Happify unveils the first digital therapeutics to treat both MDD and GAD

Designed as an adjunct to care for MDD and GAD, Ensemble must be prescribed by a clinician to treat these disorders.

Ensemble by Happify Health

Happify Health 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.

How does it work?

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.

On the record

“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.”

The context

According to the “Digital Therapeutics – Global Market Trajectory & Analytics” report, the global digital therapeutics market is expected to reach $1.6 billion by 2027, growing at a CAGR of 24.6% over the period 2020-2027.

The Digital Therapeutics market in the U.S. is estimated at $103.8 million in 2020. The country currently accounts for a 29.9% share in the global market. China, the world’s second-largest economy, is forecast to reach an estimated market size of $282.8 million in 2027 trailing a CAGR of 24.1% through 2027.