Zemedy Application for Irritable Bowel Syndrome

Stanford University

Status: Terminated

Conditions: IBS - Irritable Bowel Syndrome

Treatments: Device: Use of Zemedy Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04723056

59209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Control Group (TAU only)

No Intervention group

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.

Experimental (TAU plus CBT)

Experimental group

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).

Treatment:

Device: Use of Zemedy Application