Irritable Bowel Syndrome
Conditions
Keywords
cognitive behavioral therapy, self-help, irritable bowel syndrome
Brief summary
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.
Interventions
BEHAVIORALZemedy App for Irritable Bowel Syndrome
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.
Sponsors
Bold Health Inc.
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of IBS. Own a smart phone. Speak English
Exclusion criteria
* Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritable Bowel Syndrome Quality of Life | 8 weeks | 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. |
| Gastrointestinal Symptom Rating Scale | 8 weeks | a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear of Food Questionnaire | 8 weeks | self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome. |
| Patient Health Questionnaire | 8 weeks | self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome. |
| Visceral Sensitivity Index | 8 weeks | self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome. |
| Depression Anxiety and Stress Scale - Stress Subscale | 8 weeks | The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity. |
| Depression Anxiety and Stress Scale - Anxiety Subscale | 8 weeks | Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety. |
| Depression Anxiety and Stress Scale - Depression Subscale | 8 weeks | Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome. |
| GI Cognitions Questionnaire | 8 weeks | self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome. |
Countries
United States
Participant flow
Pre-assignment details
146 potential participants were consented and screened. 25 individuals met exclusion criteria (severe depression) and were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 62 |
| 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. | 59 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Randomization and Treatment | Lost to Follow-up | 26 | 15 |
| Screening | Physician Decision | 12 | 13 |
Baseline characteristics
| Characteristic | Immediate Treatment | Waitlist Control | Total |
|---|---|---|---|
| Age, Continuous | 33.21 years STANDARD_DEVIATION 10.1 | 30.71 years STANDARD_DEVIATION 10.2 | 32 years STANDARD_DEVIATION 10.2 |
| Depression Anxiety and Stress Scale - Anxiety Subscale | 12.03 units on a scale STANDARD_DEVIATION 7.35 | 13.19 units on a scale STANDARD_DEVIATION 9.14 | 12.6 units on a scale STANDARD_DEVIATION 8.25 |
| Depression Anxiety and Stress Scale - Depression Subscale | 11.65 units on a scale STANDARD_DEVIATION 9.88 | 15.59 units on a scale STANDARD_DEVIATION 10.69 | 13.57 units on a scale STANDARD_DEVIATION 10.43 |
| Depression Anxiety and Stress Scale - Stress Subscale | 17.84 units on a scale STANDARD_DEVIATION 9.56 | 18.71 units on a scale STANDARD_DEVIATION 8.97 | 18.26 units on a scale STANDARD_DEVIATION 9.25 |
| Fear of Food Questionnaire | 52.87 units on a scale STANDARD_DEVIATION 19.9 | 55.46 units on a scale STANDARD_DEVIATION 18.2 | 54.13 units on a scale STANDARD_DEVIATION 19.1 |
| Gastrointestinal Symptom Rating Scale | 36.76 units on a scale STANDARD_DEVIATION 12.77 | 37.75 units on a scale STANDARD_DEVIATION 12.02 | 37.42 units on a scale STANDARD_DEVIATION 12.4 |
| GI Cognitions Questionnaire | 36.76 units on a scale STANDARD_DEVIATION 12.77 | 37.75 units on a scale STANDARD_DEVIATION 12.02 | 37.24 units on a scale STANDARD_DEVIATION 12.4 |
| Irritable Bowel Syndrome Quality of Life | 53.63 units on a scale STANDARD_DEVIATION 18.67 | 60.48 units on a scale STANDARD_DEVIATION 18.29 | 56.97 units on a scale STANDARD_DEVIATION 18.7 |
| Patient Health Questionnaire 9 | 8.32 units on a scale STANDARD_DEVIATION 5.29 | 11.03 units on a scale STANDARD_DEVIATION 4.66 | 9.64 units on a scale STANDARD_DEVIATION 5.16 |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Multiple Race or Other | 8 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 50 Participants | 92 Participants |
| Region of Enrollment United States | 62 Participants | 59 Participants | 121 Participants |
| Sex: Female, Male Female | 49 Participants | 42 Participants | 91 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 30 Participants |
| Visceral Sensitivity Index | 51.74 units on a scale STANDARD_DEVIATION 12.29 | 53.54 units on a scale STANDARD_DEVIATION 11.44 | 52.62 units on a scale STANDARD_DEVIATION 11.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 59 |
| other Total, other adverse events | 0 / 62 | 0 / 59 |
| serious Total, serious adverse events | 0 / 62 | 0 / 59 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | Gastrointestinal Symptom Rating Scale | 27.56 score on a scale | Standard Deviation 10.12 |
| Waitlist Control | Gastrointestinal Symptom Rating Scale | 38.18 score on a scale | Standard Deviation 10.79 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | Irritable Bowel Syndrome Quality of Life | 34.25 score on a scale | Standard Deviation 19.78 |
| Waitlist Control | Irritable Bowel Syndrome Quality of Life | 58.19 score on a scale | Standard Deviation 18.53 |
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.
Time frame: 8 weeks
Population: Treatment completers and waitlist control participants at post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | Depression Anxiety and Stress Scale - Anxiety Subscale | 8.67 units on a scale | Standard Deviation 6.38 |
| Waitlist Control | Depression Anxiety and Stress Scale - Anxiety Subscale | 12.05 units on a scale | Standard Deviation 9.72 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | Depression Anxiety and Stress Scale - Depression Subscale | 7.83 score on a scale | Standard Deviation 7.88 |
| Waitlist Control | Depression Anxiety and Stress Scale - Depression Subscale | 15.45 score on a scale | Standard Deviation 10.39 |
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.
Time frame: 8 weeks
Population: Treatment completers and waitlist control participants at post-treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | Depression Anxiety and Stress Scale - Stress Subscale | 12.72 units on a scale | Standard Deviation 8.65 |
| Waitlist Control | Depression Anxiety and Stress Scale - Stress Subscale | 18.82 units on a scale | Standard Deviation 9.99 |
Secondary
Fear of Food Questionnaire
self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | Fear of Food Questionnaire | 41.22 score on a scale | Standard Deviation 22.23 |
| Waitlist Control | Fear of Food Questionnaire | 53.75 score on a scale | Standard Deviation 18.08 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | GI Cognitions Questionnaire | 22.44 score on a scale | Standard Deviation 13.72 |
| Waitlist Control | GI Cognitions Questionnaire | 40.84 score on a scale | Standard Deviation 11.23 |
Secondary
Patient Health Questionnaire
self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | Patient Health Questionnaire | 5.78 score on a scale | Standard Deviation 4.2 |
| Waitlist Control | Patient Health Questionnaire | 10.32 score on a scale | Standard Deviation 4.29 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment | Visceral Sensitivity Index | 38.14 score on a scale | Standard Deviation 16.21 |
| Waitlist Control | Visceral Sensitivity Index | 53.57 score on a scale | Standard Deviation 12.37 |