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

NCT02713516 | Completed

• 1 other identifier: 15-008235
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Obsessive Compulsive Disorder

Keywords

Anxiety; OCD; Obsessive Compulsive Disorder; Generalized Anxiety; Social Phobia; Separation Anxiety; GAD; Youth; Teen; Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  approximately 2 hours

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

Virtual Reality OTHER

Use of virtual reality to deliver exposure therapy

Also known as: Google Cardboard

Single Arm

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Phobia, Social; Anxiety, Separation

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Neurodevelopmental Disorders

Study Officials

• Stephen P Whiteside, PhD., L.P.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: August 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 31, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)