Title: Immersive virtual reality to transform the lives of patients with psychosis
Funder: Department of Health and Social Care

Abstract: Problem: Almost all patients with schizophrenia get anxious and mistrustful. They often hear threatening voices. Their self-confidence is greatly reduced. Understandably, patients often find it frightening or difficult to be outside among people. They tend to withdraw from activities, and this isolation and inactivity leads to a cycle of worsening physical and mental health. Breaking this cycle requires treatment that enables patients to learn that they can safely and confidently enter everyday situations. But there are too few clinicians to do this vital work. Solution: Immersive virtual reality, combined with psychological science, can solve this major clinical issue. Within VR social situations we can now coach patients in how to overcome difficulties. The situations are graded for difficulty and personalised. Learning in VR transfers to the real world. Our VR treatments are delivered with affordable consumer equipment. Data: Our group pioneered the use of VR for psychosis (Freeman et al, 2003). Our recent randomised controlled test with 30 patients showed that just one session of our VR cognitive treatment produces large reductions in persecutory delusions (d=1.3) compared to VR exposure treatment (Freeman et al, 2016). Our treatment leads to large reductions in distress in real-world situations (d=0.8). Patients reported that VR enabled them to go back into situations they had avoided for years. These are unprecedented effect sizes in psychosis when comparing active treatments. We have an MRC award that has funded the treatment to be lengthened, automated, and tested with a further 90 patients. Hypotheses: 1. VR can be a highly engaging, popular, and feasible treatment in psychosis services, thereby radically increasing access to psychological therapy. 2. The VR treatment leads to greater recovery in psychiatric symptoms, higher activity levels, and better quality of life compared to current practice. 3. There is a strong commissioning case for the use of VR in NHS psychosis services. Method: The Royal College of Art Healthcare Research Space, working with the McPin Foundation, will use a Double Diamond process to greatly enhance the user experience of the treatment (Workpackage 1). Contextual issues concerning NHS implementation will be addressed by clinical adoption studies led by NIHR MindTech HTC (Workpackage 2). MindTech, collaborating with the McPin Foundation, will conduct a formal evaluation, focussing on factors affecting engagement, clinician training, and impact on the psychosis care pathway. A VR implementation toolkit will be produced. We will then carry out a multi-centre (Bristol, Manchester, Newcastle, Nottingham, Oxford) trial. 432 patients attending psychosis services and having difficulties going outside will be randomised to the six-hour VR treatment added to standard care or standard care (Workpackage 3). Blind assessments will be conducted at 0, 6 (post treatment), and 26 weeks. The primary outcome is activity, with movement data recorded objectively by actigraphy. The secondary outcomes are psychiatric symptoms (paranoia, anxiety, depression, suicidal ideation), psychological well-being, and quality of life. 432 participants will provide 90% power to detect a standardised effect size of 0.35, at 5% level of significance and allowing for 20% attrition. An economic evaluation, adopting a health and social care perspective, will assess cost-effectiveness, and feed into the development of the value proposition and commissioning case (Workpackage 4). This will be led by MindTech. Commercialisation will be conducted in partnership with Nowican (Oxford VR) (www.nowican.com), a new University of Oxford spin-out supported by Oxford Sciences Innovation, which draws investment from funders such as the Wellcome Trust, Google Ventures, and the university. Outcome: A proven, highly efficacious, and highly engaging VR treatment system for patients with psychosis, with a commissioning rationale for sustainable NHS adoption and a commercial strategy, that can transform NHS mental health care.

Lay abstract: Why is the research important? Many people with psychosis find social situations difficult and consequently withdraw from everyday activities. Isolation and lack of activity mean that people often develop physical health problems and their mental health deteriorates. Currently only 5% of people with psychosis receive psychological therapy, and that therapy seldom directly addresses social withdrawal. This study uses cutting-edge Virtual Reality (VR) technology. VR enables people to practise skills in a computer-simulated world to reduce problems in real life. This innovative approach reduces anxiety and paranoia and improves engagement in everyday activities. How will the research be carried out? VR therapy involves wearing a headset and interacting with computer-generated people. Uniquely in our VR therapy, a virtual coach guides the user through their thoughts, feelings, and responses in social situations. Designers, people with psychosis, and NHS staff will work together to develop the VR therapy to ensure the best user experience. A further consultation process will produce a guide to using VR in NHS psychosis services. To test the effectiveness of VR therapy, 432 people with psychosis will take part in a clinical trial. Half of the participants will receive their usual treatment, and half will also receive six sessions of VR therapy. Participants physical activity levels, symptoms, and quality of life before and after treatment will be assessed. The team will also analyse the treatment cost-effectiveness, and produce a commissioning case for the widespread NHS use of VR therapy. How could the research affect health care? This technology will radically improve treatment for psychosis. Because the treatment is automated, many more patients will have access to effective psychological treatment. The cost of VR therapy is a fraction of that for standard therapies. It also potentially cuts overall treatment costs by improving health and reducing time spent in hospital.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH