Virtual Reality System for Anxiety and OCD

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Anxiety
• Intervention / Treatment: Other: VR System; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR System; 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.	Other: VR System; Use of virtual reality to deliver exposure therapy
Experimental: Control Condition; Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.	Other: Control; Use of conventional delivery of exposure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1	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. The mean change in SUDS during the Session VR exposure versus mean change in SUDS during the conventional (control condition) verbal imaginal exposure.	Baseline and End of Session I, 2 hours
Maximum SUDS Rating During Crossover Exposure	Crossover exposure refers to the Session 2 virtual reality exposure for the control group and to the Session 2 imaginal exposure for the virtual reality group. The SUDs Rating Scale, or Subjective Units of Distress Scale (SUDs) is used to measure the intensity of distress or anxiety. The SUDs is a self-assessment tool rated on a scale from 0 to 10. Ten represents the highest level of distress and 0 represents no distress.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homework Engagement	Number of homework exposures completed.	1 week

Collaborators and Investigators

• Sponsor: Minnesota HealthSolutions
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Bridget Biggs, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: OCD; Generalized Anxiety Disorder; Anxiety; Children; Social Phobia; Therapy; Obsessive Compulsive Disorder; Youth; GAD; Teen; Specific Phobia; Separation Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders
• Other Study ID Numbers: MinnesotaHealthSolutions

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No