Bold Health's CBT-based IBS Self-Management App Demonstrates Efficacy in Clinical Trial

LONDON, May 20, 2021 /PRNewswire/ -- Bold Health, a digital health company providing integrative virtual care and digital therapies for digestive conditions, announced the results from their randomized controlled trial (RCT) in collaboration with the University of Pennsylvania, on the efficacy of Zemedy, a mobile digital therapeutic for irritable bowel syndrome (IBS). Detailed results of the RCT (N=121) were published in the Journal of Medical Internet Research and showed that patients using Zemedy revealed significant improvements in IBS symptoms, quality of life, and mental health scores compared to the waitlist control group.

"Thanks to this trial, we saw how technological advancement can improve access to effective therapies for chronic conditions that go beyond traditional treatments," says Dr Jossy Onwude, the co-founder and Chief Medical and Product Officer at Bold Health. "Having proved the efficacy of Zemedy for IBS, we can adapt its model for further advancement in the digitally-enabled management of other GI conditions, including IBD and GERD".

Zemedy consists of six modules focusing on psychoeducation, relaxation training, exercise and nutritional information. Its cognitive model of stress management applies CBT to IBS symptoms, reducing avoidance through exposure therapy and behavioral experiments. The app, marked with a 90% digital health assessment score by ORCHA, is based on a Cognitive Behavioral intervention for IBS developed by Dr Melissa Hunt, a clinical psychologist and expert in behavioral interventions for GI conditions at the University of Pennsylvania; and has been adapted by Marie Chellingsworth, a UK-based expert in digital CBT and Clinical Director in the NHS's Improving Access to Psychological Therapies (IAPT) service. The program's specialised toolkit for gut-brain regulation was developed in conjunction with other leading clinical specialists, such as Professor Peter Whorwell, one of the UK's leading IBS specialists in gut-directed hypnotherapy.

"This study is an important addition to the developing evidence base for the efficacy of low-intensity Cognitive Behavioral Therapy treatments for IBS," said Dr Melissa Hunt. "We saw clinically significant improvement in GI symptoms and health-related quality of life for people managing IBS.  Delivering this treatment digitally, Zemedy can dramatically increase the accessibility and affordability of empirically supported CBT for IBS."

In the United States, GI conditions account for $136B in medical claims annually, which is more than mental health or heart disease-related claims. One in seven people suffers from the symptoms of irritable bowel, a disorder tied to depression, anxiety, severe physical pain and bowel movements disruption, while being the second most common cause of work absences. As the most commonly diagnosed digestive disorder, IBS costs an estimated $14 billion in medical claims annually, as well as an additional $28 billion in indirect costs due to work absences and productivity loss.

Despite its relatively benign physical profile, IBS can be a debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase the accessibility of this proven evidence-based treatment.

About the RCT:

This was a cross-over randomized controlled trial with participants recruited online and randomly allocated to either immediate treatment (N = 62) or waitlist control (N = 59). The treatment was fully automated, with no therapist involvement. At baseline and after 8 weeks, participants were asked to complete a battery of primary (IBS Quality of Life (IBS-QoL), Gastrointestinal Symptom Rating Scale (GSRS)) and secondary outcome measures (the Fear of Food Questionnaire (FFQ), the Visceral Sensitivity Index (VSI), the GI Cognition Questionnaire (GI-COG), the Depression and Anxiety Stress Scale (DASS) and the Patient Health Questionnaire (PHQ-9)). Waitlist controls were then offered the opportunity to cross over. All participants were assessed one more time at 3 months post-treatment completion.

About Bold Health:

Bold Health is reimagining the management of chronic GI conditions, offering patients the support of an integrated care team and effective digital therapies to manage symptoms and improve wellbeing. Bold Health works with leading companies and health insurance providers to give people with digestive disorders direct access to the most effective treatments developed with the world's leading academic institutions. Constantly tested in clinical trials, Bold Health's scalable digital solutions have shown to improve symptoms and quality of life while reducing overall healthcare costs.

About University of Pennsylvania:

Penn is one of the world's most powerful research and teaching institutions. The scale and interdisciplinary character of research set Penn apart, and its Department of Psychology is the oldest continuously functioning psychology department in North America.

For further information visit www.zemedy.com

@TryZemedy @BoldHealthHQ

Note to Editors:

Zemedy is the world's first evidence-based program that uses CBT digitally to restore gut-brain connection and help IBS sufferers. A trial V1 of the app was launched in 2019 where users experienced a significant reduction in symptoms, some with no flareups at all.

SOURCE Bold Health