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Zemedy Application for Irritable Bowel Syndrome

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

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.

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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

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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723056


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

Locations
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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
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Principal Investigator: Linda Nguyen, MD Stanford University
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Responsible Party: Linda Nguyen, Clinical Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04723056    
Other Study ID Numbers: 59209
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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