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

NCT ID: NCT06338800

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-31

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.

Conditions

Anxiety Disorders; Exposure; Social Anxiety Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One session VR Exposure

All participants will receive one session exposure therapy with virtual reality during ongoing treatment.

Group Type: EXPERIMENTAL

One session exposure with Virtual Reality

Intervention Type: BEHAVIORAL

Participants will receive one session exposure with virtual reality from their therapists.

Interventions

One session exposure with Virtual Reality

Participants will receive one session exposure with virtual reality from their therapists.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Rianne Hornstra, PhD.

Role: CONTACT

r.hornstra@accare.nl

(050) 368 11 00

Other Identifiers

PSY-2324-S-0134

Identifier Type: -

Identifier Source: org_study_id