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OpenTrials
Completed

NCT Number: NCT03636022

Virtual Reality System for Anxiety and OCD

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR System

Other

Use of virtual reality to deliver exposure therapy

Control

Other

Use of conventional delivery of exposure therapy

Primary outcomes

  1. Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1

    Time frame: Baseline and End of Session I, 2 hours

    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.

  2. Maximum SUDS Rating During Crossover Exposure

    Time frame: 2 hours

    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.

Secondary outcomes

  1. Homework Engagement

    Time frame: 1 week

    Number of homework exposures completed.

Sponsors and collaborators

Lead sponsor

Minnesota HealthSolutions

Industry

Collaborators

  • Mayo Clinic

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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