Virtual Reality System for Anxiety and OCD

M

Minnesota HealthSolutions

Status

Completed

Conditions

Obsessive-Compulsive Disorder
Anxiety

Treatments

Other: Control
Other: VR System

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03636022
MinnesotaHealthSolutions

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

7 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 2 patient groups

VR System
Experimental group
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.
Treatment:
Other: VR System
Control Condition
Experimental group
Description:
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Treatment:
Other: Control

Trial contacts and locations

1

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Central trial contact

Deanna R Hofschule; Bridget K Biggs, Ph.D., L.P.

Data sourced from clinicaltrials.gov

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