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

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder; Anxiety
• Intervention / Treatment: Other: Virtual Reality

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 7 to 12
2. Primary diagnosis of anxiety, generalized anxiety disorder, social phobia, separation anxiety and/or OCD

Exclusion Criteria:

1. History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism or major depressive disorder.
2. Current suicidality or recent suicidal behavior
3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
4. Starting or changing the dosage of a psychiatric medication in the last 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

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 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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Stephen P Whiteside, PhD., L.P., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: OCD; Anxiety; Social Phobia; Therapy; Obsessive Compulsive Disorder; Youth; GAD; Teen; Separation Anxiety; Generalized Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders
• Other Study ID Numbers: 15-008235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are collecting user acceptability/feasibility data in a small pilot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No