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Evaluation of digital therapeutic for depression

Overall summary

Depression is one of the most prevalent mental health disorders, affecting around one in six adults in the UK. Current treatments include a combination of self-help, talking therapies and medication, as well as digital therapeutics. These are software-based therapies that have undergone clinical trials and regulatory review. Cognitive behavioral therapy (CBT)-based digital therapeutics have been shown to be an effective treatment for depression.

Otsuka, a pharmaceutical company, is developing a new digital treatment for depression: ‘CARE for MDD’ is digital therapeutic app that delivers a standalone six-week programme based on a new cognitive task combined with CBT-based psychotherapy lessons. It has the UK Conformity Assessed (UKCA) mark.

Health Innovation Oxford and Thames Valley (Oxford HIN) conducted a feasibility study and engaged with key stakeholders in the NHS depression pathway to assess the clinical need, perceived potential benefits, acceptability and barriers to adoption of the app for people with moderate depression.

What is the challenge?

Almost two million people are referred by their GP to NHS Talking Therapies services every year. More than one million contacts are made with these services annually. Referral rates are rising – in 2021/22 there was an increase of 21.5% over the previous year. Not all people with depression respond to current treatments. New treatments could meet the needs of more patients.

What did we do?

We carried out a feasibility study to gain an understanding of the clinical need for CARE for Major Depressive Disorder (MDD) in the NHS depression pathway and to collect views of clinicians on the perceived usefulness of the platform, its level of acceptance and potential barriers to adoption. We engaged with 20 clinical stakeholders with relevant roles in the depression pathway across several NHS trusts. We conducted semi-structured interviews comprising both qualitative and quantitative questions designed to better understand the potential of CARE for MDD as a treatment for depression in NHS services. Data was thematically analysed and collated in a report.

What has been achieved?

The feasibility study showed that NHS clinicians perceived CARE for MDD to be an interesting additional treatment option that could widen the current treatment offer. Moreover, it could provide an alternative treatment modality to patients who do not respond well to current treatments for depression. Clinicians felt that access to the app could be useful in supporting people with depression in a number of NHS settings including primary care, Talking Therapies services and secondary care services for eligible patients, with some adjustments. However, to use CARE for MDD with confidence clinicians would need to see evidence of its clinical effectiveness, preferably obtained in an NHS setting to better understand how it could be integrated.

What people said

“This project was incredibly valuable to us as it provided insights that allowed us to plan our next steps effectively to ensure we can meet the expectations of the clinical stakeholders in the NHS. I very much appreciated the expertise that the Oxford HIN team provided and look forward to continuing to work with the team on future activities.”

Elcie Chan, EU Commercial Director – Digital Health, Otsuka

What next?

An operational pilot is needed to determine potential placement and integration of the CARE for MDD digital therapeutic within the NHS depression pathway. Approval from the National Institute for Health and Care Excellence (NICE) is also required before it can be integrated into the NHS care pathway.

The product is currently UKCA marked but is undergoing further development and improvement to be ready for commercial release. An observation pilot and health economics will continue in 2024/25.


Florence Serres, Project Manager