Monthly Archives: June 2022

Using Virtual Reality to Address Serious Mental Illness

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 Study

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).

Results

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.

Sources:

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 

OxfordVR website

GamechangeVR website


AIfred Health Begins North American Clinical Trial of AI-based Clinical Decision Support Tool for MDD

This clinical trial, a world-first in the treatment of mental health using an AI-based clinical decision support tool, was designed with input from US and Canadian regulatory authorities to validate Aifred’s AI platform for use with patients suffering from moderate to severe depression.  

Aifred’s technology was developed using high quality clinical data from clinical trials evaluating therapeutic treatments of depression. Aifred’s software was developed with and for treating physicians (family doctors and psychiatrists) who today have limited tools to personalize the therapeutic choice for patients, leading to what is for many patients a lengthy and painful trial-and-error process. Aifred’s software is intended to support clinical decision making and improve this experience for patients and clinicians alike.

The trial is being conducted at up to 12 U.S. and Canadian centers of excellence for depression treatment including Veterans Affairs (VA) hospitals where Aifred is a VA research partner. Aifred expects to complete enrollment in 2022 and report top-line results in mid 2023. Aifred’s technology placed #1 in North America and #2 in the world in the IBM Watson AI XPRIZE, the goal is to initiate and complete this clinical trial which will provide clinicians across North America with a much-needed clinical tool. 

Aifred’s current patient <> physician clinical decision support tool is accessible on any device, supporting both telehealth and in-person appointments. A patient enters behavioral health information, which is then processed by a clinical algorithm based on best-evidence guidelines. Outputs help the physician understand: where the patient is on the disease cycle, monitor the patient over time, and determine ‘what to do next’ at each stage, e.g. adding psychotherapy or making adjustments to medication.

For additional information about this landmark clinical trial can consult: https://clinicaltrials.gov/ct2/show/NCT04655924  

Source: Aifred Health Website

Video of interviews by XPRIZE Foundation of unscripted comments by medical professionals working with Aifred [Link]

NICE’s Early Value Assessment for Medtech

The explosion in digital health products has left National Health Service commissioners in the UK wondering how they can possibly sift out what works and what provides maximum benefit for the service and for patients.

The Early Value Assessment for Medtech will offer a rapid assessment of digital products, devices and diagnostics for clinical effectiveness and value for money. The goal of this new approach is that the service and patients will be able to benefit sooner.

Early Value Assessment is being designed to draw in the most promising and impactful medical technologies where the evidence base is still emerging, starting with digital products, in areas where there is greatest need.  Whether its empowering patients to better manage their own health and seek clinical advice, reducing admissions and waiting lists or supporting clinicians and other front-line staff to provide better quality care this new program will help to alleviate system pressures as the NHS recovers from the COVID pandemic.

In this accelerated approach, the first two pilot digital health topics will begin their early value assessments this month (June) with a view to publishing findings in October. This is much faster than a full NICE Medtech evaluation meaning benefits will be realized sooner, while companies generate more evidence required for a full NICE evaluation at a later stage.  

The first two pilots are digital apps for depression and anxiety in children and others will quickly follow in adult mental health, early cancer diagnosis, cardiovascular disease and other areas that support elective recovery following the pandemic.

In this ‘fast-track’ approach, NICE is working closely with NHS England and all its system partners to help develop commercial and data collection arrangements to support the technologies that go through early value assessment in adoption and scaling and to make this new program of work deliver on the potential of digital health for patients.

Source: NHS Blog