IBS - Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Self Help
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.
Interventions
DEVICEUse of Zemedy Application
8 weeks of CBT via the Zemedy Application.
Sponsors
Bold Health Inc.
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized trial comparing Zemedy CBT app vs. Treatment as usual
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS-SSS at 8 Weeks | Baseline and at Week 8. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) - Depression Score | Baseline, week 8 and week 24 | Assesses mood measured by the total distress score (score range: 0 to 21; \<7 normal, 8-14 borderline, 15 or \>15, abnormal). |
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Baseline, week 8 and week 24 | Assesses mood measured by the total distress score (score range: 0 to 21; \<7 normal, 8-14 borderline, 15 or \>15, abnormal) |
| Cohen Perceived Stress Questionnaire (PSQ) | baseline, 24 weeks | Measures degree situation's in one's life are seen as stressful (score range: 0 to 40; 0-13 = low stress, 14-26 = moderate stress, 27-40 = high stress) |
| IBS-SSS at 24 Weeks | Baseline and at Week 24 | 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. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; \>300 = severe). |
| Subject's Global Assessment of Relief (SGA) | Baseline, Week 24 | Assesses global symptoms relief asking the question, Overall, how do you feel?. Score range: -2 (no pain) to +2 (severe pain/discomfort). |
| Work Productivity and Activity Impairment (WPAI) Questionnaire | Baseline, 8 weeks, 24 weeks | Assesses work productivity based on percentage of work days taken off due to health |
| Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | 24 months | — |
| Work and Social Adjustment Scale (WSAS) | Baseline, week 24 | Measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. Score range: 0 to 40 (\<10 subclinical/mild, 10-20 significant, \>20 severe). |
Countries
United States
Participant flow
Pre-assignment details
21 participants signed informed consent; 18 were randomized to a study arm.
Participants by arm
| Arm | Count |
|---|---|
| Experimental (TAU Plus CBT) Participants 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). | 9 |
| Control Group (TAU Only) 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. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Experimental (TAU Plus CBT) | Control Group (TAU Only) | Total |
|---|---|---|---|
| Age, Continuous | 36 years | 34 years | 35.5 years |
| Race/Ethnicity, Customized Non-white | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 7 Participants | 16 Participants |
| Region of Enrollment United States | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 1 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
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. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; \>300 = severe).
Time frame: Baseline and at Week 8.
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental (TAU Plus CBT) | IBS-SSS at 8 Weeks | Week 8 | 126 score on a scale |
| Experimental (TAU Plus CBT) | IBS-SSS at 8 Weeks | Baseline | 215 score on a scale |
| Control Group (TAU Only) | IBS-SSS at 8 Weeks | Baseline | 171 score on a scale |
| Control Group (TAU Only) | IBS-SSS at 8 Weeks | Week 8 | 143.5 score on a scale |
Comparison: Between-group analysis at week 8p-value: 0.282t-test, 2 sided
Secondary
Cohen Perceived Stress Questionnaire (PSQ)
Measures degree situation's in one's life are seen as stressful (score range: 0 to 40; 0-13 = low stress, 14-26 = moderate stress, 27-40 = high stress)
Time frame: baseline, 24 weeks
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental (TAU Plus CBT) | Cohen Perceived Stress Questionnaire (PSQ) | Baseline | 32 score on a scale |
| Experimental (TAU Plus CBT) | Cohen Perceived Stress Questionnaire (PSQ) | Week 24 | 29 score on a scale |
| Control Group (TAU Only) | Cohen Perceived Stress Questionnaire (PSQ) | Baseline | 21 score on a scale |
| Control Group (TAU Only) | Cohen Perceived Stress Questionnaire (PSQ) | Week 24 | 22 score on a scale |
Comparison: Between-group analysis at week 24p-value: 0.181t-test, 2 sided
Secondary
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Assesses mood measured by the total distress score (score range: 0 to 21; \<7 normal, 8-14 borderline, 15 or \>15, abnormal)
Time frame: Baseline, week 8 and week 24
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental (TAU Plus CBT) | Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Baseline | 10 score on a scale |
| Experimental (TAU Plus CBT) | Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Week 24 | 8 score on a scale |
| Experimental (TAU Plus CBT) | Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Week 8 | 9 score on a scale |
| Control Group (TAU Only) | Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Baseline | 7 score on a scale |
| Control Group (TAU Only) | Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Week 8 | 8 score on a scale |
| Control Group (TAU Only) | Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | Week 24 | 6.5 score on a scale |
Comparison: Between-group analysis at week 8p-value: 0.573t-test, 2 sided
Comparison: Between-group analysis at week 24p-value: 0.606t-test, 2 sided
Secondary
Hospital Anxiety and Depression Scale (HADS) - Depression Score
Assesses mood measured by the total distress score (score range: 0 to 21; \<7 normal, 8-14 borderline, 15 or \>15, abnormal).
