Using Immersive Virtual Reality to Treat Pediatric Anxiety

Not Applicable

Completed

• Conditions: Specific Phobia, Situational; Specific Phobia, Natural Environment; Specific Phobia; Childhood Anxiety Disorder; Specific Phobia, Animal
• Interventions: Behavioral: Virtual Reality Exposure Therapy

• Registration Number: NCT04504773
• Lead Sponsor: Johns Hopkins University

Brief Summary

Anxiety is a common and impairing problem for children. The principle treatment for pediatric anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise called exposures. While exposures are effective, some feared situations cannot be confronted in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to rely on imagined exposures, and/or (3) requires families to complete exposures outside of the therapy visits. This creates a burden for clinicians and families, and impedes treatment success. Immersive virtual reality (VR) presents an innovative solution that allows children to face fears without leaving the clinician's office. While VR has been used to distract children during painful medical procedures, it has not been well examined as a primary treatment for pediatric anxiety. This study proposes to examine the effectiveness and acceptability of using immersive VR exposures to treat children and adolescents with specific phobias.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Study Start: 2020-09-17
• Primary Completion: 2022-01-12
• Status Verified: 2022-12
• Study Completion: 2023-02-14
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• 8-17 years (inclusive),
• meet diagnostic criteria for one or more phobias on a structured diagnostic interview (ADIS-C/P). This specifically includes natural environments (e.g., storms, heights) and/or situational settings (e.g., airplanes, public speaking).
• be fluent in English.

Exclusion Criteria

• unable to complete rating scales, or
• attend study visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality Exposure Therapy	Virtual Reality Exposure Therapy	Participants will receive a single session of exposure therapy to address specific phobia that includes the use of virtual reality exposures.

Primary Outcome Measures

Name	Time	Method
Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)	1 week after virtual reality exposure therapy session	The ADIS-C/P CSR for the Specific Phobia is a single item rating that is made by a clinician. Scores are made on a 9-point scale that ranges from 0 (Not at all) to 8 (Very, very much). A score of 4 or greater considered to be indicative of a psychiatric disorder.

Secondary Outcome Measures

Name	Time	Method
Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)	1 week after virtual reality exposure therapy session	Parent-reported rating of child anxiety that consists of 41-items. Items are rated on a 3-point scale that ranges from 0 (Not True) to 2 (Very True). The total score ranges from 0 to 82, with a total score of 25 or greater may indicate the presence of an anxiety disorder.

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States