Happify Health announced the launch of Ensemble, a transdiagnostic prescription digital therapeutic for the treatment of patients 22 years of age and older with major depressive disorder (MDD) or generalized anxiety disorder (GAD).

Ensemble is an AI-powered digital mental health coach app designed to address the symptoms of MDD or GAD through activities based on cognitive behavioral therapy, mindfulness, and positive psychology. Mental health improvements are measured using clinically validated instruments (Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7). Ensemble also includes a physician dashboard for patient monitoring.

According to the Company, treatment with Ensemble was found to be superior to placebo for reducing anxiety symptoms and depression in patients experiencing distressing symptoms at baseline.

The digital therapeutic should be used under the supervision of a health care provider and as an adjunct to treatment for depression or anxiety. It is not intended to be used as a standalone therapy and has not been cleared by the Food and Drug Administration (FDA).


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Patients should not use Ensemble if they have been diagnosed with post-traumatic stress disorder, psychotic disorder, schizophrenia, bipolar disorder, anorexia nervosa, borderline personality disorder, traumatic brain injury, and/or dementia or other neurocognitive disorder.

Ensemble is available only by prescription via smartphone or computer. The investigational device was released under the FDA’s Enforcement policy.

References

  1. Happify launches the first prescription digital therapeutics to treat both MDD and GAD. News release. Happify Health. Accessed July 22, 2021. https://www.businesswire.com/news/home/20210722005410/en/Happify-Launches-the-First-Prescription-Digital-Therapeutics-to-Treat-Both-MDD-and-GAD
  2. The Science. Ensemble by Happify Health. Accessed July 22, 2021. https://www.getensemble.com/public/ensemble-science/index.html.