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

Primary Purpose

Anxiety, Obsessive Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring Anxiety, OCD, Obsessive Compulsive Disorder, Generalized Anxiety, Social Phobia, Separation Anxiety, GAD, Youth, Teen, Therapy

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2016
Last Updated
November 9, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02713516
Brief Title
Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and OCD
Official Title
Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Obsessive Compulsive Disorder
Keywords
Anxiety, OCD, Obsessive Compulsive Disorder, Generalized Anxiety, Social Phobia, Separation Anxiety, GAD, Youth, Teen, Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
Google Cardboard
Intervention Description
Use of virtual reality to deliver exposure therapy
Primary Outcome Measure Information:
Title
Mean change from baseline in Subjective Units of Distress Scale (SUDS) at end of session
Description
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
Time Frame
approximately 2 hours
Secondary Outcome Measure Information:
Title
Percent of children to describe the virtual reality system as engaging and easy to use based on qualitative interviews
Description
The ease of use of the VR system
Time Frame
approximately 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen P Whiteside, PhD., L.P.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are collecting user acceptability/feasibility data in a small pilot

Learn more about this trial

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

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