By Omar Ford

Happify Health is targeting major depressive disorders (MDD) and generalized anxiety disorders (GAD) with its latest prescription digital therapeutic (PDT) offering.

The New York-based company said Ensemble is designed as an adjunct for care to MDD and GAD. The PDT is accessible through smartphones or computers and teaches patients new skills and habits to take control of their anxiety and depression.

“The product is composed of 112 neurotherapeutic interventions,” Head of Happyify, Chris Wasden told MD+DI. “What that means is they are cognitive behavior therapy, mindfulness, and positive psychology-based, and the patients will complete two of these per day. Each one takes roughly 10 to 15 minutes to complete, so the patients will be conducting about 15 to 30 minutes of activities per day that are similar to the ones they would get if they went to a psychologist’s office.”

Ensemble’s techniques and activities are sequenced to achieve the desired outcome, with the ability to measure patient mental health improvement and outcomes using clinically validated instruments (PHQ-9 and GAD-7). Ensemble includes a physician dashboard for patient monitoring and uses the science of engagement to increase patient adherence.

He added, “part of the issue with going to psychotherapy is it’s a large commitment. You have to take time off from work. It’s easily a two-to-three-hour commitment – and that’s just to do one session. Whereas at the end of 3 hours and 30 minutes for our intervention you can do about six of those types of interventions. What you find in the normal world – because of the significantly greater burden on the patient to get these interventions done, you have a very low completion rate.”

The Ensemble PDT has its roots in a policy FDA announced in April 2020 that would expand the availability of digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19 during the pandemic.

“We decided to use that market authorization to bring a product to market that has not yet been cleared by FDA,” Wasden said. “We would then gather data from the use of our product for hundreds of patients so we could use that in an FDA filing.”