Oshn Instructions for Use
Introduction
Please read this instruction manual thoroughly before using the Oshn app.
Product Outline
Product Details
Oshn is an evidence-based, gamified digital intervention designed to support young people aged 11-25 years to self-manage low mood and boost motivation by building confidence, resilience, and personal wellbeing through meaningful real-world actions and connection.
For 11-12 year olds: consent must be provided by a parent/carer/guardian.
For 13- 15 year olds: supervision should be provided by a parent/carer/guardian.
Oshn is a Class 1 software as a medical device (SaMD) as part of the VitaMind offer by BFB Labs. Oshn does not provide diagnosis, prediction, or clinician decision support.
Product Description
Oshn is based on a type of Cognitive Behavioural Therapy (CBT) called Behavioural Activation (BA). BA is based on a simple idea: that what you do shapes how you feel.
Oshn helps users understand the link between thoughts, feelings and behaviours (psychoeducation), discover their values, and suggest quick ‘in-the-moment’ activities aligned with those values. Even a few minutes spent on a meaningful activity can make a difference, helping users feel more engaged and being able to self-manage difficulties they may be facing with low mood and reduced motivation.
It does not provide diagnosis, prediction, or clinician decision support.
In particular, Behavioural Activation, is recommended by NICE for those over 18 and as an alternative for children struggling with CBT concepts or those with learning disabilities or neurodevelopmental conditions (sources here and here).
The software tracks progress of the user through questionnaires and analytics and this information is made available to the organisation(s) purchasing the service via the VitaMind Hub, however it is not intended to be used to make clinical decisions.
The software is accessible via the Google Play store and the Apple App Store.
Instructions for Use
Please read this instruction manual thoroughly before using the Oshn app. Please keep these instructions for future reference.
Intended Use
The Oshn app can be used by young people aged 11-25 years to self manage low mood and boost motivation, with or without a clinical diagnosis, determined by the user, a parent/carer/guardian, or an authorised professional from health, education, youth services.
For 11-12 year olds: consent must be provided by a parent/carer/guardian.
For 13- 15 year olds: supervision should be provided by a parent/carer/guardian.
Oshn is only accessible in areas and services where it has been commissioned. To gain access, users will either live in a commissioned service area or have an access code to use the app once downloaded.
User Experience
Oshn has a friendly and neutral theme of an ocean. The visual style is specifically rendered to ensure a high level of inclusivity, consisting of an ocean background and ocean-based creatures (assets) that serve as rewards from time to time.
It does not allow any exchange with other users or 3rd parties and does not contain any in-app purchases.
In the app, the first session and onboarding process is designed to set up the user's profile and introduce the therapeutic foundation of Oshn.
The user registers by providing demographic data, including a first/nickname, date of birth, postcode, e-mail, gender, ethnicity, disability, care experience, education and where appropriate, NEET status. The user is then presented with psychoeducational content to help understand the link between their thoughts, feelings, and behaviors, along with the core concept of the Behavioural Activation therapeutic model.
During the initial app set up, the user must shortlist 5 values as part of the onboarding. These can be changed at a later stage. During the first session, the user will complete psychoeducation before they are able to attempt their first activity.
A list of short, value-aligned activities from a pre-set database will be presented to the user. As the user attempts/completes a set number of activities, they earn rewards.
The app comprises of the following features:
Psychoeducation onboarding
Value selection, resulting in suggested activities are meaningful and aligned with BA principles from a database of 6k+ value-based activities
Gamified dynamic reward system for completed activities
Log of completed activities
Optional push notification reminders
Weekly check-in survey based on validated questionnaire, displayed on 4 sliders repeated weekly
Compatible with iOS and Android mobile / tablet devices
Access to ongoing game enhancements and new content via scheduled respective app store updates.
Indications for Use
The Oshn app can be used by young people aged 11-25 years to self manage low mood and boost motivation, with or without a clinical diagnosis, determined by the user, a parent/carer/guardian, or an authorised professional from health, education, youth services.
For 11-12 year olds: consent must be provided by a parent/carer/guardian.
For 13- 15 year olds: supervision should be provided by a parent/carer/guardian.
There are no known misuses of the offering.
Contraindications
Oshn is not intended to be used by:
Young people aged 11 - 12 years who do not have consent from their parent/carer/guardian to use Oshn.
Young people aged 13 - 15 years who do not have parental/carer/guardian supervision.
Young people 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.
Safety Information
Safety Instructions
Oshn is not suitable for individuals with moderate-to-severe mental health conditions (unless supervised by a mental health professional.), active self-harm, or suicidal ideation.
In-app ‘help’ information signposts users to other available support as shown below:
Need help right away?
Get help from 111 online or call 111 and select the mental health option.
If you can - tell a trusted adult (parent, teacher, counsellor) what’s happening.
You should call 999 or go to your nearest A&E if:
Someone's life is at risk – for example, someone is seriously injured or has taken an overdose.
You do not feel you can keep yourself or someone else safe.
A mental health emergency should be taken as seriously as a physical one. You will not be wasting anyone's time.
Need to talk to someone?
