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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02713516

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Obsessive Compulsive Disorder	Other: Virtual Reality	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm 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 Use of virtual reality to deliver exposure therapy Other Names: Google Cardboard

Arm

Intervention/Treatment

Experimental: Single Arm

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

Use of virtual reality to deliver exposure therapy

Other Names:

Google Cardboard

Outcome Measures

Primary Outcome Measures

Mean change from baseline in Subjective Units of Distress Scale (SUDS) at end of session [approximately 2 hours]
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

Secondary Outcome Measures

Percent of children to describe the virtual reality system as engaging and easy to use based on qualitative interviews [approximately 2 hours]
The ease of use of the VR system

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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