Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps to Improve Focus, Attention and Reduce Worry & Rumination.

Study Overview
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Brief Summary
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This is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the safety and efficacy of OVR Health's VR experience to improve control over the focus of attention and reduce worry and rumination in individuals who have reported problems with these issues.

Official Title
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Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps Individuals to Improve Focus, Attention and Reduce Worry & Rumination.

Conditions
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Anxiety, Depression, Anxiety

Intervention / Treatment
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* Device: OVR Health's VR experience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 years old Must be in good general health Self-reported with the following symptoms (as assessed by questions and questionnaires in study material): Finding it hard to let go of difficult thoughts. Looking out for signs of a potential threat in their environment (or in their body) that unhelpfully maintains their problem. Engaging in repetitive, unhelpful patterns of negative thinking (worry & rumination). • These may be due to a diagnosis of a mental health condition, but this is not required for entry into the study. Good understanding of written and spoken English Willing and able to give informed consent Willing and able to follow the study protocol Willing and able to use VR headset at home WiFi connection to connect VR headset at home Willing and able to return VR headset Exclusion Criteria: Current diagnosis of epilepsy, dementia, or another neurological disease that may prevent the use of VR hardware and software Individuals with suicidal or self-harm thoughts Significant visual, auditory, or balance impairment Insufficient comprehension of English Primary diagnosis of alcohol or substance abuse disorder, or personality disorder • Significant learning disability Current active suicidal plans or self-harm (in which case participant will be referred to appropriate crisis service) Receiving current alternative psychotherapy treatment Unwilling to provide consent Unwilling to follow the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VR - coaching arm<br>30 individuals to be enrolled in the intervention arm that also includes coaching sessions to support and encourage VR use (VR+coaching arm). | Device: OVR Health's VR experience<br>* Virtual reality experience<br>|
| Active Comparator: VR only - no coaching<br>30 individuals to be enrolled in the intervention arm without coaching (VR arm) | Device: OVR Health's VR experience<br>* Virtual reality experience<br>|
| No Intervention: No intervention - control arm<br>30 individuals to be enrolled in the control arm with no active intervention (comparator 2; control arm) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of virtual reality device and reduction in worry and rumination (PHQ9) | Changes in perceived safety using the PHQ9 questionnaire (Scale 0-3). | 5 weeks | 
| Safety of virtual reality device and reduction in worry and rumination (Perseverative Thinking score ) | Changes in perceived safety using the Perseverative Thinking score (Scale 0-4). | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of coaching on virtual reality intervention effectiveness (PHQ9) | Changes in the PHQ9 questionnaire (0-3) in comparison to Group 2 (no coaching) and placebo arm (no intervention) with a lower score showing fewer symptoms. | 5 weeks | 
| Impact of coaching on virtual reality intervention effectiveness (Perseverative Thinking scor) | Changes in the Perseverative Thinking score (0-4) in comparison to Group 2 (no coaching) and placebo arm (no intervention) with a lower score showing fewer symptoms. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality