Bold Health Partners with the University of Pennsylvania for Clinical Trial of Its Zemedy IBS App
London, United Kingdom, November 13, 2019 --(PR.com)-- The School of Arts and Science of the prestigious University of Pennsylvania has tendered a public invitation for suitable individuals to participate in a waitlist randomised control trial aimed at investigating the potential benefits of the Zemedy mobile app in patients with Irritable Bowel Syndrome. 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 Irritable Bowel Syndrome (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.
Screening for participant eligibility
The research study "Acceptability and Efficacy of Zemedy mobile app for IBS" is designed for 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). Eligibility for the study is at the sole discretion of the research investigators who will directly contact selected patients after carefully reviewing entry questionnaires designed to clarify their IBS status in terms of severity, impact on daily life, mental health and healthy living. Patients are also at liberty to skip any questions if they’re inconvenienced.
The study will involve two patient cohorts
All selected patients will be randomly assigned to one of two groups: the immediate study group and the waitlist group.
Patients assigned to the waiting list will be advised to initially continue with their current method of symptoms management and will complete the first batch of symptoms severity measurement as with patients on the immediate treatment list. Treatment for a patient on this list is modeled after the design for patients on the immediate treatment list.
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. All assigned tasks will be fashioned in accordance with the patients' baseline demographic information as supplied.
“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
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 biopsychometric scores will be measured after 8 weeks of intensive treatment with the app, and a final measurement will be taken three months after treatment.
Clarity for patients about risks and benefits - and support available
As in every clinical research study, the investigators have made it clear there is no guarantee of dramatic improvements for participants, and flagged potential risks. Patients can become increasingly aware of their IBS symptoms and physical sensations accompanying them. Patients may also experience disturbing episodes of trepidation while vividly describing impacts of IBS symptoms on their social life, or while completing the tasks prescribed during the course of therapy. However, there is provision for a licensed clinical psychologist on the research team to contact any patients who flag that they are struggling with depression as they take part in the study, and help make referrals to local mental health counselors if desired.
Patient records will be handled confidentially
All submitted patient medical records will be managed confidentially, and personal identification records will be stripped off any future publications to protect patients’ identity. In addition to any potential benefits from enrolling for the research study, selected participants will also be compensated with Amazon gift vouchers worth $40 to $60 depending on the number of questionnaires filled out.
Enrollment into the study is currently ongoing as interested participants can visit the research website and apply to take part.
Screening for participant eligibility
The research study "Acceptability and Efficacy of Zemedy mobile app for IBS" is designed for 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). Eligibility for the study is at the sole discretion of the research investigators who will directly contact selected patients after carefully reviewing entry questionnaires designed to clarify their IBS status in terms of severity, impact on daily life, mental health and healthy living. Patients are also at liberty to skip any questions if they’re inconvenienced.
The study will involve two patient cohorts
All selected patients will be randomly assigned to one of two groups: the immediate study group and the waitlist group.
Patients assigned to the waiting list will be advised to initially continue with their current method of symptoms management and will complete the first batch of symptoms severity measurement as with patients on the immediate treatment list. Treatment for a patient on this list is modeled after the design for patients on the immediate treatment list.
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. All assigned tasks will be fashioned in accordance with the patients' baseline demographic information as supplied.
“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
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 biopsychometric scores will be measured after 8 weeks of intensive treatment with the app, and a final measurement will be taken three months after treatment.
Clarity for patients about risks and benefits - and support available
As in every clinical research study, the investigators have made it clear there is no guarantee of dramatic improvements for participants, and flagged potential risks. Patients can become increasingly aware of their IBS symptoms and physical sensations accompanying them. Patients may also experience disturbing episodes of trepidation while vividly describing impacts of IBS symptoms on their social life, or while completing the tasks prescribed during the course of therapy. However, there is provision for a licensed clinical psychologist on the research team to contact any patients who flag that they are struggling with depression as they take part in the study, and help make referrals to local mental health counselors if desired.
Patient records will be handled confidentially
All submitted patient medical records will be managed confidentially, and personal identification records will be stripped off any future publications to protect patients’ identity. In addition to any potential benefits from enrolling for the research study, selected participants will also be compensated with Amazon gift vouchers worth $40 to $60 depending on the number of questionnaires filled out.
Enrollment into the study is currently ongoing as interested participants can visit the research website and apply to take part.
Contact
Bold Health
Dr. Jossy Onwude
+447340147413
www.bold.health
Dr. Jossy Onwude
+447340147413
www.bold.health
Contact
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