Zemedy Application for Irritable Bowel Syndrome

IBS - Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04723056
• Other study ID #: 59209
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: March 2024

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• Use of Zemedy Application
8 weeks of CBT via the Zemedy Application.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Bold Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and at Week 8.
Secondary	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	Baseline and at Week 24.