FDA Approves Digital CBT Treatment for IBS

The U.S. Food and Drug Administration (FDA) has granted De Novo approval to ParallelTM, a new prescription-only digital program for irritable bowel syndrome (IBS). The program lasts for 3 months and uses cognitive behavioral therapy (CBT) to help reduce IBS symptoms. Parallel is approved for people 22 years and older who have IBS.1

How does Parallel work?

It has been thought that the human brain and gut are highly connected. Some have suggested that the way we feel mentally may impact our digestion. For example, when many of us are nervous or anxious, we may also have a nervous stomach or changes in bowel movements.2

Parallel builds on this potential connection. It is a 3-month digital program (an app) that provides the user with virtual CBT therapy. CBT is a type of psychological treatment normally given by a therapist. CBT focuses on reframing emotions or beliefs and building coping strategies. Parallel provides personalized feedback to each user by tracking symptoms and mental health alongside physical health. It also helps with building new habits and developing skills related to managing IBS.1,2

What is a De Novo authorization?

De Novo approvals are for new medical devices. Just like new drugs, medical devices need to be evaluated by the FDA for quality and safety. De Novo approvals are specifically for medical devices that are unique, meaning no other similar device exists. This program allows the makers of a new device to provide data from clinical trials to the FDA in exchange for permission to start selling the device to those in need. It provides a pathway for new, promising devices to make their way to market quickly.3

Why is this an important approval for people with IBS?

Research shows that most people in the United States with IBS feel they either have no control or inadequate control of their symptoms. As researchers learn more about the connection between the brain and the gut, it has become more common for CBT and other psychological treatments to be part of care plans for people with IBS. Parallel offers people with IBS a new option to better manage their symptoms.4

Evidence for Parallel

Two studies that focus on Parallel have been published. Both were published in 2019 and compared the effects of Parallel, telephone-delivered CBT with a live therapist, and traditional treatment as usual without CBT. Those with refractory IBS (IBS that persisted despite treatment for more than a year) were included in the study.5,6

Both physical symptoms and work/social impacts were evaluated. In the first study, compared with traditional treatment options alone, both forms of CBT (telephone and Parallel online) provided greater symptom improvement after 12-months of follow-up. Similar to physical symptoms, both CBT groups had greater improvements in overall work and social functioning 12-months after treatment. In the second study, the same results were found at the 24-month follow-up mark.5,6

Even though both CBT groups saw benefits, the group with the telephone-delivered CBT had the greatest improvements overall. For this reason, the makers of Parallel do not suggest that the digital program completely replace traditional, live CBT. Instead, they suggest that it might be a good add-on option or be helpful for those without access to therapy.

None of the participants in either study reported side effects related to the Parallel device.

Things to consider

Parallel is not a stand-alone treatment. It is meant to be used alongside other traditional treatment options. It is also not meant to be used in emergency situations or as a substitute for seeing your regular healthcare provider.2

People using Parallel must be able to read and understand English, have a desktop or laptop computer with a web browser and internet connectivity. They should also be familiar with how to use web applications.2

For more information, read the full patient information for Parallel.

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