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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338800
• Other study ID #: PSY-2324-S-0134
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Accare
• Contact: Rianne Hornstra, PhD.
• Phone: (050) 368 11 00
• Email: r.hornstra[@]accare.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Exposure
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• One session exposure with Virtual Reality
Participants will receive one session exposure with virtual reality from their therapists.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Accare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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