Happify is taking advantage of relaxed FDA rules to release a prescription-only app for treating people with both major depressive disorder and generalized anxiety disorder.
The app, called Ensemble, offers a 10-week program to people aged 22 and older. The company has been able to launch the app thanks to a pandemic-related waiver that allowed digital tools for mental health conditions to enter the market without going through the usual FDA requirements.
Digital therapeutics — Happify says it is recruiting users into a research study to provide data on Ensemble’s effectiveness, so that it can receive full FDA approval.
The company claims Ensemble teaches patients new skills and habits to take control of their anxiety, and is to be prescribed by a doctor and used in conjunction with clinician care, but not by itself. It’s basically a tool that patients can use throughout their day to practice mindfulness and learn to focus on healthy thinking; the app uses a digital coach called Anna to provide reminders and increase engagement in the lessons. It says Anna is able to ask patients questions and intelligently respond with useful insights.
The pandemic put a spotlight on virtual care, as stress increased and options for in-person care were limited. Plus, the American healthcare system doesn’t put a lot of value on mental health, and it’s often prohibitively expensive, even for those with health insurance.
There have long been questions about the effectiveness of digital therapeutics, like virtual therapy apps. But recent studies have suggested that digital solutions can be nearly as effective as in-person treatment, at least for some patients. A 2016 metanalysis, for instance, looked at 452 studies of telepsychiatry and found high patient satisfaction and quality equivalent to in-person care.
Gift for the GAD — Generalized anxiety disorder (GAD), in particular, is one that requires changing ones thinking patterns to focus less on negatives. According to research cited by Happify, more than 90 percent of things people with GAD worry about never come true. Its app is supposed to provide regular lessons that decrease depressive symptoms.
There are still legitimate concerns when it comes to digital therapy, though. Talkspace, a provider of text-based therapy, received criticism last year following claims that it didn’t respect user privacy and exaggerated the effectiveness of its treatments. But therapy-by-text varies from other digital solutions.
YMMV — It’s probably a good thing that Ensemble is available by prescription, as a medical professional can act as an accountability buddy, making sure patients complete the daily 15- to 30-minute activities.