Safety Information

Learning Effective New Strategies (LENS) is a digital mental health intervention developed by King’s College London, of which the overall purpose is to shift the way people think about ambiguous situations to be more positive and helpful. LENS achieves this through a drill-like training where users are prompted to visualise positive conclusions to numerous situations which are ambiguous and could be interpreted in either negative or positive ways. This training involves completing 12 sessions over 4 weeks. This type of training is known as cognitive bias modification for interpretation bias (CBM-I), which trains individuals to think in a more positive, adaptive way. The intended use of LENS is to reduce anxiety, depression and/or repetitive negative thinking in individuals with anxiety (low to high levels), depression (low to moderate levels), and/or repetitive negative thinking (moderate to high levels).

Regulatory Classification

The device fulfils the provisions of the UK Medical Devices Regulations (2002) as a class 1 software as medical device product. LENS has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) - please refer to the approval here: https://drive.google.com/file/d/1jN78iZm81czOesn6V8W6CQR-4T4LGioU/view?usp=sharing

Applicable Standards

This software product has been designed according to:

BS EN ISO 13485:2016+A11:2021 – Medical devices – Quality management systems – Requirements for regulatory purposes.

BS EN ISO 14971:2019+A11:2021 – Medical devices – Application of risk management to medical devices.

DCB0129:2018 – Clinical Risk Management: its Application in the Manufacture of Health IT Systems.

IEC 62304:2006 Amd 1:2015 – Medical device software – Software lifecycle processes.

This device has been developed under the strict quality system of King’s College London.

Please refer to the instructions for use before using LENS: 

Web-browser version:

https://drive.google.com/file/d/1ZesAot8YE4vbceCMFHACLFaADmEQ5xyZ/view?usp=sharing

App version:

https://drive.google.com/file/d/1J4kIZPQz6nnevMJ4PfEXCwjbeNh0CpaY/view?usp=sharing

LENS is being used within the Treatment Outcomes Prediction Study run by King's College London. Please refer to the Participant Information Sheet and Consent Form below:

• Participant Information Sheet:https://drive.google.com/file/d/13ndLIm2ojJ8BdQkbB_ek6UiOyYbMZ_s4/view?usp=sharing

• Consent Form: https://drive.google.com/file/d/1xKS2MrOLDVf_BFrQfNo1yW5t3QQkpXe9/view?usp=sharing

The Treatment Outcomes Prediction Study has received ethics approval from the King's College London Research Ethics Committee. Please refer to the ethics approval here: https://drive.google.com/file/d/1JNGKLIqfr5LS3sVGchFJnmfKshDXcqBc/view?usp=sharing

You can report any safety concerns involving LENS to the Yellow Card scheme. We advise that you complete the report as soon as possible and keep hold of the device, as a further review might be needed from us or the Medicines & Healthcare products Regulatory Agency. Everyone is different and therefore it is very difficult to predict whether an individual will experience a side effect. You can help others by reporting side effects to the MHRA Yellow Card scheme. 

For more information, please refer to https://yellowcard.mhra.gov.uk/medical-devices 

To report a side effect, please visit https://yellowcard.mhra.gov.uk/