Happify launches Ensemble DTx for depression, anxiety in US

Happify Health has launched a prescription digital therapeutic (DTx) – called Ensemble – that can assist the treatment of people with both major depressive disorder and generalised anxiety disorder in the US market.

The 10-week smartphone or PC based programme is the first and only prescription DTx for both indications, which according to the digital health company often together in around 20% of patients with MDD in a 12-month period.

It has been launched for people aged 22 and over under a pandemic-related waiver in the US legislation that has allowed digital tools for mental health conditions to reach the market without having to go through the FDA’s usual premarket notification requirements.

Alongside the launch, Happify is recruiting users into a research study that will provide data "for regulatory and commercial purposes."

People with MDD are almost six times more likely to have GAD than those without depression, according to Chris Wasden, Happify's head of DTx, who says that Ensemble is designed as an adjunct to clinical care for the conditions and must be prescribed by a healthcare professional.

Ensemble aims to teach patients new skills and habits to take control of their anxiety and depression, via cognitive behavioural therapy (CBT), mindfulness, and behavioural science-based techniques and activities.

It features an artificial intelligence-based digital coach, called Anna, that has been trained specialists to provide human-like interactions and is designed to increase engagement with the programme by patients.

"Ensemble has been designed as a single treatment that targets underlying processes that are common to both MDD and GAD," said Happify's chief medical officer Murray Zucker.

"Decades of research have established that psychological interventions, including those included within Ensemble, are helpful for both disorders."

Happify already sells an eponymous consumer-focused wellness app designed to help people reduce stress, overcome negative thoughts, and build greater resilience, and last year launched Kopa for Psoriasis, one of a series of planned management platforms intended to provide support and a community for people with chronic conditions.

The company has meanwhile also been partnering with other organisations to develop other versions of its digital health platform, and started working with dermatology specialist Almirall earlier this year on a tool called Claro to support mental health in people with psoriasis.

In 2020, it also teamed up with the American Heart Association (AHA) to develop an app that aims to reduce stress and encourage healthy behaviour in people with high blood pressure and high cholesterol.