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Not yet recruiting NCT06338800

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

No phase Interventional Anxiety Disorders Exposure Social Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: One session exposure with Virtual Reality.
Who it may be relevant to
Registry conditions: Anxiety Disorders, Exposure, Social Anxiety Disorder. Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Willingness to participate in exposure in vivo [Time frame: Directly before and immediately after the session]
Secondary outcome measures (4)
  • Idiosyncratic expectations [Time frame: During the session]
  • Anxiety [Time frame: During the session]
  • Expectations of Virtual Reality [Time frame: Directly before the session]
  • Acceptability [Time frame: Immediately after the session]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06338800 · PSY-2324-S-0134

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