Clinical trial NCT04723056: 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
Overall status: TERMINATED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Cognitive Behavioral Therapy
Self Help
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Bold Health Inc.
First posted: 2021-01-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial comparing Zemedy CBT app vs. Treatment as usual
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IBS-SSS at 8 Weeks
timeFrame: Baseline and at Week 8.
Secondary outcomes:
measure: IBS-SSS at 24 Weeks
timeFrame: Baseline and at Week 24
measure: Hospital Anxiety and Depression Scale (HADS) - Depression Score
timeFrame: Baseline, week 8 and week 24
measure: Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
timeFrame: Baseline, week 8 and week 24
measure: Cohen Perceived Stress Questionnaire (PSQ)
timeFrame: baseline, 24 weeks
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline, week 24
measure: Subject's Global Assessment of Relief (SGA)
timeFrame: Baseline, Week 24
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: Baseline, 8 weeks, 24 weeks
measure: Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS
timeFrame: 24 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Linda Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: