Using Immersive Virtual Reality to Treat Pediatric Anxiety

Specific Phobia Clinical Trial

Official title:

Virtually Better: Using Immersive Virtual Reality to Treat Pediatric Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504773
• Other study ID #: IRB00210075
• Status: Completed
• Phase: N/A
• Start date: September 17, 2020
• Est. completion date: February 14, 2023

Study information

• Verified date: December 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 14, 2023
• Est. primary completion date: January 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Childhood Anxiety Disorder
• Phobic Disorders
• Specific Phobia
• Specific Phobia, Animal
• Specific Phobia, Natural Environment
• Specific Phobia, Situational

Intervention

Behavioral:
• Virtual Reality Exposure Therapy
Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Severity Rating (CSR) of Targeted Specific Phobia on Anxiety Disorder Interview Schedule for Children and Parents (ADIS-C/P)	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.	1 week after virtual reality exposure therapy session
Secondary	Screen for Childhood Anxiety and Related Disorders-Parent Report (SCARED-P)	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.	1 week after virtual reality exposure therapy session