anxiety. The pilot study will consist of two scenarios: Public Speaking in Lecture Hall and Telephoning in Public. Two sessions are planned, each containing two expositions to virtual reality environment, each lasting 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility_1: Number of participants, who have completed 4 laboratory sessions within 2 weeks. | Number of participants, who have completed 4 laboratory sessions within 2 weeks. | At the end of 4th laboratory session within 2 weeks | 
| Feasibility_2: Number of virtual reality exposure sessions completed in predefined time. | Number of virtual reality exposure sessions completed in predefined time. | At the end of 2nd and 3th laboratory session within 2 weeks | 
| Usability_ 3: immersion, perceived reality and engagement | 3 items with 7-point scale, where 1 is Totally agree and 7 Totally disagree: The virtual reality immersed me in all aspects (Immersion), The virtual reality resembled true experiences (Reality), The virtual reality was engaging (Engagement). | At the end of 2 and 3 laboratory session within 2 weeks | 
| Safety_1: occurrence and severity of simulator sickness | Simulator sickness is expected adverse effect of the VR. Hence, the Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993) will be administered as a primary outcome measure to evaluate safety of the VR intervention. Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores >10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as: mild (no intervention required, all VR sessions completed), moderate (any intervention needed, e.g. session termination), severe (hospitalization required), life-threatening / death. Any unexpected adverse effects will be recorded by a physician and classified as described above. | During 2nd and 3th laboratory session within 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vr, virtual reality, social phobia, vret, virtual reality exposure therapy