Skip to main content
Clinical Trials/NCT02713516
NCT02713516
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country40 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Mayo Clinic
Enrollment
40
Locations
1
Primary Endpoint
Mean change from baseline in Subjective Units of Distress Scale (SUDS) at end of session
Status
Completed
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
May 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Whiteside

Associate Professor of Psychology

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Percent of children to describe the virtual reality system as engaging and easy to use based on qualitative interviews(approximately 2 hours)

Study Sites (1)

Loading locations...

Similar Trials