gameChangeVR (a virtual reality [VR] technology) can be used in the NHS while more evidence is generated, to treat severe agoraphobic avoidance in people with psychosis aged 16 and over. It should be used with the support of a mental health professional.
The company must confirm that agreements are in place to generate the evidence (as outlined in NICE's evidence generation plan) and contact NICE annually to confirm that evidence is being generated and analysed as planned. NICE may withdraw the guidance if these conditions are not met.
At the end of the evidence generation period (3 years, or sooner if enough evidence is available), the company should submit the evidence to NICE in a form that can be used for decision making. NICE will review the evidence and assess if the technology can be routinely adopted in the NHS.
More research is needed on the following VR technologies:
Amelia Virtual Care to treat agoraphobia
gameChangeVR to treat mild to moderate agoraphobic avoidance in people with psychosis
XR Therapeutics to treat agoraphobia.
Access to the technologies for the indications in section 1.4 should be through company, research, or non-core NHS funding, and clinical and financial risks should be appropriately managed.
The technologies can only be used once they have appropriate regulatory approval.
More evidence generation and research are needed on:
clinical effectiveness, including long-term benefits and who may benefit most from using VR technologies
rates of relapse or worsening of symptoms, including use and effectiveness of extra VR therapy sessions
adverse effects
resource use, including maintenance and lifespan of the hardware, and mental health professional grade and time needed to deliver treatment or support.
Potential benefits of using gameChangeVR in the NHS with evidence generation
Unmet need: Agoraphobia is often untreated or undertreated, especially when its symptoms occur with other mental health conditions, such as agoraphobic avoidance in people with psychosis. Access to psychological interventions such as cognitive behavioural therapy (CBT) for treating psychosis varies and is very limited for some people. gameChangeVR is a virtual reality (VR) technology that delivers VR therapy using CBT techniques. It offers a treatment option for people aged 16 and over, who have psychosis and severe agoraphobic avoidance, who may otherwise not have psychological treatment.
Clinical benefit: The clinical evidence suggests that gameChangeVR has potential benefits for treating severe agoraphobic avoidance in people with psychosis.
Resources: gameChangeVR can be delivered and supported by mental health professionals working in lower pay bands than staff who are delivering other psychological treatments for psychosis with agoraphobic avoidance. gameChangeVR may also need less mental health professional time for delivery and support than other psychological treatments.
Managing the risk of using gameChangeVR in the NHS with evidence generation
Clinical assessment: gameChangeVR should only be offered after assessing and identifying severe agoraphobic avoidance in people with psychosis. People with psychosis who are having difficulty leaving the house should be assessed in line with the World Health Organization's International Classification of Diseases (ICD)-10 classification of agoraphobia. Mental health professionals may use assessment tools to help identify the presence and severity of agoraphobic avoidance. They should also assess a person's safety, and if VR therapy is suitable for them.
Evidence generation: There are uncertainties about the clinical and cost effectiveness of gameChangeVR for treating agoraphobic avoidance in people with psychosis because of the limited evidence. There is only 1 key effectiveness study for the technology. A secondary analysis on gameChangeVR suggests that there are benefits in treating agoraphobic avoidance in people with psychosis, but only when the agoraphobic avoidance is severe. Primary evidence is needed to confirm this finding.
Costs: Cost modelling suggests that gameChangeVR may be cost effective in people with psychosis who have severe agoraphobic avoidance, but there is considerable decision uncertainty in the modelling. gameChangeVR is unlikely to be cost effective for treating mild to moderate agoraphobic avoidance in people with psychosis.
Equality: VR technologies may not be accessible to everyone. Additional support and resources may be needed for people who are unfamiliar with digital technologies or who do not have access to the internet. Other treatment options may be more appropriate for some people with agoraphobic avoidance. Everyone has the right to make informed decisions about their care.
The evidence generation plan gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources. It includes how the evidence gaps could be resolved through real-world evidence studies.