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Zemedy Application for Irritable Bowel Syndrome

Primary Purpose

IBS - Irritable Bowel Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Use of Zemedy Application

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Self Help

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group (TAU only)

Experimental (TAU plus CBT)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04723056

First Posted

January 20, 2021

Last Updated

May 26, 2022

Sponsor

Stanford University

Collaborators

Bold Health Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04723056

Brief Title

Zemedy Application for Irritable Bowel Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2021 (Actual)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Bold Health Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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.

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IBS - Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Self Help

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized trial comparing Zemedy CBT app vs. Treatment as usual

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group (TAU only)

Arm Type

No Intervention

Arm Description

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.

Arm Title

Experimental (TAU plus CBT)

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Use of Zemedy Application

Intervention Description

8 weeks of CBT via the Zemedy Application.

Primary Outcome Measure Information:

Title

IBS-SSS at 8 Weeks

Description

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

Time Frame

Baseline and at Week 8.

Secondary Outcome Measure Information:

Title

IBS-SSS at 24 Weeks

Description

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

Time Frame

Baseline and at Week 24.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brittany D Marsh, BA

Phone

650-725-9321

brimarsh@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Nguyen, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Britany D Marsh, BA

Phone

650-725-9321

brimarsh@stanford.edu

First Name & Middle Initial & Last Name & Degree

Linda Nguyen, MD

First Name & Middle Initial & Last Name & Degree

Irene Sonu, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Zemedy Application for Irritable Bowel Syndrome

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