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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Virtual Reality Therapy for mental health?

Research shows that virtual reality (VR) therapy can help reduce anxiety and avoidance in people with psychosis and has shown promise in treating anxiety disorders, eating disorders, and other mental health conditions. VR therapy is effective in providing psychological treatments, especially for those who have limited access to traditional therapy. ^{1 2 3 4 5}

Is virtual reality therapy safe for mental health treatment?

Virtual reality therapy is generally safe for treating mental health conditions like anxiety disorders, though it can cause mild and temporary side effects such as nausea, dizziness, or headache. ^{6 7 8 9 10}

How is virtual reality therapy different from other mental health treatments?

Virtual reality therapy is unique because it uses immersive, computer-generated environments to simulate real-life activities, which can help patients engage with their treatment in a more interactive and controlled way. This approach can be more cost-effective and accessible, offering new techniques like embodiment and self-led interventions that traditional therapies may not provide. ^{9 11 12 13 14}

What is the purpose of this trial?

The goal is to explore the use of Virtual Reality (VR) as an intervention to increase self-efficacy in a healthcare setting. The investigators would like to determine if an educational VR intervention in the course of healthcare could increase pediatric patient self-efficacy compared to standard of care (i.e no VR).

Eligibility Criteria

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

My health condition is not stable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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) 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 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) 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]

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]

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]

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) 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]

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]

References

1. Hungary pubmed.ncbi.nlm.nih.gov

[Virtual Reality in psychiatry and psychotherapy]. [2021]

2. Canada 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. [2020]

3. Canada 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. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. [2023]

5. Canada 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. [2023]

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

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

7. Greece pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in anxiety disorders]. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

[VR-supported therapy for anxiety and posttraumatic stress disorder: current possibilities and limitations]. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Clinical Research: Promises and Challenges. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Virtual reality for treatment compliance for people with serious mental illness. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Virtual reality in mental health : a review of the literature. [2022]

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

Virtual reality: using the virtual world to improve quality of life in the real world. [2019]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Advances in immersive virtual reality interventions for mental disorders: A new reality? [2021]