Lumi Nova: Instructions for use
Please read this instruction manual thoroughly before using the Lumi Nova app. Please keep these instructions for future reference.
Product Outline
Product Details
Lumi Nova: Tales of Courage is a digital therapeutic that helps with the symptoms of worries or anxiety for children aged 7-12 years with mild to moderate needs, helping them learn skills to self-manage their worries/anxiety in an engaging intergalactic adventure game (app).
This app facilitates CBT (including psychoeducation and exposure therapy) recommended as a treatment intervention by NICE Anxiety disorders Quality standard and the Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the treatment of anxiety disorders.
Lumi Nova: Tales of Courage is a Class 1 software as a medical device as part of the VitaMind offer by BFB Labs.
Product Description
Lumi Nova: Tales of Courage is a digital therapeutic that helps with the symptoms of worries or anxiety for children aged 7-12 years with mild to moderate needs, helping them learn skills to self-manage their worries/anxiety in an engaging intergalactic adventure game (app). The software is accessible via the Google Play store and the iOS store and needs an activation key to be used. The software provides CBT (including psychoeducation and exposure therapy) based on exposure therapy techniques in a gaming environment.
The software collects data against widely accepted outcome measures and enables users to set goals and create graded exposure ladders. The software encourages users to take exposure steps in and out of the software environment. The software will capture user progress data and transmit this securely to the distributor’s portal (secure) known as the VitaMind Hub.
The software is not intended to be used for clinical diagnosis and does not monitor patient vital signs. The software tracks progress of the user through questionnaires and analytics and this information is made available to the organisation(s) purchasing the service, however it is not intended to be used to make clinical decisions.
Instructions for Use
Please read this instruction manual thoroughly before using the Lumi Nova app. Please keep these instructions for future reference.
Intended Use
The software (game) will be used with 7-12 year old children with signs of worries or anxiety determined by a parent, teacher, clinician or wellbeing practitioner.
The offering may be distributed via:
Self sign up via an online registration page hosted by a health, social care or educational organisation
Clinicians in Child Adolescent Mental Health Services (CAMHS) or similar
General Practitioners/Physicians via GP practices
Mental Health Practitioners/professionals carrying out child’s needs assessment
Mental Health Practitioners/professionals in Mental Health Support Teams in schools
Teachers, wellbeing coordinators or SENCOs in schools
Lumi Nova: Tales of Courage therapeutic model
At the start, the game asks the guardian of the child (player) to shortlist 3 goals out of a menu of goals (feared scenarios) that are appropriate to their child.
Based on their answers, the game offers players with 3 goals to choose from. The player chooses a goal (feared scenarios they’d like to work on first).
The goals relate to the most common feared scenarios for this age range (7-12 years). These fall into three anxiety types:
Social Anxiety
Separation Anxiety
Phobias
Each goal is broken down into multiple challenge steps. The game shows the player all of the graded challenges within that goal from least scary to most scary. Some of the challenges are in-game simulations and some are out of game (in-vivo, planned and attempted with Guardian’s support - Guardian is apprised of child’s progress via automated SMS).
The player completes psycho education through immersive storytelling in the game, and starts to attempt their graded challenges. As the player attempts/completes each new challenge, they reflect on how they’re feeling, and earn exciting rewards. This contributes to understanding the process of breaking down fears into graded byte sized challenges, and attempting them to build confidence.
The game comprises the following:
Story based psycho education
Option of goals for most common childhood anxieties (social, separation, phobias)
Thought diary
Voice guided imaginal exposure challenges, interactive multimedia exposure modules, gyroscopic environments
Voice guided real world (in-vivo) challenges
Gamified reward system for attempting and completing challenges
Option to revisit psycho education any time during game play
Option to repeat challenges
Automated SMS alerts to guardian
30-40 minute play time limit per session per day
Automated push notification reminders
Compatible with iOS and Android mobile / tablet devices
Access to ongoing game enhancements and new content
Indications for Use
Lumi Nova: Tales of Courage is a digital therapeutic that helps with the symptoms of worries or anxiety for children aged 7-12 years with mild to moderate needs, helping them learn skills to self-manage their worries/anxiety in an engaging intergalactic adventure game (app).
There are no known misuses of the offering.
