Virtual Reality for Anxiety

Overseen By Sylvie Le May, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Epilepsy, Cannot sit upright, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

98 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated with sedation. Very few studies seemed to have looked at the effect of immersive virtual reality (IVR) on anxiety in children scheduled for an MRI. Objectives: The aims of this study are two-fold: 1- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 2- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety during MRIs. Methods: This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to address the feasibility and acceptability of the use of virtual reality. Following the field test, a RCT will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department's protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CHU Sainte-Justine's, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic, clinical characteristics, measures of anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological biomarkers of anxiety such as alpha-amylase and other markers such as heart rate and head deviation will also be measured. Measures of healthcare professionals, parents, and participants' level of satisfaction will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05. Discussion: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. It will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for an MRI.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Virtual Reality Therapy for anxiety?

Research shows that Virtual Reality Therapy can effectively treat anxiety disorders by providing controlled exposure to anxiety-inducing situations in a safe, immersive environment. Studies have found positive effects of VR-based exposure therapy, indicating it can be a convenient and cost-effective treatment option for anxiety. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating anxiety disorders?

Research shows that virtual reality therapy is generally safe for treating anxiety disorders, with no significant difference in dropout rates compared to traditional exposure therapy. It is considered as effective and stable over time as classical treatments. ^{5 6 7 8 9}

How is virtual reality treatment for anxiety different from other treatments?

Virtual reality treatment for anxiety is unique because it creates an immersive, interactive 3D environment that allows patients to experience exposure therapy in a controlled and safe setting, unlike traditional in-person exposure therapy which can be difficult to access and more stressful for patients. ^{5 6 9 10 11}

Research Team

Sylvie Le May, PhD

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

This trial is for children aged 7 to 17 who need an MRI and have a parent or guardian who can consent in French or English. It's designed to see if playing a virtual reality game before the scan helps with anxiety.

Inclusion Criteria

My parent or guardian who speaks English or French will accompany me and can consent.

I am between 7 and 17 years old.

Required to undergo MRI

Exclusion Criteria

I cannot play virtual reality games due to epilepsy or another condition.

I can sit in a semi-upright position for the VR session.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Field Test Phase

A field test phase with 10 participants to address the feasibility and acceptability of the VR intervention

Not specified

1 visit (in-person)

Randomized Controlled Trial (RCT)

Participants are divided into two groups: experimental group receiving pre-procedural IVR game preparation and usual care group receiving standard care

Not specified

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Virtual Reality

Trial Overview The study tests whether a pre-procedural immersive VR game can reduce anxiety during MRIs compared to standard care. Participants will be randomly assigned to either the VR group or usual care, with equal numbers in each group.

Participant Groups

Group I: Virtual Reality Distraction Experimental Treatment 1 Intervention

Use of Virtual Reality (VR) before the MRI.

Group II: Standard Treatment Active Control 1 Intervention

Standard Treatment used at the radiology department.

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Findings from Research

In a study involving 20 stroke survivors, multiuser virtual reality (MU VR) therapy led to significantly greater arm movement (414.6m) compared to single-user (SU VR) therapy (327.0m), indicating that MU VR may enhance physical engagement during rehabilitation.

Participants showed high compliance with both therapy modes (99% for MU and 89% for SU), and overall motor recovery, as measured by the Fugl-Meyer Assessment, improved significantly across all participants, suggesting that MU VR can effectively extend clinical therapy into home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Thielbar, KO., Triandafilou, KM., Barry, AJ., et al.[2020]

A systematic review of 17 studies involving 827 participants found that virtual reality (VR) applications can significantly reduce anxiety symptoms compared to passive control groups, with a strong effect size of 1.29.

While VR applications showed a non-significant overall effect compared to conventional therapies, they provide a valuable treatment option, especially when traditional therapies are not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of virtual reality applications in the treatment of anxiety disorders: A systematic review and meta-analysis of randomized-controlled trials. Schröder, D., Wrona, KJ., Müller, F., et al.[2023]

Virtual reality (VR) is an effective and immersive tool for treating psychiatric disorders, particularly anxiety, by providing controlled sensory stimulation in a three-dimensional environment.

