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Loss of funding
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| Name | Class |
|---|---|
| Bold Health Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (TAU only) | No Intervention | 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 | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of Zemedy Application | Device | 8 weeks of CBT via the Zemedy Application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and at Week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and at Week 24 |
| Hospital Anxiety and Depression Scale (HADS) - Depression Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Nguyen, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Redwood City | California | 94063 | United States |
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21 participants signed informed consent; 18 were randomized to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Control Group (TAU Only) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Participants with data at the respective time point | Posted | Mean | Full Range | score on a scale | Baseline and at Week 8. |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Unrelated to treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Nguyen | Stanford University | 650-736-0431 | nguyenlb@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 | Mar 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Randomized trial comparing Zemedy CBT app vs. Treatment as usual
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Assesses mood measured by the total distress score (score range: 0 to 21; <7 normal, 8-14 borderline, 15 or >15, abnormal). |
| Baseline, week 8 and week 24 |
| 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) | Baseline, week 8 and week 24 |
| 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) | baseline, 24 weeks |
| 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). | Baseline, week 24 |
| 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). | Baseline, Week 24 |
| Work Productivity and Activity Impairment (WPAI) Questionnaire | Assesses work productivity based on percentage of work days taken off due to health | Baseline, 8 weeks, 24 weeks |
| Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | 24 months |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 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). | Participants with data at the respective time point | Posted | Mean | Full Range | score on a scale | Baseline and at Week 24 |
|
|
|
|
| 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). | Participants with data at the respective time point | Posted | Mean | Full Range | score on a scale | Baseline, week 8 and week 24 |
|
|
|
|
| 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) | Participants with data at the respective time point | Posted | Mean | Full Range | score on a scale | Baseline, week 8 and week 24 |
|
|
|
|
| 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) | Participants with data at the respective time point | Posted | Mean | Full Range | score on a scale | baseline, 24 weeks |
|
|
|
|
| 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). | Participants with data at the respective time point | Posted | Mean | Full Range | score on a scale | Baseline, week 24 |
|
|
|
|
| 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). | Participants with data at the respective time point | Posted | Mean | Full Range | score on a scale | Baseline, Week 24 |
|
|
|
|
| Secondary | Work Productivity and Activity Impairment (WPAI) Questionnaire | Assesses work productivity based on percentage of work days taken off due to health | Participants with data at the respective time point | Posted | Mean | Standard Deviation | percentage of work time missed | Baseline, 8 weeks, 24 weeks |
|
|
|
|
| Secondary | Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS | Posted | Count of Participants | Participants | 24 months |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D004066 | Digestive System Diseases |
| Week 24 |
|
|
| Week 8 |
|
|
| Week 24 |
|
|
| t-test, 2 sided |
| 0.179 |
The a priori threshold for statistical significance was <0.05. |
| Other |
| Week 8 |
|
|
| Week 24 |
|
|
| t-test, 2 sided |
| .606 |
The a priori threshold for statistical significance was <0.05. |
| Other |
| Week 24 |
|
|
| Week 24 |
|
|
| Week 24 |
|
|
| Week 8 |
|
|
| Week 24 |
|
|
| t-test, 2 sided |
| .707 |
The a priori threshold for statistical significance was <0.05. |
| Other |
| Physician appointment |
|