Clinically validated digital therapeutic launches with UKCA mark and NHS support

A prescription-only digital therapeutic designed to treat depressive disorder has launched in Great Britain, marking a significant step in the integration of regulated mental health technologies into NHS care pathways.

Developed by Otsuka Pharmaceutical and Click Therapeutics, Rejoyn is a six-week treatment programme delivered via smartphone. Unlike general wellness apps, Rejoyn is classified as a medical device and requires a healthcare professional to prescribe it. The app combines cognitive emotional training exercises with brief therapeutic lessons to enhance cognitive control of emotion – a clinically recognised deficit in individuals living with major depressive disorder (MDD).

Rejoyn’s rollout follows the results of the MIRAI study, a pivotal 13-week, randomised controlled trial involving 386 patients diagnosed with MDD and already receiving antidepressant medication. Participants using Rejoyn showed a statistically significant improvement in depression symptom severity when compared with those using a sham control app, measured using the MADRS and PHQ-9 clinical scales. Importantly, no treatment-related adverse events were observed in the Rejoyn group.

The launch comes amid growing demand for scalable, accessible mental health interventions. Around one in six adults in Great Britain are estimated to experience moderate-to-severe depressive symptoms during their lifetime, with over two million currently on NHS waiting lists for mental health support.

“Rejoyn offers patients a structured, evidence-based tool they can use at home – while remaining connected to their care team,” said Dr Rob Baker, GP.

Rejoyn is now available through select NHS Trusts and has received a UK Conformity Assessment (UKCA) mark and certification under the NHS Digital Technology Assessment Criteria (DTAC). A wider rollout is expected in the coming year.