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Clinical Trials/NCT06338800
NCT06338800Not yet recruitingNot Applicable

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

Accare0 sites30 target enrollmentStarted: September 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Primary Endpoint
Willingness to participate in exposure in vivo

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 18 Years (Child, Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

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

  • Idiosyncratic expectations(During the session)
  • Anxiety(During the session)
  • Acceptability(Immediately after the session)
  • Expectations of Virtual Reality(Directly before the session)

Investigators

Sponsor
Accare
Sponsor Class
Other
Responsible Party
Sponsor

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