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

Not Applicable

Not yet recruiting

• Conditions: Anxiety Disorders; Exposure; Social Anxiety Disorder
• Interventions: Behavioral: One session exposure with Virtual Reality

• Registration Number: NCT06338800
• Lead Sponsor: Accare

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Study Start: 2024-09
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One session VR Exposure	One session exposure with Virtual Reality	All participants will receive one session exposure therapy with virtual reality during ongoing treatment.

Primary Outcome Measures

Name	Time	Method
Willingness to participate in exposure in vivo	Directly before and immediately after the session	Participants will be asked about their willingness to participate in exposure in vivo

Secondary Outcome Measures

Name	Time	Method
Idiosyncratic expectations	During the session	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).
Anxiety	During the session	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).
Acceptability	Immediately after the session	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.
Expectations of Virtual Reality	Directly before the session	Expectations of the session with virtual reality will be assessed with the Credibility and Expectancy Questionnaire for therapists and children.