Digital therapeutics (DTx) continue to rise in prevalence and scientific efficacy. While technology is nothing new in healthcare and medicine, DTx generally refers to the more recent application of digital tools to deliver some kind of therapeutic intervention. These technologies can take many forms, but they often involve apps of some kind.
Many DTx’s target mental illnesses, like depression and anxiety. These tools often use principles common in traditional therapy, such as cognitive behavioral therapy, to help users change behaviors. Through the use of games and mindfulness strategies, for example, many DTx have proved effective at helping reduce the signs and symptoms of particular mental illnesses.
Researchers are also looking at how these digital therapies can target not just mental illnesses like anxiety and depression, but physical illnesses as well (for example, Happify Health has shown its own DTx app is helpful at reducing stress and anxiety, which correlated to a reduction in migraines among users).
A new DTx from MetaMe, called Regulora, has recently received FDA approval as a DTx for the management of pain caused by irritable bowel syndrome (IBS). MetaMe Health is a company that focuses on the development of digital therapeutics specifically for gut health, focusing on a psychological treatment for the management of pain.
So how does Regulora work?
Regulora uses many of the principles of many other DTx by targeting psychological symptoms that may be causing physical ailments. Regulora specifically targets the connection between the brain and the gut, which may help alleviate IBS pain or help make it more manageable for patients. Regulora specifically is designed to deliver self-directed, gut-directed hypnotherapy (GDH) remotely via seven, 30-minute “sessions.”
GDH is essentially the use of hypnosis to influence the “brain-gut axis,” or the connection between the brain and the gut to psychologically influence feelings of pain, bloating, or other symptoms of IBS. In the past, GDH has been used for the management of pain for IBS patients, but it can only be delivered by a specially trained doctor in a clinic setting. The COVID-19 pandemic made this treatment even more inaccessible.
The FDA provided approval of the app after a 12-week randomized trial of about 360 participants. Participants showed significant improvement in abdominal pain during the last 4 weeks of treatment, though the difference between treatment and control group after the treatment period in change of abdominal pain was not statistically significant.