JUL 27, 2021 8:30 AM PDT

First Prescription Digital Therapeutic Expands Access to Mental Health Care

WRITTEN BY: Ryan Vingum

Treatment for disorders like depression and anxiety usually requires regular visits to a psychiatrist or, at the very least, regular sessions over video. However, according to the Chief Science Officer for Happify Health Dr. Acacia Parks, a significant percentage of people struggling with generalized anxiety disorder (GAD) and major depressive disorder (MDD) don’t get the treatment they need.

“There are research-validated approaches for addressing depression and anxiety, but getting those approaches to the general public is a massive challenge that Happify Health is serious about tackling.”

That’s why Happify Health has launched a new digital tool, Ensemble, which is the first prescription-based digital treatment tool for people 22 years of age or older with MDD or GAD. Ensemble delivers important treatment and interventions to psychiatric patients wherever they may be, offering a new therapeutic option.

Digital therapeutics have been on the rise recently, with the global digital therapeutics market forecasted to be worth nearly 4.9 billion by 2026. Additionally, digital therapeutics (such as digital apps) are being recognized as something that are here to stay and that could have potential benefits for patients with a range of medical conditions. What sets Ensemble apart from other digital therapeutics on the market is that a clinician must prescribe the tool to their patient.

The tool, based on a program of cognitive-based therapy and mindfulness education training exercises, is a 10-week program that is intended to help people identify, understand, and learn to change thinking and behavior caused by GAD or MDD. Specifically, the program uses clinically-validated measures, such as PHQ-9 and GAD-7, to help health care providers monitor patient progress and response to treatment. The tool also has an AI, named Anna, that was developed by a team of writers, researchers, and doctors. Anna provides a communicative outlet for patients, replicating real human connection to help coach patients through the activities provided by the app.

Ensemble is currently being launched under the FDA’s Enforcement Policy, which allows for the use of new tools to treat psychiatric conditions during the COVID-19 pandemic. However, it has not been FDA-approved as a treatment for MDD or GAD. Happify Health is conducting a study of this investigational device to learn more about its efficacy for treating psychiatric illnesses, and interested participants should talk to their doctor to find out if using Ensemble could work for them.

Sources: Businesswire; Journal of Family Medicine and Primary Care

About the Author
Master's (MA/MS/Other)
Science writer and editor, with a focus on simplifying complex information about health, medicine, technology, and clinical drug development for a general audience.
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