Virtual Reality System for Anxiety and OCD

NCT03636022 | Completed Results DMC

• 1 other identifier: MinnesotaHealthSolutions
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Obsessive-Compulsive Disorder

Keywords

Anxiety; OCD; Obsessive Compulsive Disorder; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety; GAD; Youth; Teen; Therapy; Specific Phobia; Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Homework Engagement

  1 week

Study Arms (2)

VR System

EXPERIMENTAL

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

Control Condition

EXPERIMENTAL

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

Other: Control

Interventions

VR System OTHER

Use of virtual reality to deliver exposure therapy

VR System

Control OTHER

Use of conventional delivery of exposure therapy

Control Condition

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minnesota HealthSolutions: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Phobia, Social; Anxiety, Separation; Phobia, Specific

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Neurodevelopmental Disorders

Results Point of Contact

• Title: Sara Seifert
• Organization: Minnesota HealthSolutions

sara@minnhealth.com

6128036998

Study Officials

• Bridget Biggs, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: November 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months following the study completion
• Access Criteria: To be determined by the National Institute of Mental Health

Locations

US (1)