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

NCT ID: NCT02713516

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-05-31

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.

Conditions

Anxiety; Obsessive Compulsive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: OTHER

Use of virtual reality to deliver exposure therapy

Interventions

Virtual Reality

Use of virtual reality to deliver exposure therapy

Intervention Type: OTHER

Other Intervention Names

Google Cardboard

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Stephen Whiteside

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen P Whiteside, PhD., L.P.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

15-008235

Identifier Type: -

Identifier Source: org_study_id