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Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04170686
Recruitment Status : Completed
First Posted : November 20, 2019
Results First Posted : December 24, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
Bold Health Inc.
Information provided by (Responsible Party):
Melissa Hunt, PhD, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome
Intervention Behavioral: Zemedy App for Irritable Bowel Syndrome
Enrollment 146
Recruitment Details  
Pre-assignment Details 146 potential participants were consented and screened. 25 individuals met exclusion criteria (severe depression) and were not randomized.
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description

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.

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.
Period Title: Screening
Started 74 72
Completed 62 59
Not Completed 12 13
Reason Not Completed
Physician Decision             12             13
Period Title: Randomization and Treatment
Started 62 59
Completed 36 44
Not Completed 26 15
Reason Not Completed
Lost to Follow-up             26             15
Arm/Group Title Immediate Treatment Waitlist Control Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 62 59 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 59 participants 121 participants
33.21  (10.1) 30.71  (10.2) 32  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
Female
49
  79.0%
42
  71.2%
91
  75.2%
Male
13
  21.0%
17
  28.8%
30
  24.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
Asian
4
   6.5%
1
   1.7%
5
   4.1%
Black or African American
4
   6.5%
2
   3.4%
6
   5.0%
White
42
  67.7%
50
  84.7%
92
  76.0%
Multiple Race or Other
8
  12.9%
3
   5.1%
11
   9.1%
Hispanic
4
   6.5%
3
   5.1%
7
   5.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 62 participants 59 participants 121 participants
62
 100.0%
59
 100.0%
121
 100.0%
Irritable Bowel Syndrome Quality of Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
53.63  (18.67) 60.48  (18.29) 56.97  (18.7)
[1]
Measure Description: Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome)
Gastrointestinal Symptom Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
36.76  (12.77) 37.75  (12.02) 37.42  (12.4)
[1]
Measure Description: Scale scores range from 0-78 with high scores representing worse GI symptoms.
GI Cognitions Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
36.76  (12.77) 37.75  (12.02) 37.24  (12.4)
[1]
Measure Description: 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)
Visceral Sensitivity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
51.74  (12.29) 53.54  (11.44) 52.62  (11.9)
[1]
Measure Description: Scale measures anxiety about visceral (gut) sensations. Scale scores range from 0 to 75 with higher scores representing more anxiety.
Fear of Food Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
52.87  (19.9) 55.46  (18.2) 54.13  (19.1)
[1]
Measure Description: Scale measures fear of food and eating. Scale scores range from 0-90 with higher scores representing more fear and impairment.
Patient Health Questionnaire 9   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
8.32  (5.29) 11.03  (4.66) 9.64  (5.16)
[1]
Measure Description: 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.
Depression Anxiety and Stress Scale - Depression Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
11.65  (9.88) 15.59  (10.69) 13.57  (10.43)
[1]
Measure Description: The depression subscale of the Depression Anxiety and Stress Scale (DASS) ranges from 0-42 with higher scores representing worse depression.
Depression Anxiety and Stress Scale - Stress Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
17.84  (9.56) 18.71  (8.97) 18.26  (9.25)
[1]
Measure Description: The Stress subscale of DASS measures emotional reactivity to perceived stress. It ranges from 0-42 with higher scores reflecting more distress.
Depression Anxiety and Stress Scale - Anxiety Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 59 participants 121 participants
12.03  (7.35) 13.19  (9.14) 12.6  (8.25)
[1]
Measure Description: 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.
1.Primary Outcome
Title Irritable Bowel Syndrome Quality of Life
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: score on a scale
34.25  (19.78) 58.19  (18.53)
2.Primary Outcome
Title Gastrointestinal Symptom Rating Scale
Hide Description a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: score on a scale
27.56  (10.12) 38.18  (10.79)
3.Secondary Outcome
Title Visceral Sensitivity Index
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: score on a scale
38.14  (16.21) 53.57  (12.37)
4.Secondary Outcome
Title GI Cognitions Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: score on a scale
22.44  (13.72) 40.84  (11.23)
5.Secondary Outcome
Title Fear of Food Questionnaire
Hide Description self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: score on a scale
41.22  (22.23) 53.75  (18.08)
6.Secondary Outcome
Title Patient Health Questionnaire
Hide Description self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.78  (4.2) 10.32  (4.29)
7.Secondary Outcome
Title Depression Anxiety and Stress Scale - Depression Subscale
Hide Description Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.83  (7.88) 15.45  (10.39)
8.Secondary Outcome
Title Depression Anxiety and Stress Scale - Stress Subscale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment completers and waitlist control participants at post-treatment.
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.72  (8.65) 18.82  (9.99)
9.Secondary Outcome
Title Depression Anxiety and Stress Scale - Anxiety Subscale
Hide Description Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment completers and waitlist control participants at post-treatment
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 36 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.67  (6.38) 12.05  (9.72)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Treatment Waitlist Control
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Immediate Treatment Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/59 (0.00%) 
Hide Serious Adverse Events
Immediate Treatment Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/59 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immediate Treatment Waitlist Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/59 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Melissa G. Hunt
Organization: University of Pennsylvania
Phone: 610-529-8055
EMail: mhunt@psych.upenn.edu
Layout table for additonal information
Responsible Party: Melissa Hunt, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04170686    
Other Study ID Numbers: 833848
First Submitted: November 14, 2019
First Posted: November 20, 2019
Results First Submitted: October 26, 2020
Results First Posted: December 24, 2020
Last Update Posted: February 16, 2021