Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS
Phase: NA
Conditions: Irritable Bowel Syndrome
Sponsor: University of Pennsylvania

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Cover Page: 
 
NCT#:   NCT04665271 
 
Title:  Acceptability and Efficacy of Zemedy App versus an Education and 
Relaxation Training App for IBS 
 
Date January 14, 2021 
 
 

Page 2 of 16 
 
Modification 
Basic Info 
Confirmation Number: 
ddaedhbe 
Protocol Number: 
844160 
Created By: 
HUNT, MELISSA G 
Principal Investigator: 
HUNT, MELISSA G 
Protocol Title: 
Acceptability and Efficacy of Zemedy App versus an Education and Relaxation Training App for IBS 
Short Title: 
Zemedy App 2.0 
Protocol Description: 
The purpose of this research is to assess if a new phone app version of a self-help intervention for 
Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall 
quality of life in patients with IBS. 
Submission Type: 
Social and Biological Sciences 
Application Type: 
EXPEDITED Category 7 
PennERA Protocol Status 
Approved (No CR) 
Resubmission* 
No 
Are you submitting a Modification to this protocol?* 
Yes 
Current Status of Study 
Study Status 
Study has not begun (no subjects entered) 
If study is currently in progress, please enter the following 
Number of subjects enrolled at Penn since the study was initiated 
0 
Actual enrollment at participating centers 
0 
If study is closed to further enrollment, please enter the following 
Number of subjects in therapy or intervention 

Page 3 of 16 
0 
Number of subjects in long-term follow-up only 
0 
IRB Determination 
If the change represents more than minimal risk to subjects, it must be reviewed and approved by the IRB 
at a convened meeting. For a modification to be considered more than minimal risk, the proposed change 
would increase the risk of discomfort or decrease benefit. The IRB must review and approve the proposed 
change at a convened meeting before the change can be implemented unless the change is necessary to 
eliminate an immediate hazard to the research participants. In the case of a change implemented to 
eliminate an immediate hazard to participants, the IRB will review the change to determine that it is 
consistent with ensuring the participant&prime;s continued welfare. Examples: Convened Board Increase 
in target enrollment for investigator initiated research or potential Phase I research Expanding inclusion or 
removing exclusion criteria where the new population may be at increased risk Revised risk information 
with active participants Minor risk revisions that may affect a subject&prime;s willingness to continue to 
participate Expedited Review Increase in target enrollment at Penn where overall enrollment target is not 
exceeded or potentially sponsored research Expanding inclusion or removing exclusion where the new 
population has the same expected risk as the previous, based on similarities of condition Revised risk 
information with subjects in long-term follow-up Minor risk revisions with no subjects enrolled to date 
Expedited Review 
Modification Summary 
Please describe any required modification to the protocol. If you are using this form to submit an exception 
or report a deviation, enter 'N/A' in the box below. 
We have changed the nature of the active control condition. Rather than using an established mindfulness 
meditation app we are using a control app that includes links to NICE IBS treatment guidelines and 
multiple relaxation training videos. 
Risk / Benefit 
Does this amendment alter the Risk/Benefit profile of the study? 
No 
Change in Consent 
Has there been a change in the consent documents? 
Yes 
If YES, please choose from the options below regarding re-consenting 
Our site does not plan to obtain re-consent 
Deviations 
Are you reporting a deviation to this protocol?* 
No 
Exceptions 
Are you reporting an exception to this protocol?* 
No 

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Protocol Details 
Resubmission* 
Yes 
Hospital Sites 
Will any research activities and/or services be conducted at a Penn Medicine affiliated hospital site? 
No 
Study Personnel 
Principal Investigator 
Name: 
HUNT, MELISSA G 
Dept / School / Div: 
120 - Psychology 
Campus Address 
Mail Code 
6241 
Address: 
PSYCHOLOGY  
3720 WALNUT STREET  
City State Zip: 
PHILADELPHIA PA 19104-6241 
Phone: 
215-898-6103 
Fax: 
- 
Pager: 
Email: 
mhunt@psych.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
10/04/2020 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 
Study Contacts 
None 
Other Investigator 
None 
Responsible Org (Department/School/Division): 
120 - Psychology 
Key Study Personnel 
Name: 
IPEK, SIMAY I 
Department/School/Division: 
The College 
HS Training Completed: 
Yes 

