London-based digital health company Bold Health is developing digital therapeutics for gastrointestinal conditions. The company 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, reports MobiHealthNews.
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.
Chronic digestive problems are common and often connected to poor mental wellbeing. Through Bold Health’s digital applications, patients get access to cognitive behavioral therapy (CBT) programs designed for their specific condition.
Zemedy’s 6-week program is designed around core cognitive behavioral therapy (CBT) principles. IBS symptoms are often exacerbated due to stress and anxiety.
The aim of the Zemedy program is to help users target symptoms and difficult emotions by changing the surrounding thoughts and behaviors. Users can practice these techniques in their own safe spaces and learn how to manage their symptoms in the long term.
After eight weeks of the trial, 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, the MobiHealthNews report said.
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.
With this new trial, 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.