Bold Health Partners with the University of Pennsylvania for Clinical Trial of Its Zemedy IBS App

The School of Arts and Science of the prestigious University of Pennsylvania invites participants to a waitlist randomised control trial investigating the potential benefits of the Zemedy mobile app in patients with Irritable Bowel Syndrome (IBS).

“We have been tremendously fortunate to partner with Dr Hunt in both creating the innovative intervention based on her research over the years, and to work on validation of the digitised form of the therapy that promises to dramatically increase access to effective IBS treatment.” – Dr. Jossy Onwude, Chief Medical Officer of Bold Health

Zemedy App

The Zemedy app is a self-help, patient-centric digital treatment approach based on research hypotheses about the potency of psychological, empirically supported treatment methods in the management of IBS. The app is designed to deliver a model of treatment based on recent studies in cognitive-behavioral therapy, combined with proven techniques for relaxation, stress management, gut-directed hypnotherapy, and dietary management.

“Acceptability and Efficacy of Zemedy mobile app for Irritable Bowel Syndrome” Trial:

Participants

Eligible participants are IBS patients aged 18 years and over, with a correct diagnosis by a medical professional (and confirmed to have no other associating complications of gastrointestinal disorders). 

Cohorts

All selected patients will be randomly assigned to one of two patient cohorts: the immediate study group and the waitlist group. Patients assigned to the waiting list group will be advised to continue with their current method of symptoms management. 

Intervention

All selected patients on the immediate intervention study group will get a customized email within 24 hours instructing them on how to download the mobile app. They will be asked to complete a series of simple tasks as they work through the app, ranging from tracking their personal IBS symptoms, reading information about IBS, keeping a record of their mental health determinant factors, to learning about the treatment of IBS using dietary and exercise management plans. 

Patients will also be requested to keep a record of their thoughts in situations that reflexively initiate the expression of their IBS symptoms, practice prescribed relaxation exercises, learn innovative ways of rationalizing the impact of IBS symptoms on their social sphere and also abstractly describe their symptoms using imagery, all of which are parts of a Cognitive Behavioral Therapy program specially designed for IBS. Symptoms, severity scores and other bio-psychometric scores will be measured after 8 weeks of intensive treatment with the app, and a final measurement will be taken three months after treatment.

Risks and Benefits  

Investigators have made it clear there is no guarantee of dramatic improvements for participants, and flagged potential risks such as increased symptom awareness and trepidation. There is provision for a licensed clinical psychologist on the research team to support patients.

All submitted patient medical records will be managed confidentially and publications de-identified. In addition to any potential benefits from enrolling in the research study, selected participants will also be compensated with Amazon gift vouchers (worth $40 to $60).

Potential Participants 
Enrolment into the study is currently ongoing: interested participants can visit the research website to apply.

Many thanks to Elena Mustatea for this article

Full press release available here

Check out a related case on MedShr!

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