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

NCT06338800 | Not Yet Recruiting

• 1 other identifier: PSY-2324-S-0134
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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. 1.What are the expectations of children and adolescents and therapists with VR exposure?
2. 2.What is the acceptability of the VR session (positive and negative effects)?
3. 3.What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR.

Conditions

Anxiety Disorders; Exposure; Social Anxiety Disorder

Keywords

Children; Adolescents; Virtual Reality Exposure; Anxiety disorders

Outcome Measures

Primary Outcomes (1)

• Willingness to participate in exposure in vivo

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

  Directly before and immediately after the session

Secondary Outcomes (4)

• Idiosyncratic expectations

  During the session

• Anxiety

  During the session

• Expectations of Virtual Reality

  Directly before the session

• Acceptability

  Immediately after the session

Study Arms (1)

One session VR Exposure

EXPERIMENTAL

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

Behavioral: One session exposure with Virtual Reality

Interventions

One session exposure with Virtual Reality BEHAVIORAL

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

One session VR Exposure

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Severe psychiatric symptoms other than anxiety disorder interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.

Sponsors & Collaborators

• Accare: lead

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Social

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Central Study Contacts

Rianne Hornstra, PhD.

CONTACT

(050) 368 11 00; r.hornstra@accare.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 1, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data can be requested after publication.