One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents

The goal of this study is to evaluate one session with exposure with Virtual Reality (VR) in in children and adolescents, aged 8-18 years with an anxiety disorder. The main questions it aims to answer are:

1. What are the expectations of children and adolescents and therapists with VR exposure?
2. What is the acceptability of the VR session (positive and negative effects)?
3. What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Disorders; Social Anxiety Disorder; Exposure
• Intervention / Treatment: Behavioral: One session exposure with Virtual Reality

Detailed Description

Cognitive behavioral therapy is an effective treatment for anxiety disorders, with exposure as the most important working ingredient. Exposure therapy can be challenging to implement in face-to-face settings. Virtual reality (VR) has emerged as a promising tool for delivering exposure therapy.

In the current study, the researchers will examine children and adolescents that will participate in a single session of VR exposure during their regular treatment (n=30). Willingness to participate in exposure in vivo will be assessed directly before and directly after the session. During the session anxiety, idiosyncratic expectations, and self-efficacy will be assessed. Expectations will be measured before the session and acceptability after the session.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rianne Hornstra, PhD.; Phone Number: (050) 368 11 00; Email: r.hornstra@accare.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children and adolescents 8-18 years old.
• Meeting Diagnostic and Statistical Manual of Mental Disorders -5 criteria for an anxiety disorder, based on a semi-structured interview (SCID-5 Jr, specific section) or clinical judgment of an experienced and authorized clinician.

Exclusion Criteria:

• Severe psychiatric symptoms other than anxiety disorder interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One session VR Exposure; All participants will receive one session exposure therapy with virtual reality during ongoing treatment.	Behavioral: One session exposure with Virtual Reality; Participants will receive one session exposure with virtual reality from their therapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Willingness to participate in exposure in vivo	Participants will be asked about their willingness to participate in exposure in vivo	Directly before and immediately after the session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Idiosyncratic expectations	Specific idiosyncratic expectations of the children and the adolescents, rated on a likert scale ranging from 0-10 (a higher score is a stronger belief).	During the session
Anxiety	Anxiety of the children and adolescents will be rated on a likert-scale, subjective units of distress (SUD-scores) ranging from 0-10 (a higher score is more anxiety).	During the session
Expectations of Virtual Reality	Expectations of the session with virtual reality will be assessed with the Credibility and Expectancy Questionnaire for therapists and children.	Directly before the session
Acceptability	Acceptability of virtual reality exposure will be assessed with a questionnaire specifically designed for this study. Youth will be asked about positive and negative effects and their experiences.	Immediately after the session

Collaborators and Investigators

• Sponsor: Accare

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Children; Anxiety disorders; Virtual Reality Exposure
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: PSY-2324-S-0134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will ask permission to share the data for potential future reanalysis, such as in a individual participant meta-analysis.
• IPD Sharing Time Frame: Data can be requested after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No