Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and OCD

Study Overview
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Brief Summary
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Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. Investigators aim to enhance this therapy with the use of virtual reality exposures and to make therapy more available and accessible for patients with anxiety disorders. The societal benefit of increased access to therapy is that, if successful, it will increase the number of patients who receive appropriate treatment for an anxiety disorder.

Detailed Description
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Twenty children with CADs or OCD who have received less than 3 treatment sessions and a parent will be recruited to pilot the VR system. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic. Each patient will participate in a single (up to) 2-hour visit. During the first 30 minutes the patient and parent will be introduced to the VR system and the rationale for this feasibility study. Next, a therapist will lead the patient through exposure exercises using the VR system for up to 30 minutes. During the next period, up to 30 minutes, the therapist will go to a different room and the patient, with support from their parent, will complete exposure exercises using the VR system that the therapist directed them to complete. During the exposures the interviewer will observe, code and record the patient's interaction with the VR system. For the remaining time (up to 30 minutes) the interviewer will interview the patient about his or her experience with the VR system and then will ask for observations and opinions from the parent.

Official Title
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Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders

Conditions
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Anxiety, Obsessive Compulsive Disorder

Intervention / Treatment
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* Other: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 7 to 12 Primary diagnosis of anxiety, generalized anxiety disorder, social phobia, separation anxiety and/or OCD Exclusion Criteria: History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism or major depressive disorder. Current suicidality or recent suicidal behavior Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties Starting or changing the dosage of a psychiatric medication in the last 2 months

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 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: Single Arm<br>The children in this study will have a single visit. During this visit the child and their parent will be introduced to the virtual reality (VR) system. The child will interact with the VR system and after they have finished, they will be asked questions about their experience with the VR system. | Other: Virtual Reality<br>* Use of virtual reality to deliver exposure therapy<br>* Other names: Google Cardboard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Subjective Units of Distress Scale (SUDS) at end of session | The SUDS - 0 to 10 ratings, where 0 indicates that they feel no anxiety at all and 10 indicates that they are experiencing maximum distress | approximately 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of children to describe the virtual reality system as engaging and easy to use based on qualitative interviews | The ease of use of the VR system | approximately 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, OCD, Obsessive Compulsive Disorder, Generalized Anxiety, Social Phobia, Separation Anxiety, GAD, Youth, Teen, Therapy