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| Name | Class |
|---|---|
| Bold Health Inc. | INDUSTRY |
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The purpose of this research is to assess if a new self-help app for IBS is an acceptable and effective intervention for improving the overall quality of life in patients with Irritable Bowel Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment | Experimental | Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace. |
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| Waitlist Control | No Intervention | Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zemedy App for Irritable Bowel Syndrome | Behavioral | The Zemedy App for irritable bowel syndrome is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS. |
| Measure | Description | Time Frame |
|---|---|---|
| Irritable Bowel Syndrome Quality of Life | A self-report measure of health related quality of life (HRQL) in people with irritable bowel syndrome. Scores range from 0 to 100. Higher scores are a worse outcome. | 8 weeks |
| Gastrointestinal Symptom Rating Scale | a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral Sensitivity Index | self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome. | 8 weeks |
| GI Cognitions Questionnaire | self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa G Hunt, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-6018 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33872182 | Derived | Hunt M, Miguez S, Dukas B, Onwude O, White S. Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 20;9(5):e26152. doi: 10.2196/26152. |
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146 potential participants were consented and screened. 25 individuals met exclusion criteria (severe depression) and were not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Treatment | Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace. Zemedy App for IBS: The Zemedy App for IBS is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS. |
| FG001 | Waitlist Control | Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
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| Randomization and Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Treatment | Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace. Zemedy App for IBS: The Zemedy App for IBS is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Irritable Bowel Syndrome Quality of Life | A self-report measure of health related quality of life (HRQL) in people with irritable bowel syndrome. Scores range from 0 to 100. Higher scores are a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
1 year
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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 | Immediate Treatment | Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace. Zemedy App for IBS: The Zemedy App for IBS is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS. |
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As is the case with most internet trials we experienced significant attrition from both arms. In the final publication, multiple imputation will be used to account for missing data and both treatment completer and intent-to-treat results will be reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa G. Hunt | University of Pennsylvania | 610-529-8055 | mhunt@psych.upenn.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2019 | Jan 28, 2021 | Prot_001.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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|
| 8 weeks |
| Fear of Food Questionnaire | self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome. | 8 weeks |
| Patient Health Questionnaire | self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome. | 8 weeks |
| Depression Anxiety and Stress Scale - Depression Subscale | Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome. | 8 weeks |
| Depression Anxiety and Stress Scale - Stress Subscale | The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity. | 8 weeks |
| Depression Anxiety and Stress Scale - Anxiety Subscale | Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety. | 8 weeks |
| NOT COMPLETED |
|
|
| BG001 | Waitlist Control | Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Irritable Bowel Syndrome Quality of Life | Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome) | Mean | Standard Deviation | units on a scale |
|
| Gastrointestinal Symptom Rating Scale | Scale scores range from 0-78 with high scores representing worse GI symptoms. | Mean | Standard Deviation | units on a scale |
|
| GI Cognitions Questionnaire | Scale measures distorted, catastrophic beliefs about the social and occupational implications of having gastrointestinal symptoms. Scale scores range from 0 to 64 with higher scores representing worse outcomes (more distorted, catastrophic beliefs about GI symptoms) | Mean | Standard Deviation | units on a scale |
|
| Visceral Sensitivity Index | Scale measures anxiety about visceral (gut) sensations. Scale scores range from 0 to 75 with higher scores representing more anxiety. | Mean | Standard Deviation | units on a scale |
|
| Fear of Food Questionnaire | Scale measures fear of food and eating. Scale scores range from 0-90 with higher scores representing more fear and impairment. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire 9 | The PHQ measures the frequency of the 9 cardinal symptoms of depression. Scale score range from 0-27 with higher scores representing more severe/frequent depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Depression Anxiety and Stress Scale - Depression Subscale | The depression subscale of the Depression Anxiety and Stress Scale (DASS) ranges from 0-42 with higher scores representing worse depression. | Mean | Standard Deviation | units on a scale |
|
| Depression Anxiety and Stress Scale - Stress Subscale | The Stress subscale of DASS measures emotional reactivity to perceived stress. It ranges from 0-42 with higher scores reflecting more distress. | Mean | Standard Deviation | units on a scale |
|
| Depression Anxiety and Stress Scale - Anxiety Subscale | The Anxiety subscale of the DASS measures the affective and physical symptoms of anxiety. It ranges from 0-42 with higher scores representing worse anxiety. | Mean | Standard Deviation | units on a scale |
|
Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app.
|
|
| Primary | Gastrointestinal Symptom Rating Scale | a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Visceral Sensitivity Index | self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | GI Cognitions Questionnaire | self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Fear of Food Questionnaire | self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Patient Health Questionnaire | self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Depression Anxiety and Stress Scale - Depression Subscale | Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Depression Anxiety and Stress Scale - Stress Subscale | The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity. | Treatment completers and waitlist control participants at post-treatment. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | Depression Anxiety and Stress Scale - Anxiety Subscale | Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety. | Treatment completers and waitlist control participants at post-treatment | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Waitlist Control | Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app. | 0 | 59 | 0 | 59 | 0 | 59 |
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| D004066 | Digestive System Diseases |