VR Mind and VR Mind+ Intervention

Study Overview
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Brief Summary
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The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.

Detailed Description
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In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind and VR Mind+. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions. The research consists of fourteen sessions. The first and the last session will be dedicated to participant assessment. Subsequent sessions 2-13 will be performed according to the therapy protocol for each arm. Control group of participants (active comparative arm) will receive standard treatment for social anxiety disorder - cognitive behavioral therapy based on the protocol developed by the Principal Investigator [protocol adapted from the approach of Clark and Wells (Mayo-Wilson, Dias, Mavranezouli, 2014)]. Experimental group 1 will receive cognitive behavioral therapy with exposure in virtual environment. Experimental group 1 and control group were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. All treatment session will be led by licensed therapist. Participants of the experimental group 2 will independently conducts the self-therapy process. The intervention will consist of 12 therapeutic sessions. At each of the 12 sessions, the participant will selects a specific scenario of social situations that arouse fear (e.g. public speaking, job interview or other situations from everyday life). Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will last no longer than 20 minutes for each session.

Official Title
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VR Mind™ and VR Mind +™ Intervention - Randomized, Open Label, Single Masking, Parallel Group Clinical Trial

Conditions
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Social Phobia

Intervention / Treatment
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* Behavioral: Virtual Reality Exposure Therapy VR Mind+
* Behavioral: Virtual Reality Exposure Therapy VR Mind
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD). Signing informed consent Unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated Exclusion Criteria: occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview) psychosis, bipolar disorder, mental retardation pregnancy, drug addiction, alcohol addiction, psychoactive substances 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 current CBT treatment for Social Anxiety Disorder

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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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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: VR Mind+<br>Virtual Reality Exposure Therapy VR Mind+ | Behavioral: Virtual Reality Exposure Therapy VR Mind+<br>* Virtual Reality Exposure Self-Therapy led by a participant<br>|
| Experimental: Group 2: VR Mind<br>Virtual Reality Exposure Therapy VR Mind | Behavioral: Virtual Reality Exposure Therapy VR Mind<br>* Treatment with Virtual Reality Exposure Therapy led by a therapist<br>|
| Active Comparator: Control group: CBT<br>Cognitive Behavioral Therapy | Behavioral: Cognitive Behavioral Therapy<br>* Standard treatment for social phobia led by a therapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) | The scale is composed of 24 items, depicting various social situations. For each item, participants assess their fear (from 1 - No fear to 4 - Severe) and avoidance (from 1 - Never to 4 - Usually). LSAS has 3 scores, summing the results for particular items - fear (0-72), avoidance (0-72) and total score (0-144). | change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks) | 
| Safety: Occurrence and severity of Simulator Sickness - Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993) | Simulator sickness is expected adverse effect of the VR.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), moderate (any intervention needed, e.g. session termination), severe (hospitalization required), life-threatening / death. Some of the symptoms of anxiety may produce similar side effects as a simulator sickness. The results obtained in this case will be false positive. Therefore assessment of side effects for each case will be verified if the increase in SSQ score was triggered by rapid relapse of phobia symptoms. | Change from session to session with virtual reality exposure: at session 1, session 7 (4 weeks), session 8 (4 weeks), session 10 (5 weeks), session 11 (6 weeks) and session 12 (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression | Clinical Global Impression (CGI; Guy, 1976) - is a single item, 7 point scale used by clinicians to assess the severity of illness, where 1 is labeled as Normal, not at all ill and 7 is labeled as Among the most extremely ill patients. | Pre-treatment at session 1 | 
| Clinician Global Impressions of Improvement | Global measure of change in severity of symptoms, ranging from 1 labeled as  Very much improved to 7 labeled as Very much worse. | Post-treatment, approximately 7 weeks after initial session | 
| Patient Global Impression | Patient Global Impression - is a single item, 4 point scale used by patients to assess their impression of severity of their illness and quality of their functioning in everyday life, where 1 is labeled as Normal and 4 is labeled as Severe. | Pre-treatment at session 1 | 
| Patient Global Impressions of Improvement | Global measure of change in severity of symptoms, where 1 is labeled as No change and 7 is labeled as  Very much improved . | Post-treatment, approximately 7 weeks after initial session | 
| Beck Depression Inventory | A 21-question multiple-choice self-report inventory for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression | Pre-treatment at session 1 to post-treatment at session 14 (7 weeks) | 

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