Trial Outcomes & Findings for Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome (NCT NCT04170686)
NCT ID: NCT04170686
Last Updated: 2021-02-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-02-16
Participant Flow
146 potential participants were consented and screened. 25 individuals met exclusion criteria (severe depression) and were not randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Screening
STARTED
|
74
|
72
|
|
Screening
COMPLETED
|
62
|
59
|
|
Screening
NOT COMPLETED
|
12
|
13
|
|
Randomization and Treatment
STARTED
|
62
|
59
|
|
Randomization and Treatment
COMPLETED
|
36
|
44
|
|
Randomization and Treatment
NOT COMPLETED
|
26
|
15
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Screening
Physician Decision
|
12
|
13
|
|
Randomization and Treatment
Lost to Follow-up
|
26
|
15
|
Baseline Characteristics
Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
Baseline characteristics by cohort
| Measure |
Immediate Treatment
n=62 Participants
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.
|
Waitlist Control
n=59 Participants
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.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.21 years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
30.71 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
32 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple Race or Other
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Irritable Bowel Syndrome Quality of Life
|
53.63 units on a scale
STANDARD_DEVIATION 18.67 • n=99 Participants
|
60.48 units on a scale
STANDARD_DEVIATION 18.29 • n=107 Participants
|
56.97 units on a scale
STANDARD_DEVIATION 18.7 • n=206 Participants
|
|
Gastrointestinal Symptom Rating Scale
|
36.76 units on a scale
STANDARD_DEVIATION 12.77 • n=99 Participants
|
37.75 units on a scale
STANDARD_DEVIATION 12.02 • n=107 Participants
|
37.42 units on a scale
STANDARD_DEVIATION 12.4 • n=206 Participants
|
|
GI Cognitions Questionnaire
|
36.76 units on a scale
STANDARD_DEVIATION 12.77 • n=99 Participants
|
37.75 units on a scale
STANDARD_DEVIATION 12.02 • n=107 Participants
|
37.24 units on a scale
STANDARD_DEVIATION 12.4 • n=206 Participants
|
|
Visceral Sensitivity Index
|
51.74 units on a scale
STANDARD_DEVIATION 12.29 • n=99 Participants
|
53.54 units on a scale
STANDARD_DEVIATION 11.44 • n=107 Participants
|
52.62 units on a scale
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Fear of Food Questionnaire
|
52.87 units on a scale
STANDARD_DEVIATION 19.9 • n=99 Participants
|
55.46 units on a scale
STANDARD_DEVIATION 18.2 • n=107 Participants
|
54.13 units on a scale
STANDARD_DEVIATION 19.1 • n=206 Participants
|
|
Patient Health Questionnaire 9
|
8.32 units on a scale
STANDARD_DEVIATION 5.29 • n=99 Participants
|
11.03 units on a scale
STANDARD_DEVIATION 4.66 • n=107 Participants
|
9.64 units on a scale
STANDARD_DEVIATION 5.16 • n=206 Participants
|
|
Depression Anxiety and Stress Scale - Depression Subscale
|
11.65 units on a scale
STANDARD_DEVIATION 9.88 • n=99 Participants
|
15.59 units on a scale
STANDARD_DEVIATION 10.69 • n=107 Participants
|
13.57 units on a scale
STANDARD_DEVIATION 10.43 • n=206 Participants
|
|
Depression Anxiety and Stress Scale - Stress Subscale
|
17.84 units on a scale
STANDARD_DEVIATION 9.56 • n=99 Participants
|
18.71 units on a scale
STANDARD_DEVIATION 8.97 • n=107 Participants
|
18.26 units on a scale
STANDARD_DEVIATION 9.25 • n=206 Participants
|
|
Depression Anxiety and Stress Scale - Anxiety Subscale
|
12.03 units on a scale
STANDARD_DEVIATION 7.35 • n=99 Participants
|
13.19 units on a scale
STANDARD_DEVIATION 9.14 • n=107 Participants
|
12.6 units on a scale
STANDARD_DEVIATION 8.25 • n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksA 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.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
Irritable Bowel Syndrome Quality of Life
|
34.25 score on a scale
Standard Deviation 19.78
|
58.19 score on a scale
Standard Deviation 18.53
|
PRIMARY outcome
Timeframe: 8 weeksa self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
Gastrointestinal Symptom Rating Scale
|
27.56 score on a scale
Standard Deviation 10.12
|
38.18 score on a scale
Standard Deviation 10.79
|
SECONDARY outcome
Timeframe: 8 weeksself-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
Visceral Sensitivity Index
|
38.14 score on a scale
Standard Deviation 16.21
|
53.57 score on a scale
Standard Deviation 12.37
|
SECONDARY outcome
Timeframe: 8 weeksself-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
GI Cognitions Questionnaire
|
22.44 score on a scale
Standard Deviation 13.72
|
40.84 score on a scale
Standard Deviation 11.23
|
SECONDARY outcome
Timeframe: 8 weeksself-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
Fear of Food Questionnaire
|
41.22 score on a scale
Standard Deviation 22.23
|
53.75 score on a scale
Standard Deviation 18.08
|
SECONDARY outcome
Timeframe: 8 weeksself-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
Patient Health Questionnaire
|
5.78 score on a scale
Standard Deviation 4.2
|
10.32 score on a scale
Standard Deviation 4.29
|
SECONDARY outcome
Timeframe: 8 weeksSelf-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
Depression Anxiety and Stress Scale - Depression Subscale
|
7.83 score on a scale
Standard Deviation 7.88
|
15.45 score on a scale
Standard Deviation 10.39
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Treatment completers and waitlist control participants at post-treatment.
The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
Depression Anxiety and Stress Scale - Stress Subscale
|
12.72 units on a scale
Standard Deviation 8.65
|
18.82 units on a scale
Standard Deviation 9.99
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Treatment completers and waitlist control participants at post-treatment
Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.
Outcome measures
| Measure |
Immediate Treatment
n=36 Participants
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.
|
Waitlist Control
n=44 Participants
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.
|
|---|---|---|
|
Depression Anxiety and Stress Scale - Anxiety Subscale
|
8.67 units on a scale
Standard Deviation 6.38
|
12.05 units on a scale
Standard Deviation 9.72
|
Adverse Events
Immediate Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place