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NCT Number: NCT06338800

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

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

One session exposure with Virtual Reality

Behavioral

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

Primary outcomes

  1. Willingness to participate in exposure in vivo

    Time frame: Directly before and immediately after the session

    Participants will be asked about their willingness to participate in exposure in vivo

Secondary outcomes

  1. Idiosyncratic expectations

    Time frame: 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).

  2. Anxiety

    Time frame: 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).

  3. Expectations of Virtual Reality

    Time frame: Directly before the session

    Expectations of the session with virtual reality will be assessed with the Credibility and Expectancy Questionnaire for therapists and children.

  4. Acceptability

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rianne Hornstra, PhD.

CONTACT

[email protected]

(050) 368 11 00

Sponsors and collaborators

Lead sponsor

Accare

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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