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Training Expiration Date: 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
MIGUEZ, SOFIA M 
Department/School/Division: 
The College 
HS Training Completed: 
Yes 
Training Expiration Date: 
09/02/2022 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
DALVIE, ANIKA S 
Department/School/Division: 
The College 
HS Training Completed: 
Yes 
Training Expiration Date: 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
WASMAN, BENJAMIN A 
Department/School/Division: 
The College 
HS Training Completed: 
Yes 
Training Expiration Date: 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Disclosure of Significant Financial Interests* 
Does any person who is responsible for the design, conduct, or reporting of this research protocol have a 
FINANCIAL INTEREST? No 
Penn Intellectual Property* 
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, development 
or evaluation of a drug, device, product, or other type of intellectual property (IP) that is owned by or 
assigned to the University of Pennsylvania? 
No 
Certification 
I have reviewed the Financial Disclosure and Presumptively Prohibited Conflicts for Faculty Participating 
in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored Projects  with all 
persons who are responsible for the design, conduct, or reporting of this research; and all required 
Disclosures have been attached to this application. 
Yes 
Social and Biological Sciences 
Study Instruments 
Discuss the particulars of the research instruments, questionnaires and other evaluation instruments in 
detail. Provide validation documentation and or procedures to be used to validate instruments. For well 
know and generally accepted test instruments the detail here can be brief. More detail may be required for 
a novel or new instrument. For ethnographic studies identify any study instruments to be used (i.e. for 
deception studies) and describe in detail where, when and how the study will be conducted and who or 
what are the subjects of study. Note: For more information on how to conduct ethical and valid 
ethnographic research, follow the link For oral histories or interviews provide the general framework for 

Page 6 of 16 
questioning and means of data collection. If interviews or groups settings are to be audio taped or video 
taped describe in detail the conditions under which it will take place. Include a copy of any novel or new 
test instruments with the IRB submission.  
Symptom Questionnaire of Rome IV Diagnostic Criteria for IBS. (Whitehead, et al.2016. Rome IV  
Diagnostic Questionnaires. The Rome Foundation.) Gastrointestinal Symptom Rating Scale (GSRS) 
(Wiklund, I. K., Fullerton, S., Hawkey, C. J., Jones, R. H., Longstreth, G. F., Mayer, E. A., . . . Naesdal, J. 
(2003). An irritable bowel syndrome-specific symptom questionnaire: Development and validation. 
Scandinavian Journal of Gastroenterology, 38(9), 947-95.) 13 items covering symptom severity in IBS. 
IBS Quality of Life (IBSQoL) (Patrick, D. L., Drossman, D. A., Frederick, I. O., DiCesare, J., & Puder, 
K. L. (1998). Quality of  life in persons with irritable bowel syndrome: Development and validation of a 
new measure. Digestive Diseases and Sciences, 43(2), 400-411.) The standard measure of health related 
quality of life for people with IBS. Visceral Sensitivity Index (VSI - Aliment Pharmacol Ther. 2004 Jul 
1;20(1):89-97. The Visceral Sensitivity Index: development and validation of a gastrointestinal symptom-
specific anxiety scale. Labus JS, Bolus R, Chang L, Wiklund I, Naesdal J, Mayer EA, Naliboff BD.) - The 
Visceral Sensitivity Index (VSI) is a widely used a unidimensional 15-item scale that measures 
gastrointestinal symptom-specific anxiety (GSA). Preliminary and follow-up studies have found high 
internal consistency for the VSI, reporting a Cronbachs of about 0.93 and a mean inter-item correlation of 
0.47 (26, 27). Criterion and construct validity tests showed the VSI, when compared to the ASI and the 
HAD, to be the strongest predictor of current IBS symptom severity (26). Studies have also shown the VSI 
to have good concurrent, divergent and discriminant validity (27).  Gastrointestinal Cognitions 
Questionnaire (Hunt, M., Ertel, E., Coello, J. & Rodriguez, L. (2014). Development and validation of the 
GI-Cognitions Questionnaire. Cognitive Therapy and Research, 38(4), 472-482.) - The GI-Cog consists of 
18 self-report items that are rated on a 5-point Likert scale, ranging from 0 (Hardly) to 4 (Very much). The 
questionnaire consists of three subscales. The pain/life interference subscale (e.g., When I feel my GI 
symptoms acting up, I'm afraid the pain will be excruciating and intolerable), the social anxiety subscale 
(e.g., If I have to get up and leave an event, meeting, or social gathering to go to the bathroom people will 
think theres something wrong with me), and the disgusts sensitivity subscale (e.g., The thought of fecal 
incontinence is terrifying. If it happened, it would be awful). The GI-Cog has been shown to have excellent 
internal consistency ( = .92) and test re-test reliability (r = .87, p .001) (Hunt, Ertel, Rodriguez et al., 2012).  
Fear of Food Questionnare (FFQ) (Hunt, M., Zickgraf, H., Gibbons, B. & Loftus, P. (2018). Development 
and Validation of the  Fear of Food Questionnaire (FFQ). Poster presented at the annual meeting of the 
Anxiety and Depression Association of America. Washington, DC.) A brief self-report instrument 
assessing fear of food and loss of pleasure in eating. Beck Depression Inventory-II (Beck, A. T., Steer, R. 
A., & Brown, G. (1996). Beck Depression InventoryII. APA PsycTests.)  Mobile Application Rating Scale 
user version (uMARS) (Stoyanov, S. R., Hides, L., Kavanagh, D. J., & Wilson, H. (2016). Development 
and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR mHealth and 
uHealth, 4(2), e72.).  Work productivity and activity impairment questionnaire- irritable bowel syndrome 
version (WPAI:IBS) (Reilly, M.C., Bracco, A., Ricci, J.F., Santoro, J. and Stevens, T. (2004), The validity 
and accuracy of the Work Productivity and Activity Impairment questionnaire irritable bowel syndrome 
version (WPAI:IBS). Alimentary Pharmacology & Therapeutics, 20: 459-467.)  The Work and Social 
Adjustment Scale (WSAS) (Mundt JC, Marks IM, Shear MK, Greist JH.) A simple measure of impairment 
in functioning. Br J Psychiatry. 2002 May;180:461-4.  Demographic survey- Participants will be asked to 
complete a survey of demographic information, that will help to determine whether the sample is 
representative and detect any underlying differences between the wait-list group and the intervention 
group. It will also aid the investigators in examining whether the effects of the intervention differ according 
to demographic characteristics. All questionnaires are standardized questionnaires in the literature that are 
readily available for use. 
Group Modifications 
Describe necessary changes that will or have been made to the study instruments for different groups. 
NA 
Method for Assigning Subjects to Groups 
Describe how subjects will be randomized to groups. 
Participants will be randomly assigned to either the immediate treatment group or an active control group. 
Random assignment will be determined using the random.org coin toss. 

