Anxiety DisordersNCT06338800
One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents
A study testing One session exposure with Virtual Reality in people with Anxiety Disorders and Exposure, run by Accare.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Anxiety Disorders, Exposure, Social Anxiety Disorder
- What is being tested?
- One session exposure with Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Severe psychiatric symptoms other than anxiety disorder interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.
Trial locations and contacts
No sites are listed yet.
About this study
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:
- What are the expectations of children and adolescents and therapists with VR exposure?
- What is the acceptability of the VR session (positive and negative effects)?
- What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR.
Read the 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.
- Conditions
- Anxiety Disorders, Exposure, Social Anxiety Disorder
- Being tested
- One session exposure with Virtual Reality
- Keywords
- Children, Adolescents, Virtual Reality Exposure, Anxiety disorders
- Medical subject headings
- Anxiety Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One session exposure with Virtual RealityBehavioural
Participants will receive one session exposure with virtual reality from their therapists.
| Study group | Role | What they receive |
|---|---|---|
| One session VR Exposure | Experimental | All participants will receive one session exposure therapy with virtual reality during ongoing treatment. Receives: Behavioral: One session exposure with Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to participate in exposure in vivo
Participants will be asked about their willingness to participate in exposure in vivo
Measured: Directly before and immediately after the session
Secondary outcomes (4)
Idiosyncratic expectations
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).
Measured: During the session
Anxiety
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).
Measured: During the session
Expectations of Virtual Reality
Expectations of the session with virtual reality will be assessed with the Credibility and Expectancy Questionnaire for therapists and children.
Measured: Directly before the session
Acceptability
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.
Measured: Immediately after the session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338800
- Sponsor's protocol ID
- PSY-2324-S-0134
- Status last verified
- Aug 2024
- First submitted
- 19 Mar 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will ask permission to share the data for potential future reanalysis, such as in a individual participant meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06338800
- Acronym / sponsor ID
- PSY-2324-S-0134
- Conditions
- Anxiety Disorders, Exposure, Social Anxiety Disorder
- Keywords
- Children, Adolescents, Virtual Reality Exposure, Anxiety disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AccareUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the expectations of children and adolescents and therapists with VR exposure?
- What is the acceptability of the VR session (positive and negative effects)?
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| One session VR Exposure | Experimental | Behavioral: One session exposure with Virtual RealityAll participants will receive one session exposure therapy with virtual reality during ongoing treatment. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe psychiatric symptoms other than anxiety disorder interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One session exposure with Virtual RealityParticipants will receive one session exposure with virtual reality from their therapists. | Behavioural | One session VR Exposure |
Primary outcome
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
4 secondary outcomes
Idiosyncratic expectations
Time frame: During the session
Anxiety
Time frame: During the session
Expectations of Virtual Reality
Time frame: Directly before the session
Acceptability
Time frame: Immediately after the session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. We will ask permission to share the data for potential future reanalysis, such as in a individual participant meta-analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing One session exposure with Virtual Reality in people with Anxiety Disorders and Exposure, run by Accare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rianne Hornstra, PhD. ((050) 368 11 00, r.hornstra@accare.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to participate in exposure in vivo (time frame: Directly before and immediately after the session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.