Call 116 123 to talk to Samaritans any time day or night, or email: jo@samaritans.org - it may take several days to get a reply by email.
Text "SHOUT" to 85258 to contact the Shout Crisis Text Line, or text "YM" if you're under 19.
If you're under 19, you can also call 0800 1111 to talk to Childline. The number will not appear on your phone bill.
These services will only share your information if they are very worried about you or think you are in immediate danger.
For more information and advice please visit the NHS website: Where to get urgent help for mental health
Optional sign posting to a local support website may also be provided by the commissioning Organisation.
No other contraindications identified.
Neurodivergence and SEND
When using Oshn to support neurodivergent young people or those with special educational needs and disabilities (SEND), it is advised to do so under the guidance of their parent/carer/guardian or authorised health/care/education professional. Ensure necessary adjustments are made beforehand to accommodate their needs.
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.
General Precautions
(Include general precautionary information here from the Clinical or Performance Evaluation Report, Risk Management Report or User Validation Report.)
No adverse events related to Oshn have been reported to date.
Oshn is not intended to support:
Young people aged 11 - 12 years who do not have consent from their parent/carer/guardian to use Oshn.
Young people aged 13 - 16 years who do not have parental/carer/guardian supervision.
Young people 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.
Pre-Use Requirements and Dependencies
For 11-12 year olds: consent must be provided by a parent/carer/guardian.
For 13- 16 year olds: supervision should be provided by a parent/carer/guardian.
Oshn will send optional push notifications prompting users to revisit the app to complete activities 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, education, youth services responsible for providing you with access to Oshn.
Oshn is a Class 1 software as a medical device as part of the VitaMind offer by BFB Labs.
Please see the Privacy Notice which sets out how the organisation who provided access to Oshn for you makes use of your personal information (they may well have provided their own Notice too) and how we, BfB, make use of it.
Read Oshn Privacy Notice
Please also read what we allow you to do/ what you must not do as a User of the App.
Read Oshn Terms of Use
Software Installation, Upgrade and Configuration
Oshn is only accessible in areas and services where it has been commissioned. To gain access, users will either live in a commissioned service area or have an access code to use the app once downloaded.
Internet connectivity is required to download the app, user selected content, and send data to the VitaMind Hub.
Oshn runs on iOS and Android mobile devices. Download the app from the Apple App Store or Google Play Store onto a device accessible to the young person.
App updates will install automatically or manually, depending on the user's device settings.
Step by Step Instructions
Oshn is only accessible in areas and services where it has been commissioned. To gain access, users will either live in a commissioned service area or have an access code to use the app once downloaded
Users gain access through two routes:
Postcode: Entering a postcode verifies eligibility in a commissioned area before account creation.
Referral: Receiving an email invitation with an access code unlocks the app.
Once a user has accessed the app:
The user registers and creates a personal profile by providing basic details (first/nickname, DOB, postcode, email, gender, ethnicity, disability, care experience and education and where appropriate NEET status and how they heard about Oshn. ).
If the user is 13-15, a parent/carer/guardian should provide supervision.
If the user is 11-12, the parent/carer/guardian will complete steps 1 (or 2, depending on access format) and 3, before handing the device to the young person.
The user goes through the initial psychoeducation content to understand the link between thoughts, feelings, and behaviors, which is the foundation of Behavioural Activation (BA).
The user selects 5 personal values important to them from the app's library, which helps tailor subsequent activity suggestions.
The user reviews and selects quick, 'in-the-moment' activities, which are aligned with their chosen values and life areas.
The user engages with and completes their selected in the moment activities.
The user completes a weekly self-rating (Outcome Rating Scale or Child Outcomes Rating Scale for young people 11-12) on sliders for individual, interpersonal, social, and overall wellbeing/functioning.
The app aggregates these inputs to display a graph and a visual progress tracker, showing the user trends in their self-reported functioning and tracking completed activities.
Troubleshooting
What if I accidentally delete my access code to download the app. If you misplace your access code, contact support@bfb-labs.com.
What if the app stops working? If you have any technical issues with the app, contact support@bfb-labs.com
FINDING EXTRA SUPPORT
If you have questions about the app then you can find more info on oshn.app. If you or your young person needs support then see below:
Need help right away?
Get help from 111 online or call 111 and select the mental health option.
If you can - tell a trusted adult (parent, teacher, counsellor) what’s happening.
You should call 999 or go to your nearest A&E if:
Someone's life is at risk – for example, someone is seriously injured or has taken an overdose.
You do not feel you can keep yourself or someone else safe.
A mental health emergency should be taken as seriously as a physical one. You will not be wasting anyone's time.
Need to talk to someone?
Call 116 123 to talk to Samaritans any time day or night, or email: jo@samaritans.org - it may take several days to get a reply by email.
Text "SHOUT" to 85258 to contact the Shout Crisis Text Line, or text "YM" if you're under 19.
If you're under 19, you can also call 0800 1111 to talk to Childline. The number will not appear on your phone bill.
These services will only share your information if they are very worried about you or think you are in immediate danger.
For more information and advice please visit the NHS website: Where to get urgent help for mental health
Technical Specifications
Oshn 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
Oshn 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.