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Virtual Reality System for Anxiety and OCD

Primary Purpose

Anxiety, Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR System
Control
Sponsored by
Minnesota HealthSolutions
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 Disorder, Social Phobia, Separation Anxiety, GAD, Youth, Teen, Therapy, Specific Phobia, Children

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 7 to 17
  2. Primary diagnosis of an anxiety disorder or obsessive compulsive disorder.

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 sucidality 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 psychiatric medications in the last 2 months.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

VR System

Control Condition

Arm Description

Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.

Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.

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 participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2018
Last Updated
July 6, 2023
Sponsor
Minnesota HealthSolutions
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03636022
Brief Title
Virtual Reality System 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
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minnesota HealthSolutions
Collaborators
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
Yes

5. Study Description

Brief Summary
Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. The investigators aim to enhance this therapy with the use of virtual reality exposures. The human subjects study will test the effects of using VR for exposures compared to traditional imaginal exposures on anxiety symptom improvement, functioning, child engagement in an response to exposures, completion of exposure homework between treatment sessions, and length of treatment in weeks and length of treatment among children with anxiety disorders and/or obsessive compulsive disorder. The funding award supports the development of the technology and the human subjects study. The subcontract to Mayo supports expert input to identify clinically relevant content for therapeutic videos on the VR system and the human subjects study to test the VR system.
Detailed Description
Seventy children with childhood anxiety disorders (CADs) or obsessive compulsive disorder (OCD) and a parent will be recruited to test the Phase II VR system with a randomized controlled mixed methods study. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC). Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control, respectively. All participants in the study will participate in an introductory session in which participants complete two exposures related to content from their fear ladder, one with the VR system and analogous imaginal exposure. Each family will receive instructions for how to use the Mayo Clinic Anxiety Coach tablet app to record exposures during home practice. Participants will then be assigned one week of daily exposure homework for the intervention and control conditions. Participants randomized to the intervention condition will take home the VR system for homework completion and participants assigned to control will be instructed to complete imaginal exposures. One week after the introductory session, all participants will return for a session in which participants complete both types of exposure. Participants will also be assigned to a third generalization exposure, i.e., an exposure related to the baseline exposure that is higher on the fear ladder, to complete at their next anxiety clinic treatment sessions. SUDS ratings for each type of exposure will be recorded electronically via the Mayo Clinic Anxiety Coach. During the follow up session, an independent interviewer will observe participants' engagement during exposure and will interview participants and their parents about their experience with both types of exposure.

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 Disorder, Social Phobia, Separation Anxiety, GAD, Youth, Teen, Therapy, Specific Phobia, Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR System
Arm Type
Experimental
Arm Description
Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.
Arm Title
Control Condition
Arm Type
Experimental
Arm Description
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Intervention Type
Other
Intervention Name(s)
VR System
Intervention Description
Use of virtual reality to deliver exposure therapy
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Use of conventional delivery of 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 participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 7 to 17 Primary diagnosis of an anxiety disorder or obsessive compulsive disorder. 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 sucidality 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 psychiatric medications in the last 2 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget Biggs, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be made available through the National Database for Clinical Trials Related to Mental Illness
IPD Sharing Time Frame
6 months following the study completion
IPD Sharing Access Criteria
To be determined by the National Institute of Mental Health
IPD Sharing URL
http://ndct.nimh.nih.gov

Learn more about this trial

Virtual Reality System for Anxiety and OCD

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