Virtual Reality System for Anxiety and OCD

Study Overview
=================
Brief Summary
-----------------
Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. The investigators aim to enhance this therapy with the use of virtual reality exposures. The human subjects study will test the effects of using VR for exposures compared to traditional imaginal exposures on anxiety symptom improvement, functioning, child engagement in an response to exposures, completion of exposure homework between treatment sessions, and length of treatment in weeks and length of treatment among children with anxiety disorders and/or obsessive compulsive disorder. The funding award supports the development of the technology and the human subjects study. The subcontract to Mayo supports expert input to identify clinically relevant content for therapeutic videos on the VR system and the human subjects study to test the VR system.

Detailed Description
-----------------
Seventy children with childhood anxiety disorders (CADs) or obsessive compulsive disorder (OCD) and a parent will be recruited to test the Phase II VR system with a randomized controlled mixed methods study. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC). Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control, respectively. All participants in the study will participate in an introductory session in which participants complete two exposures related to content from their fear ladder, one with the VR system and analogous imaginal exposure. Each family will receive instructions for how to use the Mayo Clinic Anxiety Coach tablet app to record exposures during home practice. Participants will then be assigned one week of daily exposure homework for the intervention and control conditions. Participants randomized to the intervention condition will take home the VR system for homework completion and participants assigned to control will be instructed to complete imaginal exposures. One week after the introductory session, all participants will return for a session in which participants complete both types of exposure. Participants will also be assigned to a third generalization exposure, i.e., an exposure related to the baseline exposure that is higher on the fear ladder, to complete at their next anxiety clinic treatment sessions. SUDS ratings for each type of exposure will be recorded electronically via the Mayo Clinic Anxiety Coach. During the follow up session, an independent interviewer will observe participants' engagement during exposure and will interview participants and their parents about their experience with both types of exposure.

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

Conditions
-----------------
Anxiety, Obsessive-Compulsive Disorder

Intervention / Treatment
-----------------
* Other: VR System
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 7 to 17 Primary diagnosis of an anxiety disorder or obsessive compulsive disorder. 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 sucidality 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 psychiatric medications in the last 2 months.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR System<br>Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework. | Other: VR System<br>* Use of virtual reality to deliver exposure therapy<br>|
| Experimental: Control Condition<br>Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures. | Other: Control<br>* Use of conventional delivery of exposure therapy<br>|

What is the study measuring?
-----------------
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 participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress. | 2 hours | 

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