Clinical trial NCT06338800: One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents
Official title: One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Exposure
Social Anxiety Disorder
Keywords: Children
Adolescents
Virtual Reality Exposure
Anxiety disorders
Lead sponsor: Accare
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Willingness to participate in exposure in vivo
timeFrame: Directly before and immediately after the session
Secondary outcomes:
measure: Idiosyncratic expectations
timeFrame: During the session
measure: Anxiety
timeFrame: During the session
measure: Expectations of Virtual Reality
timeFrame: Directly before the session
measure: Acceptability
timeFrame: Immediately after the session
Other outcomes:
Locations:
Study officials:
References: