In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behavior therapy (CBT) to people suffering from schizophrenia and other mental illnesses . The FDA’s devices breakthrough device program is for medical device-led combination products that provide more effective treatment or diagnosis of diseases. The aim of the program is to expedite the development, assessment and review of medical devices in order to provide timely access to patients and healthcare providers.
According to GlobalData’s Epidemiology & Market Size database, around 1.2 million people in the UK and 2.7 million people in the US are believed to suffer from schizophrenia, with schizophrenia spectrum disorders considered to be among the most debilitating of mental illnesses. Schizophrenia is often treated using CBT, but depending on the severity of the disorder, people are also prescribed anti-psychotics to minimise delusions and hallucinations. Anti-psychotics come with the risk of side effects such as drowsiness, agitation and blurred vision, so virtual reality (VR) technologies that can enhance recovery without anti-psychotics are an attractive option.
OxfordVR uses VR headsets to simulate real-world everyday scenarios for patients that are often associated with increased anxiety and stress. The VR headsets offer a virtual coach that guides the patient through the scenarios using CBT methods. This service—which is prescribed—lasts six weeks and the lessons learned during the VR experiences are thought to translate to everyday life.
Clinical trials of gameChangerVR have been run with both the National Health Service (NHS) and the US veteran’s charity Wounded Warrior Project. Within the NHS study, 346 patients with a clinical diagnosis of a schizophrenia spectrum disorder or an affective disorder with psychotic systems were recruited for the study, which found evidence that VR therapy reduced anxious avoidance and distress in everyday situations. In 2020, OxfordVR secured a $12.5m Series A funding from Optum Ventures, supported by Luminous Ventures. The investment helped increase the growth of the company’s immersive VR therapy and was, at the time, the largest investment funding for VR in the UK and Europe. This follows a 2018 project supported by a £4m ($5.7m) grant by the UK National Institute for Health Research (NIHR), which saw OxfordVR’s technology implemented in the NHS.
As well as OxfordVR, other companies have been experimenting with VR to treat mental illnesses and disorders. XRHealth launched a VR therapy application in 2020 designed to treat attention deficit hyperactivity disorder (ADHD). Patients receive a VR headset that offers video calls and in-app messaging with an XRHealth clinician who works with the patient to create a personalized care plan. And last year, EaseVRx received marketing authorisation from the FDA to use VR-based CBT and other behavioral methods to combat pain perception in diagnosed with chronic lower back pain.
The effect on mental health caused by Covid-19, the Russia-Ukraine conflict and other global crises has been significant and has led to greater demand for mental health services due to heightened levels of stress and anxiety. This has led to accelerated innovation within digital health as patients and physicians look for alternatives to in-person care. As well as this, the influx of cases on the strained health services during the pandemic is driving the development of emerging technologies such as VR care to relieve pressure.
GlobalData forecasts that digital health will continue to benefit from collaborations and investments, and that trends in increased use of digital health innovations in neurology and mental health such as telemental health and digital therapeutics will continue post-Covid. In addition, as VR headsets and smart glasses become cheaper, and as VR applications become more accessible on smartphones, digital health technology focusing on VR has become more mainstream. Treatment delivered this way is cost-effective and less time-consuming for both physicians and patients compared with pharmacological interventions. VR treatments can also retain the engaging elements of therapy due to the immersive experience they provide.