Major depressive disorder (MDD) and generalized anxiety disorder (GAD) often go hand in hand. About 20% of individuals diagnosed with MDD experience symptoms of GAD within 12 months of diagnosis, and most people diagnosed with one condition will experience the other at some time during their lives. Happify, a multimodal digital therapeutic for mental health, has launched a new solution to its comprehensive platform that addresses both MDD and GAD. Known as Ensemble, the prescription service complements clinical care for both conditions.

Patients with MDD or GAD can access Ensemble on a computer or smartphone. It educates and supports users in building new skills and habits that help them manage depression and anxiety symptoms. Based on cognitive-behavioral therapy (CBT), Ensemble’s trainings progress sequentially, using research-based techniques that enhance user interest and engagement.

Through CBT, Ensemble helps users identify and reduce negative thoughts and enhance their focus on positive goals and changes. A physician dashboard lets providers monitor patients during the 10-week program and view progress measured by Ensemble’s integrated, clinically validated assessment tools. The research behind CBT, as well as studies of Happify’s other programs, suggest that Ensemble could help patients implement life-long habits that can significantly impact MDD and GAD.

Ensemble itself, however, hasn’t yet been studied in clinical trials. Its release as an investigational device falls under an FDA advisory created in response to the COVID-19 pandemic. That advisory states that the FDA “does not intend to object to the distribution and use of computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders” to facilitate greater access to mental health services during the pandemic. 

Ensemble’s initial enrollees have the option to participate in an FDA investigational research study. Individuals interested in Ensemble can visit to learn more about the product and study eligibility.