Happify Launches the First Prescription Digital Therapeutics to Treat Both MDD and GAD

Ensemble is the first transdiagnostic PDT for MDD and GAD available in the U.S.

Happify Health, a global software-enabled healthcare platform, today announced the launch of Ensemble, the first and only transdiagnostic prescription digital therapeutic for the treatment of patients who have Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD).

Designed as an adjunct to care for MDD and GAD, Ensemble must be prescribed by a clinician to treat these disorders. It is accessible via smartphone or computer, and teaches patients new skills and habits to take control of their 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,” said Dr. Acacia Parks, Chief Science Officer of Happify Health. “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.”

“Data shows that people with MDD are 5.7 times more likely to have GAD than people without MDD. Additionally, 20% of people with major depressive disorder also meet criteria for GAD in a given 12-month period,” said Chris Wasden, Head of DTx at Happify Health. “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.”

Most people who are diagnosed with depression will also meet criteria for an anxiety disorder at some point in their lives and vice versa," said Dr. Murray Zucker, Chief Medical Officer at Happify Health. "Ensemble has been designed as a single treatment that targets underlying processes that are common to both MDD and GAD. Decades of research have established that psychological interventions, including those included within Ensemble, are helpful for both disorders. Additionally, our digital AI coach, Anna, has been trained by a team of clinicians, psychotherapists, content creators, writers, data scientists, and research psychologists to provide human alliance and connection, as well as a tailored experience designed to increase engagement for patients."

Developed by a team of experts, research scientists, and doctors who are passionate about improving people's lives, Ensemble delivers skills training based on cognitive behavioral therapy (CBT), mindfulness, and related forms of behavioral science-based techniques and activities designed to treat the symptoms of MDD and GAD. The 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.

Ensemble can help patients change their negative thinking patterns, learn to focus attention on things that can help advance their goals and feel good, and track their progress over time. Using CBT, Ensemble focuses on teaching patients how to identify and change unhelpful patterns of thinking and behaving. Ensemble provides patients with the skills to implement real, long-lasting change in their state of mind, ultimately unlocking the freedom and control to live more fully. By following Ensemble’s 10-week program, patients can expect to:

• Reduce depression and anxiety symptoms
• Learn life-changing skills that are based in science
• Develop lifelong healthy habits

At launch, patients diagnosed with MDD or GAD will be eligible to participate in a research study of Ensemble as an investigational device released under FDA’s Enforcement policy. Interested patients can learn more about participating in these studies and getting access to Ensemble by visiting www.getensemble.com. Happify Health will use the data collected from these studies for regulatory and commercial purposes.

Ensemble Indications for Use:

• Ensemble is a prescription-only digital therapeutic intended to provide neurobehavioral interventions based upon cognitive behavioral therapy (CBT), mindfulness, and positive psychology for Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) in patients 22 years or older. Ensemble treats patients with MDD and GAD by improving a patient’s symptoms.

Ensemble Safety Information:

• Ensemble should be used under supervision of a Health Care Provider (HCP). Only an HCP with prescription privileges can prescribe Ensemble.
• Recommendations provided by the device are adjunctive (supporting) and should not be solely or primarily relied upon to treat MDD or GAD. Ensemble is not intended to be used as a standalone therapy for MDD or GAD. Ensemble does not represent a substitution for a patient’s medication.
• Ensemble has not been clinically tested and may therefore have unknown benefits and risks. Ensemble has not been cleared by the FDA.
• Patients should not use Ensemble to communicate to their clinician any urgent or emergency situations. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

About Happify Health:

Happify Health is a global software-enabled healthcare platform. We design and deploy software to help improve mental health, physical health and well-being. We are creating a future where better health outcomes can be powered by technology—leading to more personalized care that can improve the everyday lives of more people.

The Happify Health platform offers a full spectrum of science-backed Digital Therapy and Care Journey solutions for customers and individual end-users; including Wellness, AI-based Coaching, Community, as well as Combination and Prescription Digital Therapeutics.

Our patient solutions are disseminated through unified products and services we deploy for the healthcare ecosystem; including enterprises, health plans, health systems, pharma and medical device manufacturers. Our global platform is available in 10 languages, supports more than 10 chronic conditions, and covers more than 20 million lives. For more information, visit www.happifyhealth.com.

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