Contraindications
Lumi Nova is not intended to be used by:
Young people who do not have parental or carer supervision
Young people who are currently experiencing suicidal thoughts or are at risk of self harm
Young people that have severe anxiety or are in crisis
Young people with severe mental health symptoms or diagnoses, who are not supported by a healthcare professional.
Safety Information
Safety Instructions
This app must be downloaded by a parent/guardian on a mobile device accessible by their child and can be connected to the internet. In the first instance, the parent/guardian is responsible for the supervision of the young person while using Lumi Nova. However, in addition, the young person may also be supported by a nominated healthcare professional.
Lumi Nova: Tales of Courage is contraindicated for the following:
Young people who do not have parent, carer, guardian or trusted adult supervision
Young people who are currently experiencing suicidal thoughts or are at risk of self harm
Young people that have severe anxiety or are in crisis
Young people with severe mental health symptoms or diagnoses, who are not supported by a healthcare professional.
All users should be aware that Lumi Nova: Tales of Courage provides CBT (including psychoeducation and exposure therapy) based on exposure therapy techniques in a gaming environment. A known aspect of exposure therapy is an induction of anxiety which through the graded exposures subsides and results in confidence building. A known risk of exposure therapy is exacerbation of existing psychological symptoms. Parents, guardians, education and healthcare professionals should be vigilant for exacerbation of anxiety symptoms which don’t subside when supporting young people while using Lumi Nova, stop game play if the young person becomes excessively anxious and contact the young person’s mental health worker or GP if necessary.
Further information regarding anxiety and young people can be found on the NICE website: https://www.nice.org.uk/guidance/cg159/ifp/chapter/Information-for-parents-and-carers.Users must not attempt out of app challenges without support from their ‘trusted adult’ such as a parent, guardian, carer, education or healthcare professional.
Cautions
This app is not a substitute for professional advice. You should consult your doctor, or other relevant professional before making any decisions that could affect your health or the health of others.
Technical Information
Pre-Use Requirements and Dependencies
This app facilitates CBT (including psychoeducation and exposure therapy) recommended as a treatment intervention by NICE Anxiety disorders Quality standard and the Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the treatment of anxiety disorders.
Access to this app will be provided to a child and their guardian either by self sign up via an online registration page or by an authorised health, education or social care professional (each user will receive a unique game key).
Lumi Nova: Tales of Courage is a digital therapeutic that helps with the symptoms of worries or anxiety for children aged 7-12 years with mild to moderate needs, helping them learn skills to self-manage their worries/anxiety in an engaging intergalactic adventure game (app). It is built on the therapeutic framework of Exposure Therapy (considered to be the ‘active ingredient' of CBT). It engages users in therapeutic content and related steps in a fun game environment.
As a health intervention, guardians must provide support to their child (app user) as and when needed. The guardian will receive SMS notifications as their child uses the app. The app will send push notifications prompting users to check in with their guardian when they require assistance with challenges.
When connected to the internet, the app will send usage data to a secure online hub called ‘VitaMind Hub’ which is only accessed by authorised staff in the health, social care or educational organisation responsible for providing you with access to the Lumi Nova app.
Lumi Nova: Tales of Courage is a Class 1 software as a medical device as part of the VitaMind offer by BFB Labs.
Please read our privacy policy to find out more about how we protect your data and privacy. Read Privacy Policy
Please read the Terms and Conditions of the app by clicking or tapping on this link Read Terms & Conditions
Software Installation, Upgrade and Configuration
Internet is needed to download the app (but not to use it). This app works on mobile devices on both Android and iOS platforms.
The app must be downloaded on a mobile device that the child will have access to.
Guardians must download the app from the Apple store or the Google Play store.
Once downloaded, guardians will need to input their unique game key they would have received via SMS on their mobile phone as a result of the distributor providing access to the game - this will unlock the game. Before handing the device to the child, the guardian must shortlist 3 goals for the child to complete challenges for.
New version updates will get installed (automatically or manually depending on device settings chosen by the user).
Step by Step Instructions
Once the user (child) has access to the app, they can play for 30-40 minutes each day. The app self-concludes each session after 30-40 minutes depending on the challenge the child attempts or completes.
At the start, the game asks the guardian of the child (player) to shortlist 3 goals out of a menu of goals (feared scenarios) that are appropriate to their child.
