Zemedy Application for Irritable Bowel Syndrome

• ClinicalTrials.gov Identifier: NCT04723056
• Recruitment Status: Recruiting
• First Posted: January 25, 2021
• Last Update Posted: June 1, 2022
• Sponsor: Stanford University
• Collaborator: Bold Health Inc.
• Information provided by (Responsible Party): Linda Nguyen, Stanford University

Study Description

Brief Summary:

The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.

Condition or disease	Intervention/treatment	Phase
IBS - Irritable Bowel Syndrome	Device: Use of Zemedy Application	Not Applicable

Detailed Description:

Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors.

Treatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.

CBT has been shown to reduce the severity of intractable IBS symptoms by as much as 70%. The investigators hope to learn whether the Zemedy mobile application is effective in the reduction of IBS. This will be measured based on their IBS Symptom Severity Scores (SSS) at week 8 compared to baseline.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized trial comparing Zemedy CBT app vs. Treatment as usual
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome
• Actual Study Start Date: October 15, 2021
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control Group (TAU only); Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy.
Experimental: Experimental (TAU plus CBT); Subjects who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU).	Device: Use of Zemedy Application; 8 weeks of CBT via the Zemedy Application.

Outcome Measures

Primary Outcome Measures :

1. IBS-SSS at 8 Weeks [ Time Frame: Baseline and at Week 8. ]
   Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500

Secondary Outcome Measures :

1. IBS-SSS at 24 Weeks [ Time Frame: Baseline and at Week 24. ]
   Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 24 compared to baseline. Score range: 0-500

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male and female patients >=18 years old.
2. Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS.
3. English proficiency (in order to understand use of the application.
4. Patient must be on a stable regimen for IBS for at least 30 days.
5. Patients must own a smartphone (iOS or Android) in order to participate in the CBT application.

Exclusion Criteria:

1. Laboratory or imaging evidence of an alternative explanation of patient's symptoms.
2. Active gastrointestinal disease such as Crohn's disease, ulcerative colitis, history of complete colon resection, acute infection, or any disease that precludes participation in CBT application.
3. Patient already undergoing cognitive behavioral therapy.
4. Psychiatric hospitalization within 10 years.
5. Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse.
6. Active (within the past 3 months) suicidal ideation.
7. Prisoners or other detained individuals.
8. Adults unable to consent.
9. Pregnant people.

Contacts and Locations

Contacts

Contact: Brittany D Marsh, BA; 650-725-9321; brimarsh@stanford.edu

Locations

United States, California

Stanford University School of Medicine; Recruiting

Redwood City, California, United States, 94063

Contact: Britany D Marsh, BA 650-725-9321 brimarsh@stanford.edu

Principal Investigator: Linda Nguyen, MD

Sub-Investigator: Irene Sonu, MD

Sponsors and Collaborators

Stanford University

Bold Health Inc.

Investigators

• Principal Investigator: Linda Nguyen, MD; Stanford University

More Information

• Responsible Party: Linda Nguyen, Clinical Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT04723056
• Other Study ID Numbers: 59209
• First Posted: January 25, 2021
• Last Update Posted: June 1, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Linda Nguyen, Stanford University:

Irritable Bowel Syndrome; Cognitive Behavioral Therapy; Self Help

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases