Addressing Serious Mental Illness with Virtual Reality, OxfordVR Earns FDA's Breakthrough Device Designation for its gameChange Treatment

• OxfordVR's gameChange treats patients suffering from some of the most challenging Serious Mental Illness (SMI) conditions with automated Cognitive Behavioral Therapy
  
  
• Fully automated and scalable, the platform helps solve the clinician shortage with an automated Virtual Therapist, and can be delivered with support from a wide-range of clinical staff and peer group members
  
  
• Validated in a recent clinical trial, gameChange is more effective for patients than standard care alone; patients report a high degree of satisfaction and improvement in their quality of life

AUSTIN, Texas, June 22, 2022 /PRNewswire/ -- OxfordVR announced today that its gameChange™ VR therapy was granted the Breakthrough Device designation by the Federal Drug Administration's Breakthrough Devices Program. OxfordVR's gameChange is the world's first immersive therapeutic for Serious Mental Illness (SMI), delivering automated cognitive behavioral therapy (CBT) in virtual reality for patients with some of the most challenging mental health conditions.

gameChange is a prescription-only automated virtual reality cognitive therapy treatment intended to reduce anxious avoidance and distress in daily 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 difficulties going outside their home due to anxiety, preventing them from living a normal life, including going out in public.

The National Mental Health Institute estimates that ~5.6% of adults in the United States (14.2 million) are suffering serious mental illness (SMI). Of these ~40% suffer from schizophrenia spectrum disorders and affective disorders with psychotic symptoms. These conditions are irreversibly debilitating and associated with early morbidity. The total excess cost of schizophrenia alone in the U.S. was estimated at $281.6 billion in 2020. 

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

"Serious mental illness is an enormous issue that cannot be solved with existing approaches alone. It is a huge win for patients and the mental health industry that the FDA recognizes this technology has the potential to be a more effective way to treat people with some of the most challenging mental health conditions," said Deepak Gopalakrishna, OxfordVR CEO and co-founder.

Schizophrenia spectrum disorders and affective disorders with psychotic symptoms are characterized by periods of psychosis where individuals lose contact with reality and may have difficulty understanding what is real and what is not. Many individuals struggle with debilitating fear of being outside in everyday situations, and are very interested in receiving treatment. CBT is the most effective treatment for these challenges, but access to this psychological treatment is hampered by the shortage of clinicians. gameChange addresses that impasse by embedding therapy in the form of a virtual therapist, allowing a variety of mental health staff and peer counselors to support patient treatment, reducing the need for trained therapists, and creating scalability. Plus, patients can use the treatment in the comfort of their own homes, or at their local mental health clinic.

OxfordVR's platform delivers fully automated CBT inside safe, immersive, virtual scenarios that guide patients through simulations of everyday situations: a café, shop, pub, street, doctor's office, and a bus. The virtual reality application allows OxfordVR to affordably scale gold standard treatments like CBT and improve patient quality of life in just six weeks. A standard course of CBT in comparison takes 16 weeks.

Patients participating in the recent clinical trial, which validated the gameChange treatment, reported a high degree of satisfaction, reporting greater confidence, less anxiety and worry, and the ability to undertake activities that were previously unthinkable. The trial showed that the more severe patients' fears, the more impactful the gameChange treatment.

"The gameChange trial showed immersive therapeutics can really help people with severe mental illness, beyond existing applications such as mild anxiety or insomnia. The most severe patients in our trial saw a 49% reduction in avoidance, a 41% reduction in paranoia and a 21% increase in quality of life after receiving just 3 hours of gameChange VR over 6 weeks, with benefits maintained 6 months post treatment," said Gopalakrishna.

Said one trial participant: "gameChange therapy changed my life. I'm more confident in myself. I'm more confident around other people. I see gameChange helping everyone. I think everyone's going to be using it." Another participant said: "If anyone has the opportunity to do the virtual reality treatment, I really would recommend it because it's made a lot of difference to me. After seven years of illness, I do feel so much better. I've been able to make eye contact with people more, without feeling really anxious, I've been able to walk down a street without worrying about anyone walking towards me. I'm now able to go into a café. I feel much more confident about going on a bus. I just feel so much more confident than I was."

The FDA designation opens the door for broader use of virtual reality technology in mental healthcare and is part of a growing swell of regulatory and industry support for the digital therapeutics to play a pivotal role in solving the current mental healthcare crisis. This seismic shift is mirrored in recent policy changes as well. On the federal level, support for digital therapeutics is evident in the change in approach from the Centers for Medicare and Medicaid, whose recent announcement points the way to future reimbursement of these treatments.

"With the FDA's breakthrough support, gameChange will lead a transformation in the digital provision of evidence-based psychological therapy for some of the most challenging mental health problems, with deployment at scale for treatments that really work," said OxfordVR scientific co-founder, Professor Daniel Freeman (lead researcher, Department of Psychiatry, University of Oxford).

OxfordVR works with leading hospitals and mental healthcare institutions in the U.S. and U.K. to help improve the quality of life for patients with serious mental health conditions including the National Health System (NHS) in the U.K.

OxfordVR is a digital therapeutics company that develops evidence-based immersive treatments using virtual reality for serious mental illness. A spin out of Oxford University, our treatments are built on more than 25 years of research from Professor Daniel Freeman of Oxford University. The company has amassed a strong foundation of clinical validation through multiple clinical trials and real-world deployments since its inception in 2017. OxfordVR is dedicated to improving world class access to mental health using immersive technology to automate gold-standard treatments like cognitive behavioral therapy (CBT) without the need to rely on increasingly scarce and expensive clinical resources. www.oxfordvr.co

Oxford VR's gameChange trial, 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 Psychiatry, The trial evaluated the effectiveness of individuals with schizophrenia spectrum disorders and affective disorders with psychotic symptoms using gameChange at home or in a NHS mental health clinic to reduce intense anxiety and distress associated with everyday situations. For many patients, these fears mean they avoid leaving the home, severely disrupting relationships with family and friends, their education, and careers. The company's VR program was shown to be more effective at improving anxiety and distress, reducing paranoia and improving quality of life, when given alongside standard care, than standard care alone.

During the trial the patients who benefited most significantly were those who found it hardest to leave the house, and those with most psychiatric symptoms, such as severe anxiety, depression, delusions, and hallucinations. These patients experienced large benefits – for example, being able to undertake activities they had previously found unthinkable. These benefits were maintained at the six-month follow-up. Patient feedback showed that the treatment was very popular, with very high up-take rates and satisfaction.

Media Contact
[email protected]

SOURCE OxfordVR