Zemedy Application for Irritable Bowel Syndrome

NCT04723056 | Terminated Results FDA Device

• 1 other identifier: 59209
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Cognitive Behavioral Therapy; Self Help

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• IBS-SSS at 24 Weeks

  Baseline and at Week 24

• Hospital Anxiety and Depression Scale (HADS) - Depression Score

  Baseline, week 8 and week 24

• Hospital Anxiety and Depression Scale (HADS) - Anxiety Score

  Baseline, week 8 and week 24

• Cohen Perceived Stress Questionnaire (PSQ)

  baseline, 24 weeks

• Work and Social Adjustment Scale (WSAS)

  Baseline, week 24

Study Arms (2)

Control Group (TAU only)

NO 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.

Experimental (TAU plus CBT)

EXPERIMENTAL

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

Interventions

Use of Zemedy Application DEVICE

8 weeks of CBT via the Zemedy Application.

Experimental (TAU plus CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Laboratory or imaging evidence of an alternative explanation of patient's symptoms.
• 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.
• Patient already undergoing cognitive behavioral therapy.
• Psychiatric hospitalization within 10 years.
• Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse.
• Active (within the past 3 months) suicidal ideation.
• Prisoners or other detained individuals.
• Adults unable to consent.
• Pregnant people.

Sponsors & Collaborators

• Stanford University: lead
• Bold Health Inc.: collaborator

Study Sites (1)

Stanford University School of Medicine

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Linda Nguyen
• Organization: Stanford University

nguyenlb@stanford.edu

650-736-0431

Study Officials

• Linda Nguyen, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized trial comparing Zemedy CBT app vs. Treatment as usual

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: October 15, 2021
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)