Almee™ (an investigational medical device in clinical development) is a digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) created to address the psychological impact of living with pulmonary fibrosis.
Anxiety is a common symptom in pulmonary fibrosis, with the proportion of patients estimated to be 63%. A US claims analysis reveals that 31% of patients with pulmonary fibrosis and 39% of patients with Idiopathic Pulmonary Fibrosis are prescribed medications for anxiety or depression.
Almee™ is intended to be used in addition to other treatment modalities for pulmonary fibrosis and is not intended to treat the physical aspects of pulmonary fibrosis.
The therapy will be delivered in a sequence of interactive neurobehavioral modules of interventions, patient education, and skill-building, and consists of sound exercises, videos, and interactive exercises as part of the CBT toolbox. Cognitive behavioral therapy (CBT) is a well-established method to support patients who carry a high psychological burden caused by severe disease. Digital CBT is delivered via a software application on a patient’s mobile device, can be personalized and is accessible round-the-clock to meet the patient’s individual needs and schedule.
The COMPANION investigation is being conducted in the US and aims to include 250 patients with anxiety related to pulmonary fibrosis. It is a 8 to 10 week, randomized, controlled, fully virtual and decentralized clinical investigation to evaluate the impact of digital CBT on psychological symptom burden and quality of life in adults living with pulmonary fibrosis.
People who are interested may visit www.vicorecompanionstudy.com – the COMPANION investigation website – where people living with pulmonary fibrosis can answer a few questions to check eligibility.
Almee™ is developed in collaboration with Alex Therapeutics – a digital therapeutics (DTx) company partnering with pharmaceutical companies to create and license digital therapies.