Based on their answers, the game offers players with 3 goals to choose from. The player chooses a goal (feared scenarios they’d like to work on first).
The goals relate to the most common feared scenarios for this age range (7-12 years). These fall into three anxiety types:
Social Anxiety
Separation Anxiety
Phobias
Each goal is broken down into multiple challenge steps. The game shows the player all of the graded challenges within that goal from least scary to most scary. Some of the challenges are in-game simulations and some are out of game (in-vivo, planned and attempted with Guardian’s support - Guardian is apprised of child’s progress via automated SMS).
The player completes psycho education through immersive storytelling in the game, and starts to attempt their graded challenges. As the player attempts/completes each new challenge, they reflect on how they’re feeling, and earn exciting rewards. This contributes to understanding the process of breaking down fears into graded byte sized challenges, and attempting them to build confidence.
The game comprises the following:
Story based psycho education
Option of goals for most common childhood anxieties (social, separation, phobias)
Thought diary
Voice guided imaginal exposure challenges, interactive multimedia exposure modules, gyroscopic environments
Voice guided real world (in-vivo) challenges
Gamified reward system for attempting and completing challenges
Option to revisit psycho education any time during game play
Option to repeat challenges
Automated SMS alerts to guardian
30-40 minute play time limit per session per day
Automated push notification reminders
Compatible with iOS and Android mobile / tablet devices
Access to ongoing game enhancements and new content
USERS MUST NOT ATTEMPT OUT OF APP CHALLENGES WITHOUT SUPPORT FROM THEIR GUARDIAN.
Troubleshooting
What if I forget my user key to download the game or access out-of-game challenges?
If you forget your user key, contact BfB Labs at support@bfb-labs.com
Users can still play the game while they wait - they can log in again to repeat old challenges and keep earning rewards.
What if I the game stops working?
If you have any technical issues with the game, contact BfB Labs at support@bfb-labs.com
COMPLETING OUT OF GAME CHALLENGES
How much anxiety should I expect?
It’s normal for a user (child) to feel worried - it’s important for them to try each challenge anyway.
Users should do each challenge until their anxiety goes down by half. The game will ask them to rate their worry from 1-10, so ask them how they’re feeling before each challenge. If they start at 8/10 worried, they should keep at it until they only feel 4/10 worried.
What if a user is too worried to do a challenge?
It’s normal for users to feel worried - remind them you believe they can do it anyway!
If user experiences physical symptoms of anxiety (fast heartbeat, sweating, tummy ache), take a break and remind them to take deep breaths.
Praise users for being brave enough to try a challenge!
Encourage users to give it another go soon so they can learn how to cope with feeling worried.
If users need to keep practicing to build their confidence first, they can log in to the game and choose old challenges to repeat.
What if a user can’t do an out of game challenge?
When waiting to complete an out of game challenge, users can still play the game while they wait. They can log in again to repeat old challenges and keep earning rewards.
If a user can’t complete an out of game challenge, then they can log in to the game to replace that challenge with a different one to keep making progress toward their goal.
Remember not to skip challenges because of the user’s worry - they have to try out each challenge in order to learn that they can cope and be brave!
FINDING EXTRA SUPPORT
If you have questions about the app then you can find more info on www.luminova.app
If you are concerned about user’s anxiety or any other aspect of their mental health, discuss this with your GP.
Technical Specifications
The product Lumi Nova: Tales of Courage is a piece of software in the form of an application that works on both Android and iOS platforms. It does not include any hardware.
Regulatory Information
UK: Lumi Nova is software as a medical device Class 1 (as per the MHRA guidelines) and is compliant with the following regulations and standards:
Medical Devices Directive 93/42/EEC (MDD)
General Data Protection Regulation (EU) 2016/679 (GDPR)
Applicable national data protection and health legislation
ISO 13485:2016 for medical device quality management (part application)
ISO 14971:2019 for medical device risk management
ISO 15233-1:2016 for medical device symbols
IEC 62304:2006 + Amd 1:2015 for medical device software development lifecycle
Any configuration of the software is carried out pursuant to the NHS Health IT Safety Standard DCB0129.
AUSTRALIA: excluded Therapeutic Goods (Software-based Products) TGA
Previous labels
May 2023 - Jan 2024
May 2021 - May 2023
Sep 2020 - May 2021
Launch in May 2020 - Sep 2020
