OxfordVR announced that its gameChangeTM VR therapy was granted the Breakthrough Device designation by the Federal Drug Administration’s Breakthrough Devices Programme.
OxfordVR’s gameChange is the world’s first immersive therapeutic for Serious Mental Illness (SMI), delivering automated cognitive behavioural 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 the 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 US (14.2 million) have a 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 cost of schizophrenia alone in the US 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 recognises this technology can 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 characterised 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 a 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 the shortage of clinicians hampers access to this psychological treatment.
gameChange addresses that impasse by embedding therapy in the form of a virtual therapist, allowing a variety of mental health staff and peer counsellors 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 validated the gameChange treatment and reported high satisfaction, greater confidence, less anxiety and worry, and the ability to undertake previously unthinkable activities. The trial showed that the more severe patients’ fears, the more impactful the gameChange treatment.
‘The gameChange trial showed immersive therapeutics could help people with a severe mental illnesses beyond 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 three hours of gameChange VR over six weeks, with benefits maintained six 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 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 anxious, and I’ve been able to walk down a street without worrying about anyone walking toward me. I’m now able to go into a café. I feel much more confident about going on a bus. I feel so much more confident than I was.’
The FDA designation opens the door for broader use of virtual reality technology in mental healthcare. It is part of a growing swell of regulatory and industry support for 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 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 US and UK to help improve the quality of life for patients with serious mental health conditions, including the National Health System (NHS) in the UK.
