VR Therapy for Parental Anxiety

Overseen By Thomas J Caruso, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cognitive impairment, Motion sickness, Nausea, Seizures, Visual problems, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 20-30 minutes

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Virtual Reality headset with calming scenery can reduce anxiety for parents whose children are in the hospital. It compares this VR experience to no technological distraction to determine which better eases stress. Participants will either use the VR headset or join a group without any technology. Parents with children undergoing procedures at specific hospitals, who do not have issues like severe motion sickness or seizures, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance hospital experiences for families.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual reality headset is safe for parental and pediatric populations?

Past studies have shown that virtual reality (VR) therapy can reduce anxiety in people with anxiety disorders. Research indicates that most people tolerate VR therapy well. Many users report positive experiences, with only a few discontinuing due to negative effects.

No major reports of serious problems, such as those requiring hospitalization, have emerged. This suggests that using a VR headset for treatment is likely safe for most people. However, individual experiences can vary, so consulting a healthcare professional before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for parental anxiety, which often involve medication or traditional therapy sessions, this virtual reality therapy immerses parents in calming virtual environments. The unique delivery method via a VR headset provides a novel and engaging way to help parents manage anxiety. Researchers are excited about this approach because it offers a non-invasive, drug-free alternative that could deliver rapid relief by allowing users to experience tranquility in an immersive setting.

What evidence suggests that this virtual reality therapy is effective for parental anxiety?

Research has shown that virtual reality (VR) therapy, which participants in this trial may receive, can help lower anxiety. Studies have found that VR therapy benefits people with anxiety disorders. A review of several studies found that VR therapy effectively treats specific fears and social anxiety. It is safe to use, with no major side effects reported. Calming VR experiences can distract and relax users, potentially reducing their anxiety. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for parents aged 18-99 who can give consent. It's not suitable for those with current nausea, significant cognitive impairment, severe motion sickness history, seizures, visual problems or whose children are clinically unstable.

Inclusion Criteria

Able to consent

Exclusion Criteria

Significant Cognitive Impairment

People who do not consent

Patients whose children are clinically unstable or require urgent/emergent intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are exposed to a virtual reality environment for 20-30 minutes to assess its effectiveness in reducing anxiety

20-30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for anxiety levels post-intervention using validated questionnaires

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality headset with calming scenery

Trial Overview

The study tests if using a Virtual Reality headset showing calming scenery can better prevent anxiety in parents compared to standard care without tech-based distractions.

How Is the Trial Designed?

Group I: Virtual Reality Experimental Treatment 1 Intervention

Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes

Group II: Control Active Control 1 Intervention

No intervention (i.e. virtual reality headset) will be applied to the participant.

Virtual Reality headset with calming scenery is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as VR Therapy for:

• Anxiety Disorders
• Social Anxiety Disorder
• Generalized Anxiety Disorder

Approved in United States as Virtual Reality Exposure Therapy for:

• Anxiety Disorders
• Post-Traumatic Stress Disorder (PTSD)
• Phobias

Approved in Canada as VR Headset Therapy for:

• Anxiety Disorders
• Depression
• Stress Management

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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]

A study involving 45 patients with fear of flying found that virtual reality (VR) exposure therapy significantly reduced fear levels, while cognitive treatment alone did not show similar benefits.

Both types of VR exposure (with and without motion simulation) were equally effective, suggesting that the key factor in reducing fear was the visual and acoustic stimuli provided by the VR environment, rather than the motion simulation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a one-session virtual reality exposure treatment for fear of flying. Mühlberger, A., Wiedemann, G., Pauli, P.[2022]

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]

In a study involving 31 participants with specific phobias, both cognitive-behavioral therapy (CBT) combined with virtual reality exposure therapy (VRET) and CBT with real image exposure significantly reduced anxiety and phobia levels, with effects maintained at a 3-month follow-up.

Despite the reduction in subjective anxiety, brain imaging (fMRI) revealed that certain brain areas still showed signs of fear response, particularly the amygdala, indicating that while therapy was effective, some fear responses persisted at the neural level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Brain Activation through Cognitive-Behavioral Therapy with Exposure to Virtual Reality: A Neuroimaging Study of Specific Phobia. Álvarez-Pérez, Y., Rivero, F., Herrero, M., et al.[2021]

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 (VR) exposure therapy has shown promise as an effective and cost-efficient alternative to traditional exposure therapy for treating anxiety disorders, particularly in reducing fear of heights and fear of flying.

The initial controlled studies indicate that VR can successfully immerse participants in a virtual environment, which may enhance therapeutic outcomes for various anxiety-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy. Rothbaum, BO., Hodges, L., Kooper, R.[2012]

A systematic review of 28 studies indicates that head-mounted display virtual reality (HMD-VR) is an effective tool for treating various anxiety disorders, including specific phobias and social anxiety, through virtual reality exposure therapy (VRET).

HMD-VR can enhance occupational therapy by creating realistic environments that help clients confront anxiety triggers, potentially improving therapeutic outcomes through immersive experiences that simulate real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for the Treatment of Anxiety Disorders: A Scoping Review. Donnelly, MR., Reinberg, R., Ito, KL., et al.[2022]

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 (VRET) has shown effectiveness in treating specific anxiety disorders, particularly fear of heights and flying, by immersing patients in a computer-generated environment.

However, the effectiveness of VRET for other phobias remains unclear, indicating a need for more randomized clinical trials to compare VRET directly with standard exposure therapy and to evaluate its efficacy as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy of anxiety disorders: a review. Krijn, M., Emmelkamp, PM., Olafsson, RP., et al.[2004]

A single-session automated Virtual Reality exposure therapy (VRET) for fear of spiders demonstrated a significant reduction in phobia symptoms (effect size d = 1.26) in a study of 25 participants, with effects maintained at a six-month follow-up.

The intervention was found to be practical and tolerable, suggesting that automated VRET could serve as an effective self-help treatment for specific phobias in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamified, Automated Virtual Reality Exposure Therapy for Fear of Spiders: A Single-Subject Trial Under Simulated Real-World Conditions. Lindner, P., Miloff, A., Bergman, C., et al.[2022]

Virtual reality exposure therapy (VRET) significantly reduces acrophobia symptoms compared to no treatment, with effects lasting up to 6 months after therapy.

There was no difference in effectiveness between VRET using a head-mounted display (HMD) and a computer automatic virtual environment (CAVE), suggesting that both methods are equally effective for treating acrophobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acrophobia in virtual reality: the role of immersion and presence. Krijn, M., Emmelkamp, PM., Biemond, R., et al.[2019]

Virtual Reality Exposure Therapy (VRE) and Cognitive Therapy (CT) were found to be equally effective as Cognitive-Behavior Therapy (CBT) in reducing public speaking anxiety (PSA) in a study involving subjects who received 12 therapy sessions.

While CT showed some superiority over VRE on one behavioral measure, VRE was better at reducing fear during a behavioral task, indicating that both therapies can be effective options for treating PSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure versus cognitive restructuring for treatment of public speaking anxiety: a pilot study. Wallach, HS., Safir, MP., Bar-Zvi, M.[2018]

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