Time frame: Baseline, week 8 and week 24
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental (TAU Plus CBT) | Hospital Anxiety and Depression Scale (HADS) - Depression Score | Baseline | 6 score on a scale |
| Experimental (TAU Plus CBT) | Hospital Anxiety and Depression Scale (HADS) - Depression Score | Week 8 | 7 score on a scale |
| Experimental (TAU Plus CBT) | Hospital Anxiety and Depression Scale (HADS) - Depression Score | Week 24 | 5 score on a scale |
| Control Group (TAU Only) | Hospital Anxiety and Depression Scale (HADS) - Depression Score | Baseline | 2 score on a scale |
| Control Group (TAU Only) | Hospital Anxiety and Depression Scale (HADS) - Depression Score | Week 8 | 5 score on a scale |
| Control Group (TAU Only) | Hospital Anxiety and Depression Scale (HADS) - Depression Score | Week 24 | 1.5 score on a scale |
Comparison: Between-group analysis at week 8p-value: 0.462t-test, 2 sided
Comparison: Between-group analysis at week 24p-value: 0.179t-test, 2 sided
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. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; \>300 = severe).
Time frame: Baseline and at Week 24
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental (TAU Plus CBT) | IBS-SSS at 24 Weeks | Baseline | 215 score on a scale |
| Experimental (TAU Plus CBT) | IBS-SSS at 24 Weeks | Week 24 | 134 score on a scale |
| Control Group (TAU Only) | IBS-SSS at 24 Weeks | Baseline | 171 score on a scale |
| Control Group (TAU Only) | IBS-SSS at 24 Weeks | Week 24 | 143.5 score on a scale |
Comparison: Between-group analysis at week 24p-value: 0.217t-test, 2 sided
Secondary
Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS
Time frame: 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental (TAU Plus CBT) | Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | Urgent care | 0 Participants |
| Experimental (TAU Plus CBT) | Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | Emergency Department | 1 Participants |
| Experimental (TAU Plus CBT) | Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | Physician appointment | 0 Participants |
| Control Group (TAU Only) | Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | Urgent care | 0 Participants |
| Control Group (TAU Only) | Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | Emergency Department | 0 Participants |
| Control Group (TAU Only) | Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | Physician appointment | 0 Participants |
Secondary
Subject's Global Assessment of Relief (SGA)
Assesses global symptoms relief asking the question, Overall, how do you feel?. Score range: -2 (no pain) to +2 (severe pain/discomfort).
Time frame: Baseline, Week 24
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental (TAU Plus CBT) | Subject's Global Assessment of Relief (SGA) | Baseline | 0 score on a scale |
| Experimental (TAU Plus CBT) | Subject's Global Assessment of Relief (SGA) | Week 24 | 0 score on a scale |
| Control Group (TAU Only) | Subject's Global Assessment of Relief (SGA) | Baseline | 1 score on a scale |
| Control Group (TAU Only) | Subject's Global Assessment of Relief (SGA) | Week 24 | 1.5 score on a scale |
Comparison: Between-group analysis at week 24p-value: 0.643t-test, 2 sided
Secondary
Work and Social Adjustment Scale (WSAS)
Measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. Score range: 0 to 40 (\<10 subclinical/mild, 10-20 significant, \>20 severe).
Time frame: Baseline, week 24
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental (TAU Plus CBT) | Work and Social Adjustment Scale (WSAS) | Baseline | 14 score on a scale |
| Experimental (TAU Plus CBT) | Work and Social Adjustment Scale (WSAS) | Week 24 | 9 score on a scale |
| Control Group (TAU Only) | Work and Social Adjustment Scale (WSAS) | Baseline | 13 score on a scale |
| Control Group (TAU Only) | Work and Social Adjustment Scale (WSAS) | Week 24 | 14.5 score on a scale |
Comparison: Between-group analysis at week 24p-value: 0.407t-test, 2 sided
Secondary
Work Productivity and Activity Impairment (WPAI) Questionnaire
Assesses work productivity based on percentage of work days taken off due to health
Time frame: Baseline, 8 weeks, 24 weeks
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental (TAU Plus CBT) | Work Productivity and Activity Impairment (WPAI) Questionnaire | Week 8 | 2.6 percentage of work time missed | Standard Deviation 4.1 |
| Experimental (TAU Plus CBT) | Work Productivity and Activity Impairment (WPAI) Questionnaire | Week 24 | 1.4 percentage of work time missed | Standard Deviation 1.8 |
| Experimental (TAU Plus CBT) | Work Productivity and Activity Impairment (WPAI) Questionnaire | Baseline | 9.59 percentage of work time missed | Standard Deviation 6.06 |
| Control Group (TAU Only) | Work Productivity and Activity Impairment (WPAI) Questionnaire | Week 8 | 1.5 percentage of work time missed | Standard Deviation 3.3 |
| Control Group (TAU Only) | Work Productivity and Activity Impairment (WPAI) Questionnaire | Baseline | 3.57 percentage of work time missed | Standard Deviation 4.65 |
| Control Group (TAU Only) | Work Productivity and Activity Impairment (WPAI) Questionnaire | Week 24 | 0.96 percentage of work time missed | Standard Deviation 1.9 |
Comparison: Between-group analysis at week 8p-value: 0.625t-test, 2 sided
Comparison: Between-group analysis at week 24p-value: 0.707t-test, 2 sided