Happify Health has launched a digital therapeutic designed to help diagnose and manage major depressive disorder as well as generalized anxiety disorder, as the two conditions often go hand-in-hand.
Offered as a supplement to standard care, the prescription Ensemble app includes courses for daily skills and coping habits as well as a digital coach named Anna that provides content from psychologists and psychotherapists aimed at the mental processes common to both anxiety and depression.
“The worldwide epidemic of depression and anxiety rages on, affecting 1 in 5 people—but between 30-40% of those needing treatment for these disorders do not receive it for one reason or another,” Happify’s chief science officer, Acacia Parks, said in a statement.
Ensemble was also born out of another epidemic—the worldwide spread of COVID-19. During the early stages of the pandemic in April 2020, the FDA announced a policy to expand the use of low-risk digital tools for psychiatric disorders, to help reduce patient-and-provider contact amid lockdowns and social distancing measures.
Happify’s investigational app, which relies on a 10-week cognitive behavioral therapy program, is currently being offered under this agency policy, and users may be able to enroll in the company’s virtual research study to help test its safety and efficacy. The app has not been cleared by the FDA.
“With mental health disorders exploding as a result of the pandemic, significant shortages of mental health clinicians, high costs of treating mental health disorders and a high degree of variability in applying cognitive behavioral therapy, mindfulness and positive psychology to treat these patients, clinicians need an evidence-based therapy like Ensemble to treat their patients,” said Happify digital therapeutics head Chris Wasden.
At the same time, people with a major depressive disorder are over five times more likely to have generalized anxiety disorder, compared to those without, Wasden said, and that about 20% of people diagnosed with depression also meet the criteria for anxiety over the course of a year.
The app includes a dashboard for physicians to help monitor their patients’ progress while tracking improvements using clinically validated questionnaires. Happify has previously used its digital platform in collaboration with pharma companies to help treat mental health issues that may come along with chronic medical conditions—such as with the Spanish drugmaker Almirall in patients with severe psoriasis and with Sanofi in multiple sclerosis.
This past March, Happify raised $73 million to help expand its digital reach and pharma partnerships. The company’s series D round was backed by Deerfield Management, Omega Capital Partners, ION Crossover Partners and other previous investors.