OxfordVR Earns FDA’s Breakthrough Device Designation for its gameChange Treatment
Published in Lancet Psychiatry an automated virtual reality therapy program to treat agoraphobic avoidance and distress in patients with psychosis: a multicenter, parallel-group, single-blind, randomized, controlled trial in England was granted FDA’s Breakthrough Device Designation.
Oxford VR develops clinically validated, cost-effective, user-centred cognitive treatments for clinical conditions with significant impact on patients and the healthcare system.
Oxford VR’s developers are drawn from the gaming industry. They apply their animation, illustration and programming skills to help ensure the treatments are not only effective, but also engaging and easy to use. Each VR treatment uses high-quality simulations that promote the best clinical experience.
The clinical study assessed automated virtual reality therapy to treat agoraphobic avoidance and distress in patients with psychosis. It was a parallel-group, single-blind, randomized, controlled trial across nine National Health Service trusts in England. Eligible patients were aged 16 years or older, with a clinical diagnosis of a schizophrenia spectrum disorder or an affective diagnosis with psychotic symptoms, and had self-reported difficulties going outside due to anxiety. Patients were randomly assigned (1:1) to either gameChange VR therapy plus usual care or usual care alone. gameChange VR therapy was provided in approximately six sessions over 6 weeks. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 6 (primary endpoint), and 26 weeks after randomization. The primary outcome was avoidance of, and distress in, everyday situations, assessed using the self-reported Oxford Agoraphobic Avoidance Scale (O-AS).
A total of 346 were enrolled. 231 (67%) patients were men and 111 (32%) were women, 294 (85%) were White, and the mean age was 37·2 years (SD 12·5). 174 patients were randomly assigned to the gameChange VR therapy group and 172 to the usual care alone group. Compared with the usual care alone group, the gameChange VR therapy group had significant reductions in agoraphobic avoidance at 6 weeks.
Reductions in threat cognitions and within-situation defense behaviors mediated treatment outcomes. The greater the severity of anxious fears and avoidance, the greater the treatment benefits. There was no significant difference in the occurrence of serious adverse events between the gameChange VR therapy group (12 events in nine patients) and the usual care alone group (eight events in seven patients; p=0·37).
Automated VR therapy led to significant reductions in anxious avoidance of, and distress in, everyday situations compared with usual care alone. gameChange VR therapy has the potential to increase the provision of effective psychological therapy for psychosis, particularly for patients who find it difficult to leave their home, visit local amenities, or use public transport.
Freeman D, Lambe S, Kabir T, et al. Automated virtual reality therapy to treat agoraphobic avoidance and distress in patients with psychosis (gameChange): a multicentre, parallel-group, single-blind, randomised, controlled trial in England with mediation and moderation analyses. Lancet Psychiatry 2022; 9: 375–88.Published Online. April 5, 2022. https://doi.org/10.1016/ S2215-0366(22)00060-8