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

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 BFB Labs. 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

During the initial app set up, the parent/carer must shortlist 3 missions from a menu of 15 feared scenarios that their child will later be able to select from.

The missions 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 mission contains 7-10 exposure challenges based on the mission chosen, and is broken down into 3 goals - short, medium and long term.

The short term goal is expected to be completed over a 2-4 weeks period and requires the young person to complete 3-5 in game exposures such as imagine, drawing, looking at photos and watching videos or 360 videos in the app followed by their 1st real life challenge which must be supported by a parent/carer who is responsible for unlocking and approving that the challenge has been completed using their game key.
The medium term goal is expected to be completed over a 6-8 weeks period and requires the young person to complete 1-2 real life challenges supported by their parent/carer. (parent/guardian supervision is essential).
The long term goal is expected to be completed over a 3-6 months period and requires the young person to complete their final 1-2 real life challenges (parent/guardian supervision is essential).

Before starting each goal, the game shows the player all of the graded challenges they must complete to achieve their next goal within their chosen mission. The challenges are easier to begin with and get gradually more difficult as they progress.. The first few challenges in their first goal, are in-game simulations and help the young person prepare for the more difficult real life challenges (in-vivo, planned and attempted with Guardian’s support - Guardian is apprised of child’s progress via automated SMS).

During the first session, the player completes psychoeducation through immersive storytelling in the game before they are able to attempt their first graded exposure challenge. This contributes to understanding the process of breaking down fears into graded byte sized challenges, and attempting them to build confidence.

As the player attempts/completes each new challenge, they reflect on how they’re feeling, and earn customisation rewards in the form of clothing and accessories in their wardrobe. e.

The game comprises the following:

Story based psychoeducation
Option of missions for most common childhood anxieties (social, separation, phobias)
Thought diary check in before and after each challenge
Voice guided imaginal exposure challenges, interactive multimedia exposure modules, gyroscopic environments
Voice guided real world (in-vivo) challenges
Gamified reward system for completing challenges
Option to revisit psycho education any time during game play
Option to repeat challenges to earn additional rewards
Automated SMS alerts to guardian
Max 30- minute reward gameplay 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 via scheduled App Store updates.

Indications for Use

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 with severe anxiety, in crisis, experiencing suicidal thoughts, or at risk of self-harm without the support of a mental health professional
Young people with severe mental health symptoms or diagnosis, who are not supported by a mental health professional.

Neurodivergence and SEND

When using Lumi Nova to support neurodivergent children or those with special educational needs and disabilities (SEND) who have worries, it is advised to do so under the guidance of their guardian or mental health professional. Ensure necessary adjustments are made beforehand to accommodate their sensory needs.

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 is not intended to be used by:

Young people who do not have parental or carer supervision
Young people with severe anxiety, in crisis, experiencing suicidal thoughts, or at risk of self-harm without the support of a mental health professional
Young people with severe mental health symptoms or diagnosis, who are not supported by a mental health professional.

Neurodivergence and SEND

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

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 to inform them if the next challenge will require their support. The app will send push notifications prompting players to revisit the app to complete challenges and continue their progress.

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

The Internet is needed to download the app and when the young person is ready to select their first mission. Once a mission has been selected, the challenges are downloaded onto the device’s local storage and the internet is no longer required to use the app. (We recommend the device is connected to the internet from time to time to ensure progress is saved and the app is kept up to date). 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, Google Play store or Amazon app 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 or registering via the self sign up form - this will unlock the game. Before handing the device to the child, the guardian must shortlist 3 missions for the child to select one from..

New version updates will get installed (automatically or manually depending on device settings chosen by the user).

Step by Step Instructions

The parent/guardian must activate their game key and complete the parent onboarding and shortlist 3 missions out of a menu of 15 missions (feared scenarios) that are appropriate to their child, before handing the device over to their child.
The young person can then customise their Luminaut character and complete a short tutorial to learn how to use the navigation controls, interact with characters in the game and complete puzzles.
The young person then receives psychoeducation through immersive story telling to understand the process of breaking down fears into graded challenges, and attempting them to build confidence.
The young person is presented with the option to choose the mission they would like to work on from the 3 missions previously shortlisted during the parent set up. Their selected mission is broken down into 3 smaller goals for the young person to achieve.
The first goal and all the challenges they need to complete to achieve it, is presented to the young person before they confirm their selection.
The young person can now attempt their first in-game challenge but must first complete a thought check by rating how worried they feel before the challenge from a scale of 1 (not very worried) to 5 (very worried).
A brief challenge description is shown to the young person before they start. Once the exposure challenge has been completed, a thought check is presented again to ask the young person how they felt during the challenge and if they had to do it again.
The young person receives a reward of clothing/accessories for the wardrobe and up to 30 minutes of reward gameplay is unlocked for the young person to explore.
Reward gameplay is optional and does not need to be completed for the young person to progress to the next challenge in their goal.
Return to the all on the following day to attempt another exposure challenge.

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 game key when asked to unlock or approve a real life challenge, tap on the “forgot your game key” link to receive a text message reminder. Alternatively, please contact BfB Labs at support@bfb-labs.com and confirm the mobile number you used to register.

What if 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 1-5, so ask them how they’re feeling before each challenge. If they start at 4/5 worried, they should keep at it until they only feel 2/5 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 users experience 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?

If a young person cannot do an out of game activity because of logistics or because it needs planning or scheduling, users can still repeat previous in game challenges to help build confidence and earn rewards.

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 the 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 a mobile 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