Virtual Reality for Mental Health

Overseen By Thomas J Caruso, MD, MEd

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Caruso

Disqualifiers: Seizure disorder, Nausea, Motion sickness, 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: Unknown

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Virtual Reality (VR) can increase confidence in children and young adults regarding their healthcare. Participants will use VR during in-patient care to determine if it enhances their self-efficacy, or belief in their ability to succeed. The trial compares VR with standard hospital care (Standard of Care) by alternating the order of these treatments over two days. It suits patients aged 5 to 25 who do not have conditions like seizures or motion sickness and who do not wear glasses incompatible with VR headsets. As an unphased trial, this study provides a unique opportunity to explore innovative care methods and contribute to groundbreaking research.

Will I have to stop taking my current medications?

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

What prior data suggests that this virtual reality intervention is safe for pediatric patients?

Research has shown that virtual reality (VR) in mental health care is generally safe and well-tolerated. Studies have found that VR treatments for issues like phobias and PTSD (post-traumatic stress disorder) do not cause major negative effects. Many participants report feeling better emotionally and less stressed after VR sessions, indicating that the treatment is not only safe but also helpful. Although VR is a newer tool in healthcare, current research supports its safety for mental health treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality for mental health because it offers a unique and immersive way to engage patients compared to traditional therapies like medication or talk therapy. Unlike standard treatments, virtual reality provides a controlled environment where patients can safely explore and work through their feelings or fears, potentially leading to quicker and more profound insights. This method could also make therapy more accessible and engaging, especially for younger patients or those who find it challenging to open up in conventional settings.

What evidence suggests that Virtual Reality is effective for increasing self-efficacy in pediatric patients?

Research shows that virtual reality (VR) can aid mental health treatments. For example, studies have found that VR significantly reduces PTSD (post-traumatic stress disorder) symptoms compared to traditional therapy. VR-based exposure therapy achieves success rates between 60% and 90% when treating specific fears, depending on the fear and the individual. In this trial, participants will experience both VR therapy and standard care in different sequences. These findings suggest that VR could be a promising tool for boosting confidence in healthcare, especially for young patients. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for pediatric patients aged 5 to 25 at LPCH/SHC facilities looking to improve their self-efficacy in healthcare settings. It's not suitable for those who are pregnant, clinically unstable, non-consenting, use corrective glasses (incompatible with VR), prone to motion sickness or seizures, or currently nauseous.

Inclusion Criteria

I am between 5 and 25 years old and treated at LPCH/SHC.

Exclusion Criteria

Current use of corrective glasses (not compatible with VR headset)

Participants who do not consent

Current motion sickness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either standard care or virtual reality intervention on the first day, and the alternate intervention on the second day of in-patient care

2 days

In-patient care

Follow-up

Participants are monitored for changes in self-efficacy, mental well-being, and self-esteem after the intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care
• Virtual Reality

Trial Overview The study is testing whether using Virtual Reality (VR) can boost self-confidence in young patients during healthcare compared to the usual care without VR. Participants will be randomly assigned to receive either the standard of care alone or with an additional educational VR experience.

How Is the Trial Designed?

Group I: Virtual Reality then Standard of Care Experimental Treatment 2 Interventions

Participants will be randomized to receive the virtual reality intervention on the first day and receive standard of care on the second day of in-patient care.

Group II: Standard of Care then Virtual Reality Experimental Treatment 2 Interventions

Participants will be randomized to receive the standard of care on the first day and receive virtual reality intervention on the second day of in-patient care.

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?

Thomas Caruso

Lead Sponsor

Trials

2

Recruited

220+

Published Research Related to This Trial

A systematic review of three short-term trials involving 156 participants found that virtual reality had minimal effects on treatment compliance and cognitive functioning in individuals with serious mental illness, indicating low efficacy for these outcomes.

While participants reported greater satisfaction with the virtual reality intervention compared to standard care, the overall evidence quality was low, and further high-quality studies are needed to better understand the potential benefits and risks of using virtual reality in mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for treatment compliance for people with serious mental illness. Välimäki, M., Hätönen, HM., Lahti, ME., et al.[2022]

Virtual reality (VR) therapy has shown positive results for treating anxiety disorders, particularly phobic disorders, and is recommended in current German treatment guidelines.

While VR applications for posttraumatic stress disorder (PTSD) are still in early development, advancements in mobile and cost-effective VR solutions hold promise for enhancing psychotherapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[VR-supported therapy for anxiety and posttraumatic stress disorder: current possibilities and limitations]. Diemer, J., Kothgassner, OD., Herrmann, MJ., et al.[2023]

Over 50 studies on virtual reality (VR) applications for mental health were identified, mostly consisting of case studies, with some focusing on specific phobias and anxiety disorders.

While VR therapy shows promise as a treatment option, current research does not sufficiently demonstrate its effectiveness compared to traditional therapeutic methods, highlighting the need for more rigorous controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality in mental health : a review of the literature. Gregg, L., Tarrier, N.[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]

Immersive virtual reality (VR) shows great promise as a tool for improving psychological interventions, potentially making treatments more effective and accessible for a larger number of patients.