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Administration of Surveys and/or Process 
Describe the approximate time and frequency for administering surveys and/or evaluations. For surveys, 
questionnaires and evaluations presented to groups and in settings such as high schools, focus group 
sessions or community treatment centers explain how the process will be administered and who will 
oversee the process. For instance, discuss the potential issues of having teachers and other school personnel 
administer instruments to minors who are students especially if the content is sensitive in nature. Describe 
the procedure for audio and videotaping individual interviews and/or focus groups and the storage of the 
tapes. For instance, if audio tape recording is to be used in a classroom setting, describe how this will be 
managed if individuals in the class are not participating in the study. Explain if the research involves the 
review of records (including public databases or registries) with identifiable private information. If so, 
describe the type of information gathered from the records and if identifiers will be collected and retained 
with the data after it is retrieved. Describe the kinds of identifiers to be obtained, (i.e. names, social security 
numbers) and how long the identifiers will be retained and justification for use.  
Recruitment: We will recruit study participants via online communities focused on IBS, including Reddit, 
Healing Well, Facebook and so on. Interested individuals will be able to click a link to the Qualtrics 
platform where they will first see the Explanation of Research and then will be invited to complete all the 
baseline measures. When they have completed the consent and initial screening questionnaires, eligible 
participants will be randomized as above and either given access to either the Zemedy the app or a control 
mindfulness meditation app.  At 8 weeks after enrollment, all participants in both the control group and 
self-help app group will receive a battery of follow-up questionnaires (the same that they answered directly 
after consenting in the beginning of the study as baseline measures). After completing the 8 week 
questionnaires, participants in the control group will be offered access to the Zemedy app. All participants 
will receive 3 month post-treatment follow-up questionnaires.  All questionnaires will be available through 
qualtrics.com. Study investigators will be responsible for sending participants the e-mails, the links to the 
follow up questionnaires, monitoring the questionnaires online, and answering any questions participants 
may have through e-mail. Questionnaires may take approximately 30-45 minutes to complete. 
Data Management 
Describe how and who manages confidential data, including how and where it will be stored and analyzed. 
For instance, describe if paper or electronic report forms will be used, how corrections to the report form 
will be made, how data will be entered into any database, and the person(s) responsible for creating and 
maintaining the research database. Describe the use of pseudonyms, code numbers and how listing of such 
identifiers will be kept separate from the research data.  
Data from completed study questionnaires and other materials will be collected via Qualtrics secure 
servers. This account is password protected and only study investigators will have access to the 
questionnaire data. E-mails to participants will be sent from the PI's university email account. Participant 
identification and contact information will be stored electronically in a single spreadsheet which only study 
investigators will have access to. The spreadsheet will be saved on a passwordprotected computer in the 
PIs lab. A master database of questionnaire responses, containing no identifying participant information, 
will be created and maintained by the PI. This database will only reside on the PI's password protected 
Penn computer. All data analysis will take place either on the PIs office PC, or in the PIs lab. 
Radiation Exposure* 
Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, 
FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol? 
No 
Human Source Material* 
Does this research include collection or use of human source material (i.e., human blood, blood products, 
tissues or body fluids)? 
No 
CACTIS and CT Studies* 
Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS) and 
CT studies that research subjects would not receive if they were not part of this protocol? 
No 

