Bold Health, a London-based company developing digital therapeutics for gastrointestinal conditions, is backing a new University of Pennsylvania-led study that will directly compare the company's cognitive behavior therapy (CBT) app for irritable bowel syndrome (IBS) to Headspace's consumer mindfulness and meditation app.
According to a clinicaltrials.gov listing spotted by Exits & Outcomes, researchers will be randomly assigning 300 participants with IBS to receive either Bold Health's Zemedy app or the Headspace mindfulness app for free. Each group will have the app for eight weeks, after which those who received the Headspace app will also be given access to Zemedy.
At baseline and after those eight weeks, the researchers will administer a battery of questionnaires, and those who switched from Headspace to Zemedy will receive a third slew of questions after an additional eight weeks with Bold Health's app. Finally, participants in both groups will be contacted three months after treatment for a follow-up questionnaire.
Through these surveys, the researchers will be comparing responses regarding the study's primary outcomes: IBS quality of life, and the severity of their gastrointestinal symptoms. Secondary outcomes include respondents' scores on various gastrointestinal-related measurements, including their anxiety regarding visceral gut sensations, fear of food or eating, and impairments to their work due to health conditions.
The "Acceptability and Efficacy of Zemedy App Versus Headspace App for IBS" study is estimated to start January 4, 2021 and complete by May 28, 2023, according to the listing. It is enrolling adults aged 18 years or older who self-report a physician diagnosis of IBS.
WHY IT MATTERS
IBS is prevalent, affecting between 25 million and 45 million people in the U.S. according to the International Foundation for Gastrointestinal Disorders. A body of research has developed over the years regarding the "brain-gut axis," in which behavioral health treatments such as CBT can lessen the impact of IBS symptoms.
Bold Health has made its case for IBS CBT therapy in the past. The company previously worked with both Charité-Universitätsmedizin Berlin and UPenn (specifically, returning principal investigator Melissa Hunt) on clinical studies exploring app-delivered CBT for gastrointestinal conditions. The company also released the Zemedy app on the App Store to collect real-world evidence for later publication.
With this trial, however, Bold Health is making the case that Zemedy, which is branded as a digital therapeutic, will be demonstrably more effective than a corresponding consumer wellness app. Results suggesting otherwise – or even data describing the two apps' impacts as similar – would put Bold Health in the awkward position of justifying the product over its well-established, consumer-friendly competitor.
THE LARGER TREND
Publication of the clinicaltrials.gov listing comes shortly after Mahana Therapeutics, a San Francisco-based company developing prescription digital therapeutics for gastrointestinal conditions, received a De Novo clearance for Parallel. Much like Zemedy, this app (prescribed alongside other medications) uses digital CBT to help patients manage their IBS.
Meanwhile Pear Therapeutics, a well-known name in the budding prescription digital therapeutics space, also lists an IBS-focused candidate in its product pipeline.