Product Highlight
Condition targeted:
Agoraphobic avoidance and distress
How it works:
gameChange is a self-guided digital therapeutic that uses Virtual Reality (VR) to deliver cognitive-behavioral therapy (CBT)
Impact:
Use of gameChange for 6 weeks leads to sustained reductions in the agoraphobic avoidane of everyday situations and in distress
Product Overview
Medical condition:
Agoraphobic avoidance and distress
Target patient population:
Individuals with psychosis aged 16 and over who have difficulties participating in everyday activities due to intense anxiety and are willing to feel more confident in social situations
What to expect:
Reduction in levels of agoraphobic avoidance and distress, paranoia, and quality of life
Note: for more information, please visit https://www.realizedcare.com/agoraphobic-avoidance
Clinical Overview
Indications for use:
gameChange is currently recommended for use in the NHS (UK), while more evidence is generated, to treat severe agoraphobic avoidance in people with psychosis with the support of a mental health professional.
Outcomes:
A clinical trial with 346 patients with psychosis demonstrated that use of gameChange during 6 weeks led to moderate-large sutained reductions in avoidance (49%), distress (19%), and paranoia symptoms (41%), and an improvement of quality of life (21%) in the severe population.
Directions:
gameChange comprises several automated VR-therapy sessions intended to deliver CBT to target anxiety about everyday social situations. gameChange is designed to be delivered in approximately 6 sessions, each involving 20-30 minutes in VR. gameChange recommends patients complete at least one session, consisting of all 5 levels of a single scenario, per week for 6 or more weeks. Each VR therapy module is comprised of a CBT component delivered by a virtual coach within the VR program, and is intended to take ~5 minutes to complete. gameChange does not require direct involvement by a prescribing physician or a healthcare professional during use of the product.
Risks & warnings:
Use of gameChange is not recommended for people with photosensitive epilepsy. Use with caution is advised for people with a lack of stereoscopic vision or balance problems.
Place in therapy:
Intended as a standalone or in conjunction with medication and therapy
Product Access
Product description:
gameChange is designed to be used with commercially available VR headsets supporting six degrees of freedom tracking.
Prescription status:
No prescription is required
Patient access:
Patients receive a VR kit shipped home (or pickedup from a doctors office/store) with gameChange set-up and ready to be used.
Use of this product requires access to:
- a Virtual Reality headset (provided)
- a wifi connection
Provider access:
Providers do not have access to patient outcomes through a portal or report. GameChange does not collect individual patient data. gameChange can be currently used in England NHS while real-world evidence is generated and with the support of a mental health professional.
Coverage options:
Currently gameChange is sold via a public payer model via the NHS. However, independent providers in the UK can purchase independently. gameChange is not sold or offered direct to patients / consumers.
Product availability:
gameChaneg is available in:
- UK: class I CE mark
Unique Features.
gameChange effectiveness and safety was demonstrated in the largest ever clincal trial of VR for mental health (346 patients across nine NHS Trusts)
Clinical Trials
The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.
- Study Title: 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
Study Design: multi-site, parallel-group, single-blind, randomized controlled trial, comparing gameChange vs treatment-as-usual (n = 346)
Outcomes: Significant reductions in agoraphobic avoidance and distress at 6 and 26 weeks after VR therapy (Moderate-Large effects: d’=0.5-0.79 for severe patients) - Study Title: Estimating the Economic Value of Automated Virtual Reality Cognitive Therapy for Treating Agoraphobic Avoidance in Patients With Psychosis: Findings From the gameChange Randomized Controlled Clinical Trial
Study Design: Health Economics Outcome Research that estimated the economic value of gameChange for the UK National Health Service (NHS) and determined the maximum cost-effective price per patient.
Outcomes: Subjects that received gameChange reported higher quality-adjusted life years and lower NHS and social care costs compared with treatment as usual - Study Title: A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy
Study Design: Qualitative research with 20 people with a diagnosis of psychosis who received gameChange as part of a clinical trial
Outcomes: Most severe patients reported “big changes” from the gameChange VR therapy - Study Title: Automated Virtual Reality Cognitive Therapy (gameChange) in Inpatient Psychiatric Wards: Qualitative Study of Staff and Patient Views Using an Implementation Framework
Study Design: Qualitatitive research exploring the views of patients (n=19) and staff (n=22) on gameChange in psychiatric inpatient units
Outcomes: Patients and staff were keen to use gameChange and viewed its implementation feasible with few significant barriers.
Note: for more research, please visit https://www.realizedcare.com/agoraphobic-avoidance