Skip to main content
OpenTrials
Completed

NCT Number: NCT02713516

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

Use of virtual reality to deliver exposure therapy

Other names: Google Cardboard

Primary outcomes

  1. Mean change from baseline in Subjective Units of Distress Scale (SUDS) at end of session

    Time frame: 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 outcomes

  1. Percent of children to describe the virtual reality system as engaging and easy to use based on qualitative interviews

    Time frame: approximately 2 hours

    The ease of use of the VR system

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2016
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.