Tackling serious mental illness with virtual reality, OxfordVR earns FDA’s groundbreaking device designation for its gameChange treatment

gameChange is a prescription, automated virtual reality cognitive therapy treatment intended to reduce fearful avoidance and anxiety in everyday situations, reduce paranoia, and improve quality of life for individuals (18+ years old) with schizophrenia spectrum disorders or an affective diagnosis with psychotic symptoms, who have difficulty going outside due to anxiety, preventing them from living a normal life, including going out in public.

The National Institute of Mental Health estimate that ~5.6% of adults in the United States (14.2 million) suffer from a severe mental illness (SMI). Of these, ~40% suffer from schizophrenia spectrum disorders and affective disorders with psychotic symptoms† These conditions are irreversibly debilitating and are associated with early morbidity. The total additional costs of schizophrenia only in the US was estimated at $281.6 billion in the year 2020.

The FDA maintains breakthrough status for new technologies that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions, giving patients and healthcare providers faster access to these innovative treatments. gameChange has the potential to help many patients get better care faster, without relying on access to 1:1 therapy.

“Severe mental illness is a huge problem that cannot be solved with existing approaches alone. It is a huge victory for patients and the mental health industry that the FDA recognizes that this technology has the potential to be a more effective way to treat people.” with some of the most challenging mental illnesses,” said Deepak Gopalakrishna, CEO and co-founder of OxfordVR.

Schizophrenia spectrum disorders and affective disorders with psychotic symptoms are characterized by periods of psychosis in which individuals lose touch with reality and may have difficulty understanding what is real and what is not. many individuals struggle with a debilitating fear of being outdoors in everyday situations, and are very interested in treatment. CBT is the most effective treatment for these challenges, but access to this psychological treatment is hampered by the shortage of clinicians. gameChange resolves that impasse by building in virtual therapist therapy, enabling a variety of psychiatric staff and peer counselors to support patient treatment, reducing the need for trained therapists, and creating scalability. In addition, patients can use the treatment in the comfort of their own home, or at their local mental health clinic.

OxfordVR’s platform delivers fully automated CBT in safe, immersive, virtual scenarios that guide patients through simulations of everyday situations: a cafe, shop, pub, street, doctor’s office and a bus. With the virtual reality application, OxfordVR can affordably scale gold standard treatments such as CBT and improve patients’ quality of life in just six weeks. A standard course of CBT, on the other hand, lasts 16 weeks.

Patients participating in the recent clinical trial, who validated the gameChange treatment reported high levels of satisfaction, increased confidence, reduced anxiety and worry, and the ability to engage in activities previously unimaginable. The study showed that the more severe the patients’ fears, the more impact the gameChange treatment had.

“The gameChange study showed that immersive therapies can really help people with severe mental illness, in addition to existing uses such as mild anxiety or insomnia. The most severe patients in our study saw a 49% reduction in avoidance, a 41% reduction in paranoia and a % increase in quality of life after receiving just 3 hours of gameChange VR for 6 weeks, with benefits maintained 6 months after treatment,” said Gopalakrishna.

One participant in the trial said, “gameChange therapy has changed my life. I have more confidence in myself. I have more confidence around other people. I see gameChange helping everyone. I think everyone will start using it.” Another participant said: “If someone has the opportunity to do the virtual reality treatment I would really recommend it because it has meant a lot to me. After seven years of illness I feel so much better. I have been able to do more making eye contact with people without feeling really anxious I can walk down the street without worrying about anyone coming up to me I can now enter a cafe I feel much more confident going on a bus I I just feel so much more confident than I was.”

The FDA designation opens the door to wider use of virtual reality technology in mental health and is part of a growing wave of regulatory and industry support for the digital therapies to play a critical role in solving the problem. current mental health crisis. This seismic shift is also reflected in recent policy changes. At the federal level, support for digital therapies is evident in the shift in approach of the Centers for Medicare and Medicaid, whose recent Announcement points the way to future reimbursement of these treatments.

“With the breakthrough support from the FDA, gameChange will lead a transformation in the digital delivery of evidence-based psychological therapy for some of the most challenging mental health problems, with massive commitment to treatments that really work,” said OxfordVR Scientific Co-Founder , Professor Daniel Freeman (principal investigator, Department of Psychiatry, University of Oxford

OxfordVR partners with leading hospitals and mental health institutions in the US and UK to help improve the quality of life for patients with severe mental illness, including the National Health System (NHS) in the UK

About OxfordVR

OxfordVR is a digital therapeutics company developing evidence-based immersive treatments using virtual reality for severe mental illness. A spin-out from Oxford Universityour treatments are based on more than 25 years of research by Professor Daniel Freeman from Oxford University† Since its founding in 2017, the company has built a strong foundation of clinical validation through multiple clinical trials and real-world implementations. OxfordVR is committed to improving access to world-class mental health services using immersive technology to automate gold standard treatments such as cognitive behavioral therapy (CBT) without the need to rely on increasingly scarce and expensive clinical resources. www.oxfordvr.co

The gameChange trial of Oxford VR, in partnership with Oxford University and the NHS is the world’s largest-ever trial using virtual reality for mental health. The results were published in The Lancet PsychiatryThe study evaluated the effectiveness of individuals with schizophrenia spectrum and affective disorders with psychotic symptoms who used gameChange at home or in an NHS mental health clinic to reduce intense fear and anxiety associated with everyday situations. For many patients, this fear means not leaving the house, severely disrupting relationships with family and friends, their education and career. The company’s VR program was found to be more effective at reducing anxiety and fear, reducing paranoia and improving quality of life, when given in addition to standard care, than standard care alone.

During the study, the patients who benefited the most were those who found it most difficult to leave the house, and those with the most psychiatric symptoms, such as severe anxiety, depression, delusions and hallucinations. These patients experienced major benefits – for example, being able to engage in activities that they previously thought were unimaginable. These benefits were maintained at the six-month follow-up. Patient feedback showed that the treatment was very popular, with a very high acceptance rate and satisfaction.

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