To fully realize the benefits of VR in mental health therapy, further well-designed studies are needed to explore its efficacy, efficiency, and cost-effectiveness compared to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in immersive virtual reality interventions for mental disorders: A new reality? Geraets, CNW., van der Stouwe, ECD., Pot-Kolder, R., et al.[2021]

Virtual reality (VR) is being increasingly utilized by mental health professionals to enhance treatment outcomes for various conditions, including specific phobias, posttraumatic stress disorder, eating disorders, and pain management.

Research indicates that VR has immersive properties that can significantly improve clinical interventions, making it a promising tool in modern mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: using the virtual world to improve quality of life in the real world. Anderson, PL., Rothbaum, BO., Hodges, L.[2019]

Virtual reality exposure therapy (VRET) has emerged as a promising alternative for treating anxiety disorders, particularly in cases where traditional imaginal exposure therapy is challenging to implement, allowing for controlled exposure to phobic stimuli in a safe environment.

High levels of 'immersion' and 'presence' during VRET are linked to better therapeutic outcomes, enabling therapists to tailor exposure intensity to individual patient needs, although the technology requires specialized training and can have mild side effects like nausea or dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in anxiety disorders]. Mitrousia, V., Giotakos, O.[2017]

Virtual reality (VR) technology has shown promising effectiveness in treating various psychiatric conditions, particularly anxiety disorders, and is also being explored for conditions like eating disorders, addictions, autism, ADHD, and schizophrenia.

Current VR interventions primarily target symptoms that are challenging to treat with medication, such as auditory hallucinations and delusions, but more rigorous research, including long-term studies, is needed to fully establish their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual Reality in psychiatry and psychotherapy]. Simon, L., Pénzváltó, T., Vass, E.[2021]

The study aims to explore the initial expectations and experiences of psychiatric staff and patients regarding automated virtual reality (VR) therapy, specifically the gameChange program, which is designed to help patients overcome anxiety and re-engage with everyday activities.

By conducting focus groups across 5 NHS mental health trusts, the research seeks to gather insights on the feasibility of implementing VR therapy in psychiatric wards, potentially increasing access to psychological treatments for inpatients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Cognitive Therapy in Inpatient Psychiatric Wards: Protocol for a Qualitative Investigation of Staff and Patient Views Across Multiple National Health Service Sites. Brown, P., Waite, F., Lambe, S., et al.[2023]

Patients and staff expressed strong enthusiasm for the gameChange VR therapy on psychiatric wards, believing it could help build confidence and reduce anxiety as patients prepare for discharge.

The main barrier to implementing VR therapy was the need for sufficient private space, but overall, both patients and staff felt that VR could be integrated into current care with proper support and training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Virtual Reality Cognitive Therapy (gameChange) in Inpatient Psychiatric Wards: Qualitative Study of Staff and Patient Views Using an Implementation Framework. Brown, P., Waite, F., Lambe, S., et al.[2023]

Virtual reality (VR) therapy has shown positive outcomes for various clinical conditions, including anxiety disorders and chronic pain, indicating its potential as a novel therapeutic approach.

Despite its successes, implementing VR in clinical research faces challenges such as theoretical immaturity and a lack of technical standards, which need to be addressed to enhance the rigor and clinical relevance of future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Clinical Research: Promises and Challenges. Garrett, B., Taverner, T., Gromala, D., 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]

Integrating virtual reality (VR) with existing evidence-based treatments for eating disorders, like cue exposure therapy, shows promise in improving treatment outcomes and reducing dropout rates, which currently affect about 24% of patients.

The paper emphasizes the need for a structured clinical protocol to support the implementation of VR-based interventions, aiming to enhance their acceptance and effectiveness in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing Virtual Reality From Clinical Trials to Clinical Practice for the Treatment of Eating Disorders: An Example Using Virtual Reality Cue Exposure Therapy. Brown, T., Nauman Vogel, E., Adler, S., et al.[2020]

Participants with psychosis reported significant improvements in managing agoraphobic avoidance after using gameChange VR therapy, particularly those with severe avoidance, highlighting its efficacy as a therapeutic tool.

The immersive VR scenarios allowed users to confront their anxieties in a safe environment, enabling them to learn new coping strategies and gradually apply these skills in real-world situations, suggesting a promising mechanism for anxiety reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. Bond, J., Kenny, A., Pinfold, V., et al.[2023]

Citations

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Exploring the potential of virtual reality (VR) in mental ... Their findings indicated that VR significantly reduced PTSD symptoms compared to traditional CBT methods, highlighting VR's potential as a ...

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VR Therapy Careers: Virtual Reality Mental Health 2025 Research shows 60–90% success rates for VR-based exposure therapy for specific phobias, though results vary by condition and patient. To work in ...

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Virtual reality in adolescent mental health management ... The results revealed that the participants' emotional regulation skills improved and their levels of stress and anxiety decreased. Lindner (2021) ...