The review highlights the empirical evidence supporting VR-based interventions and suggests that VR can be a convenient and cost-effective addition to traditional psychiatric treatments, with recommendations for its integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Maples-Keller, JL., Bunnell, BE., Kim, SJ., et al.[2022]

Virtual Reality Based Exposure Therapy (VRBET) showed positive effects in treating agoraphobia in a trial with 10 participants, indicating its potential as an effective standalone treatment.

Combining VRBET with cognitive therapy did not result in significant improvements over VRBET alone, suggesting that VRBET may be sufficient for addressing agoraphobia without the need for additional cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. Malbos, E., Rapee, RM., Kavakli, M.[2011]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

Virtual reality exposure therapy for anxiety disorders is shown to be safe and effective, often matching the efficacy of traditional in-person exposure therapy.

The increasing availability of affordable virtual reality systems and the development of self-guided programs could significantly enhance access to treatment for anxiety disorders, potentially addressing mental health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. Anderson, PL., Molloy, A.[2021]

Virtual reality exposure therapy (VRET) significantly outperforms waitlist controls in treating anxiety disorders, indicating its effectiveness as an intervention.

When compared to traditional evidence-based treatments, VRET shows similar efficacy and stability of results over time, suggesting it can be a viable alternative or complement to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. Opriş, D., Pintea, S., García-Palacios, A., et al.[2012]

A review of 27 randomized controlled trials (RCTs) on virtual reality exposure therapy (VRET) for anxiety disorders found that the overall quality of the studies was low, with an average adherence to only 2.85 out of 8 research design criteria.

While VRET appears to be an effective treatment option, the variability in study quality and the reduction in effect size for larger sample sizes suggest that caution is needed when interpreting the results and comparing VRET to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. McCann, RA., Armstrong, CM., Skopp, NA., et al.[2022]

Virtual reality therapy is proposed as an effective alternative to traditional exposure methods in cognitive behavioral therapy for anxiety disorders, showing at least equivalent efficacy to in vivo exposure for conditions like specific phobias and PTSD.

The immersive nature of virtual reality creates a strong sense of 'presence,' enhancing the therapeutic experience and suggesting that it may function as an embodied therapy rather than just a method of exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in the care management of anxiety disorders]. Levy, F., Rautureau, G., Jouvent, R.[2019]

The SoREAL-trial is a clinical study involving 302 patients with social anxiety disorder and/or agoraphobia, comparing traditional in-person cognitive behavioral therapy (CBT-in vivo) to virtual reality-based exposure therapy (CBT-in virtuo) over a 14-week treatment period.

The primary outcomes will assess specific anxiety symptoms using validated scales, with the trial aiming to provide insights into the efficacy and patient satisfaction of virtual reality exposure as a potentially less aversive alternative to traditional exposure therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy with virtual reality exposure versus group cognitive behavioural therapy with in vivo exposure for social anxiety disorder and agoraphobia: a protocol for a randomised clinical trial. Arnfred, B., Bang, P., Hjorthøj, C., et al.[2022]

Virtual reality (VR) exposure therapy has been shown to be effective for treating anxiety disorders, with a growing focus on complex conditions like social anxiety disorder, beyond just specific phobias.

The advancement of VR technology has established it as both a therapeutic tool and a research method, highlighting the need for further studies on its efficacy in treating various anxiety disorders and understanding the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of virtual reality as an exposure technique]. Diemer, J., Zwanzger, P.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of virtual reality applications in the treatment of anxiety disorders: A systematic review and meta-analysis of randomized-controlled trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. [2011]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Maximizing the impact of virtual reality exposure therapy for anxiety disorders. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. [2012]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. [2022]

9. Argentina pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in the care management of anxiety disorders]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy with virtual reality exposure versus group cognitive behavioural therapy with in vivo exposure for social anxiety disorder and agoraphobia: a protocol for a randomised clinical trial. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Development of virtual reality as an exposure technique]. [2020]