Treatment for anxiety or depression is now digital

A digital approach to treating Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD)

Under the FDA’s policy to treat psychiatric disorders during this public health emergency, Happify Health created a new investigational product called Ensemble.

Read FDA Guidance

What Are Digital Therapeutics?

Ensemble is a new investigational medical device that is intuitive, convenient, and backed by science to work in harmony with your life.

Because of COVID, the world is confronting a mental health crisis of unimaginable proportions.

There’s a growing gap between the number of people who need care, and the amount of providers available to deliver it. Ensemble helps provide you with the support to give your patients the best care possible.

Patients diagnosed with MDD or GAD may be eligible to participate in virtual a research study of Ensemble. This research study is designed to test the safety and efficacy of this investigational medical device. Participants will be compensated for their time.

During the study participants will complete two short, engaging activities right from a phone or computer for a total of 15-30 minutes per day. Through participation, they’ll learn skills that may help them gain better control over their anxiety or depression.

Ensemble will be provided at no cost to participants and they can withdraw from the study at any time without penalty.

A New Way Forward

Ensemble is a new investigational software-based Prescription Digital Therapeutic (PDT). It’s accessible via phone or computer and may help create meaningful behavior change for people who use it.

Why Ensemble?

Ensemble can give people the tools to help reduce stress and live more fully.

Convenient

No appointment necessary, available anytime, anywhere, and involves only two short activities for a total of 15-30 minutes per day.

Manageable

Treatment can be completed in 10 weeks.

Enjoyable

Ensemble’s user-friendly interface delivers short, engaging daily activities that are intuitive and pleasing to use.

Safe and Effective

Ensemble may teach participants skills to help gain control over MDD or GAD and potentially feel better.

Clinically-Developed

Researchers, scientists, and doctors developed Ensemble using skills based on CBT, mindfulness, and related forms of behavioral therapy—including positive psychology.

Advancing Science

People diagnosed with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) may be eligible to participate in a research study. Participants will be compensated for their time.

How It Works

Ensemble can give people the tools to help reduce stress and live more fully.

Ensemble delivers skills training based on CBT, mindfulness, and positive psychology.

Activities are thoughtfully sequenced to achieve the desired outcome.

Measures patient mental health improvement and outcomes using clinically validated instruments (PHQ-9 and GAD-7).

Facilitates connection to immediate resources if participant reports thinking about self harm; you'll be notified as well.

Includes a physician dashboard for participant monitoring.

Uses the science of engagement to increase participant adherence.

An AI-Powered Digital Mental Health Coach

Anna helps guide participants on a path to feeling like themselves again. Developed by clinicians and data scientists, interactions with Anna feel authentic and human—like talking with a trusted guide or coach. Over time Anna will develop a rapport with the participant that is formed through care, curiosity, active listening and familiarity.

This AI experience is built on our patented dialogue flow that increases Anna’s proficiency, along with a number of patent-pending mechanisms designed to create an alliance between participants and Anna.

Anna has been found to be effective in helping people stay engaged in their therapy.

The Science

Happify Health’s digital therapeutic products have helped more than 5 million users of all ages improve their mental health. Ensemble is our latest digital therapy and was born out of a desire to make treatment even more accessible to all and help improve people’s quality of life in a tangible way.

Ensemble was created with experts, research scientists, and doctors who are passionate about improving lives. This is the first and only transdiagnostic digital treatment for MDD or GAD and based on similar products, upon which Ensemble was built, our app is well-tolerated and impactful for patients.

Data shows that people with MDD are 5.7 times more likely to have GAD than people without MDD.

Additionally, 20% of people with MDD also meet criteria for GAD in a given 12-month period.

Enhanced Care

Ensemble is an investigational medical device and is not intended to replace any other treatment your patients may be receiving, such as medication or talk therapy. Regular assessments, feedback to you, and a wide library of activities and lessons work in concert to help enhance participants’ treatment.

Regular Assessments are Administered to the Participant

Participants are assessed biweekly over the 10-week course of treatment.

Objective Measures are Tracked in a Provider Dashboard

A dashboard provides scores from validated assessment measures in addition to insights about participant engagement and use. This data may be used to further personalize treatment, inform case management, or support claims-based reimbursement.

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 depression and anxiety symptoms.

Please note: Ensemble is a prescription-only, adjunctive digital therapeutic intended to provide evidence-based activities to participants 22 years and older diagnosed with mild, moderate depression or anxiety.