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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06338800
Enrollment
30
Registered
2024-04-01
Start date
2024-09-30
Completion date
2025-12-31
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Exposure, Social Anxiety Disorder

Keywords

Children, Adolescents, Virtual Reality Exposure, Anxiety disorders

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.

Interventions

BEHAVIORALOne session exposure with Virtual Reality

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

Sponsors

Accare
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

During ongoing treatment for their anxiety disorder 30 children and adolescents (8-18 years) with an anxiety disorder will receive a session of exposure with VR. Before the session expectations of VR exposure will be assessed. Before and after the session willingness to participate in exposure in vivo will be measured. During the session anxiety, idiosyncratic expectations, and self-efficacy are measured. After the session, positive effects, experiences, and negative side effects will be asked for.

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Willingness to participate in exposure in vivoDirectly before and immediately after the sessionParticipants will be asked about their willingness to participate in exposure in vivo

Secondary

MeasureTime frameDescription
Idiosyncratic expectationsDuring the sessionSpecific idiosyncratic expectations of the children and the adolescents, rated on a likert scale ranging from 0-10 (a higher score is a stronger belief).
AnxietyDuring the sessionAnxiety 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).
Expectations of Virtual RealityDirectly before the sessionExpectations of the session with virtual reality will be assessed with the Credibility and Expectancy Questionnaire for therapists and children.
AcceptabilityImmediately after the sessionAcceptability 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.

Contacts

Primary ContactRianne Hornstra, PhD.
r.hornstra@accare.nl(050) 368 11 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026