A UK startup has been awarded Breakthrough Device Designation for a prescription-based software product using virtual reality to treat patients with severe mental illness.
The FDA designation should help expedite adoption of the therapy, which is Oxford VRsaid Deepak Gopalakrishna, CEO and co-founder of the company.
He attributes the name in part to a recent clinical trial that demonstrated the therapy’s effectiveness, called gameChange. Published in The Lancet Psychiatry in Aprilthe trial results showed that gameChange had an impact over six weeks of treatment on people who had previously been too anxious to go to the store, take the bus or even leave home.
The product also brings other potential benefits, Gopalakrishna said. It could reduce costs and expand access to relatively expensive patients with severe mental illness, Gopalakrishna said in an interview. They make up about 5.6 percent of the U.S. population, according to the National Institute of Mental Health.
“There aren’t enough trained therapists to meet the needs of people who need this kind of care,” he said.
Other digital health startups are grappling with a shortage of mental health professionals and finding new ways to deliver care. They include BetterHelp, Limbix Health, Octave and Spring Health. The latter recently published research Showcasing its workplace-based program that uses machine learning to customize care, saving employers money.
In the trial, Oxford VR studied the effect of gameChange on 346 patients. About half use VR products in conjunction with their daily care, while the other half only receive daily care. The most severe patients saw a 49 percent reduction in avoidance behavior, a 41 percent reduction in paranoia, and a 21 percent improvement in quality of life after six weeks of care.
The study’s authors include Daniel Freeman, professor of psychology at Oxford University and co-founder of Oxford VR. His research supports the gameChange software.
The research on gameChange seems promising, said John Toros, director of digital psychiatry at Beth Israel Deaconess Medical Center in Boston, which is affiliated with Harvard Medical School. Overall, the challenges of digital mental health have scaled from small studies to widespread implementation, he said.
Vendors may have difficulty integrating new technologies into existing workflows or lack the skills needed to make them work, he said in a phone interview.
“Do you need VR experts on staff to help people use it, or can existing staff manage it?” he asked to point out possible issues with vendors adopting the technology.
When it comes to Oxford VR, that would be a no. Gopalakrishna said Oxford VR tries to make gameChange as simple as possible for patients and providers who oversee its use. Therefore, no VR-trained experts are required, and users do not need any additional technical training.
The company does provide training and technical support to clinic staff to help them get started, he said. Training includes how to help patients translate their VR experience into the real world.
“Drag and drop is really easy for us,” says Gopalakrishna.
In traditional cognitive-behavioral therapy approaches, the therapist might take the patient to the outside world, Gopalakrisha said. If and when they encounter a situation that triggers anxiety, the therapist provides guidance to lessen the effect.
“That leaves a lot of opportunity,” Gopalakrishna said. It’s also expensive because therapists can spend months with individual patients.
Instead, gameChange recreates stressful situations and guides patients in virtual reality with the help of an automated therapist. Even when patients are in virtual reality, they perceive these situations as real, Gopalakrishna said. The software can run on any commercially available VR headset.
The goal, Gopalakrishna said, is not to replace therapists, but to expand their ability to treat patients. For example, instead of seeing a therapist every week, a patient could rotate between a therapist and gameChange on a weekly basis, potentially doubling the therapist’s capacity.
Backed by trial results and FDA approval, Oxford VR has been rolling out gameChange in clinics run by the National Health Service and at providers in the U.S. Gopalakrishna declined to identify them.
In the UK, Oxford VR’s fees come from any savings from using gameChange, Gopalakrishna said. The company operates in the U.S. with a variety of payment models, but expects to be reimbursed primarily from bundled payments to providers to care for patients.
Most patients use gameChange in a clinical setting.However, the product is available for home use under one plan Wounded Warrior Projecta nonprofit focused on U.S. veterans who have suffered physical injury or mental illness.
Founded in 2017, Oxford VR raised $12.5 million in a Series A round in February 2020. Investors include Optum Ventures, Luminous Ventures, Oxford Sciences Innovation, Oxford University Innovation and GT Healthcare Capital Partners.
The company also offers a VR product designed to help patients overcome anxious social avoidance.
