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Behavioural Intervention
Use of Zemedy Application for Irritable Bowel Syndrome
N/A
Waitlist Available
Led By Linda Nguyen, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at week 24.
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether the Zemedy app can help people with IBS by providing a CBT program digitally.
Who is the study for?
This trial is for adults over 18 with Irritable Bowel Syndrome (IBS) who have had symptoms for at least 6 months. Participants must speak English, have been on a stable IBS treatment for 30 days, and own a smartphone to use the Zemedy app.
What is being tested?
The study tests the effectiveness of Zemedy, a mobile app delivering cognitive behavioral therapy (CBT) programs to help manage IBS symptoms.
What are the potential side effects?
Since Zemedy is an application providing CBT and not a medication, it may not have typical drug side effects. Users might experience discomfort if new to CBT or stress from regular engagement with the program.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with IBS for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at week 24.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at week 24.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
IBS-SSS at 8 Weeks
Secondary study objectives
IBS-SSS at 24 Weeks
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental (TAU plus CBT)Experimental Treatment1 Intervention
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).
Group II: Control Group (TAU only)Active Control1 Intervention
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.
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Who is running the clinical trial?
Bold Health Inc.Industry Sponsor
2 Previous Clinical Trials
599 Total Patients Enrolled
2 Trials studying Irritable Bowel Syndrome
599 Patients Enrolled for Irritable Bowel Syndrome
Stanford UniversityLead Sponsor
2,468 Previous Clinical Trials
17,496,260 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
244 Patients Enrolled for Irritable Bowel Syndrome
Linda Nguyen, MDPrincipal InvestigatorStanford University
5 Previous Clinical Trials
644 Total Patients Enrolled
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