Zemedy Application for Irritable Bowel Syndrome

Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome

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.

Study Overview

• Status: Terminated
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Device: Use of Zemedy Application

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-SSS at 8 Weeks	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. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; >300 = severe).	Baseline and at Week 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-SSS at 24 Weeks	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. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; >300 = severe).	Baseline and at Week 24
Hospital Anxiety and Depression Scale (HADS) - Depression Score	Assesses mood measured by the total distress score (score range: 0 to 21; <7 normal, 8-14 borderline, 15 or >15, abnormal).	Baseline, week 8 and week 24
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score	Assesses mood measured by the total distress score (score range: 0 to 21; <7 normal, 8-14 borderline, 15 or >15, abnormal)	Baseline, week 8 and week 24
Cohen Perceived Stress Questionnaire (PSQ)	Measures degree situation's in one's life are seen as stressful (score range: 0 to 40; 0-13 = low stress, 14-26 = moderate stress, 27-40 = high stress)	baseline, 24 weeks
Work and Social Adjustment Scale (WSAS)	Measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. Score range: 0 to 40 (<10 subclinical/mild, 10-20 significant, >20 severe).	Baseline, week 24
Subject's Global Assessment of Relief (SGA)	Assesses global symptoms relief asking the question, "Overall, how do you feel?". Score range: -2 (no pain) to +2 (severe pain/discomfort).	Baseline, Week 24
Work Productivity and Activity Impairment (WPAI) Questionnaire	Assesses work productivity based on percentage of work days taken off due to health	Baseline, 8 weeks, 24 weeks
Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS		24 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Bold Health Inc.
• Investigators: Principal Investigator: Linda Nguyen, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): March 8, 2024

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Cognitive Behavioral Therapy; Self Help
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Disease; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Syndrome
• Other Study ID Numbers: 59209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No