UK MHRA approves Lumi Nova – the first game-based digital therapeutic to treat anxiety disorders in children

Lumi Nova MHRA approval.jpg

  • Anxiety levels have more than doubled in young people following COVID-19 lockdown. With children back in schools, children’s mental health will likely be further challenged. 

  • Co-created with NHS clinicians, children, parents, teachers, a BAFTA award-winning game producer, MindTech UK, and the University of Reading’s Anxiety and Depression in Young People (AnDY) Research Unit.

  • Lumi Nova is accessible through NHS children and young people’s mental health services, schools, and local authorities.

Composite image for press release.jpg

LONDON, Sept 02, 2020

BfB Labs, a pioneer in the use of emergent technology for children’s mental health has today announced that it has received regulatory approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Lumi Nova – the first mobile game for paediatric anxiety in children aged 7-12 years.  

Lumi Nova has been funded by NHS England via the NHS Improvement’s SBRI Healthcare programme and developed in partnership with the Anxiety and Depression in Young People (AnDY) Research Clinic at the University of Reading, and MindTech UK. Lumi Nova aims to revolutionise mental health interventions for children helping them to overcome anxiety using an evidence-based therapeutic approach. The intervention combines methodologically rigorous user-centred design and proven immersive therapy the gold standard for treating anxiety, delivered through an engaging mobile game. In a small-scale pilot conducted in March 2020, Lumi Nova demonstrated the highest levels of safety and is a cost-effective way to treat the symptoms of anxiety in real-world settings.

It is estimated that as many as 7 out of 10 children with an anxiety disorder in the UK did not have access to evidence-based treatment, before the onset of COVID-19. Childhood anxiety disorders include generalised anxiety disorder, social anxiety disorder, separation anxiety disorder, panic disorder, and phobias. Anxiety can have a huge impact on young people’s lives, which can include difficulties with school attendance, socialising, and participating in daily activities.  Anxiety disorders are associated with substantial disability and longer-term mental health consequences. 

With children back in schools and the negative psychological consequences of the COVID-19 crisis continuing to unravel, Lumi Nova provides an accessible and scalable intervention for anxiety for NHS Integrated Care Systems and Clinical Commissioning Groups, schools, and local authorities. 

We must act urgently to mobilise evidence-based interventions to tackle anxiety in our most vulnerable children and young people at this extraordinary time of crisis and particularly now that schools have reopened,” said Dr Claire Hill, Clinical Psychologist & Postdoctoral Researcher at The University of Reading. “Untreated anxiety can lead to depression, self-harm, and other life-long consequences. Lumi Nova is an engaging game that has demonstrated safety and is an important exemplar as the first MHRA approved mobile game for paediatric anxiety that gamifies exposure – the key component of CBT, the gold standard for treating anxiety - and should be considered for implementation by schools, local authorities and in routine clinical care."

BfB Labs combines scientific and clinical rigour with the ingenuity of emergent technology and games to challenge the status quo in mental health interventions for children.  BfB Labs has pioneered the development of video game-based digital intervention to improve emotional regulation and now anxiety in children. Authorised professionals can track detailed intervention progress analytics through BfB Labs’ hub - a secure online portal. 

At BfB Labs, we are committed to building future mental healthcare for children today with evidence-based interventions that are not only accessible and affordable but also treat conditions in an entirely new and engaging way,” said Manjul Rathee, CEO of BfB Labs. “During this time of urgent need for digital mental health solutions that can respond to soaring demand, we are extremely proud to enable NHS Integrated Care Systems and Clinical Commissioning Groups, schools, and local authorities to provide Lumi Nova - a safe, flexible, and cost-effective solution.”

-ENDS-

 

About BfB Labs

  • Founded in 2015, BfB Labs has pioneered the development of video game-based digital therapies for children using proven cognitive behavioural therapy (CBT) techniques to improve emotional regulation and resilience and now anxiety disorders. 

  • BfB Labs combine scientific and clinical rigour with the ingenuity of emergent technology and games to democratise access to evidence-based children’s mental health interventions.  

  • Lumi Nova has been funded by NHS England and NHS Improvement’s SBRI Healthcare programme.

  • Driven by BfB Labs’ belief that effective interventions should be co-created with users, the people that care for them, and should also be highly engaging and clinically effective.

  • BfB Labs treatments are delivered through an immersive mobile game experience to drive user engagement and compliance. 

  • BfB Labs flagship products include Lumi Nova and Champions of the Shengha, a heart-rate driven biofeedback mobile game that improves emotional self-regulation and resilience skills.  

  • Lumi Nova and Champions of the Shengha meet the highest standards in clinical safety & data security and are both CE marked and approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).

 

About MindTech

  • MindTech is a national centre focusing on the development, adoption, and evaluation of new technologies for mental healthcare and dementia. 

  • Established in 2013 and funded by the National Institute for Healthcare Research to work in partnership with healthcare professionals, patients and the public, researchers, and industry. 

  • MindTech aims to identify the unmet needs of patients, families, and professionals, to collaborate on developing and testing of new technologies, and to work with NHS organisations to increase adoption.

 

About NHS England and NHS Improvement's SBRI Healthcare Programme

  • SBRI Healthcare is a cutting-edge programme that supports the development of new innovations which meet known NHS challenges. The Small Business Research Initiative for Healthcare (SBRI) programme runs competitions for innovations identified as an unmet need.

  • This demand-led approach enables industry to respond directly to healthcare challenges and feeds the innovation pipeline with products that have an existing demand from the NHS. This allows for faster adoption and spread of these products benefiting patients.

  • The aim of the programme is to:

    • improve patient care

    • enable the NHS to access new innovations through research and development that solve identified healthcare challenges and unmet need

    • increase value for the NHS

    • bring economic value and wealth creation opportunity to the UK economy


1 Early data from University of Bristol study, June 2020

2 European child & adolescent psychiatry vol. 27,8 (2018): 1023-1031. Reardon, Tessa et al.

3 The Lancet, Global Health Metrics, A systematic analysis for the Global Burden of Disease Study 2017, Vol 392, Issue 10159 (2018), Spencer L James et al.

Previous
Previous

World Mental Health Day 2020 Infographic - The shadow pandemic - children’s mental health