Page 8 of 16 
CAMRIS and MRI Studies* 
Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy 
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this protocol? 
No 
Cancer Related research not being conducted by an NCI cooperative group* 
Does this protocol involve cancer-related studies in any of the following categories? 
No 
Medical Information Disclosure* 
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes? 
No 
CTRC Resources* 
Does the research involve CTRC resources? 
No 
If the answer is YES, indicate which items is is provided with this submission: 
Use of UPHS services* 
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes? 
No 
Primary Focus* 
Sociobehavioral (i.e. observational or interventional) 
Protocol Interventions 
x Sociobehavioral (i.e. cognitive or behavioral therapy) 
Drug 
Device - therapeutic 
Device - diagnostic (assessing a device for sensitivity or specificity in disease diagnosis) 
Surgical 
Diagnostic test/procedure (research-related diagnostic test or procedure) 
Obtaining human tissue for basic research or biospecimen bank 
Survey instrument None of the above 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
Department budget code 
None 
Multi-Center Research 
Penn as lead 
1. Is this a multi-center study where Penn is serving as the Lead Site or the Penn PI is serving as the Lead 
Investigator? 
No 
Management of Information for Multi-Center Research 

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Penn irb of record 
2. Is this a multi-center study where the Penn IRB will be asked to serve as the IRB of Record for other 
external study sites? 
No 
Other Sites 
No other sites 
Protocol 
Abstract 
The purpose of this research is to assess if an updated version of a self-help app for IBS is an acceptable 
and effective intervention for improving the overall quality of life in patients with Irritable Bowel 
Syndrome. 
Objectives 
Overall objectives 
As self-help modalities are increasingly available online and through smart phone apps, it is increasingly 
important to test the acceptability and efficacy of those apps through rigorous, controlled research. Bold 
Health (https://www.bold.health/) is a company in the UK committed to developing effective digital health 
interventions for a number of hard to treat conditions, including IBS. They have agreed to partner with me 
to make their app available for free to research participants so that we can test its acceptability and efficacy. 
Primary outcome variable(s) 
GSRS IBSQoL ROME IV Symptoms and IBS Diagnosis GI symptom severity and overall health related 
quality of life are the primary outcome measures. 
Secondary outcome variable(s) 
VSI GICoG FFQ  BDI WPAI WSAS 
Background 
Irritable Bowel Syndrome is a functional GI disorder that responds poorly to traditional medical 
management. Various psychosocial, mind/body treatments have been shown to be quite efficacious when 
delivered in person, in group format, via the internet with limited therapist feedback and in selfhelp book 
format. These interventions include cognitive-behavioral therapy, gut directed hypnotherapy, mindfulness 
and acceptance based interventions and interoceptive exposure therapy. With the population increasingly 
interested in digital, interactive interventions, the time is ripe to develop and test a digital app that can be 
downloaded to smart phones. Bold Health has developed such an app that combines the best of many 
treatment modalities. (For example, Dr. Peter Whorwell, the developer of gut directed hypnotherapy, wrote 
and recorded all the hypnotherapy imagery scripts for them.) They are interested in subjecting their app to 
rigorous testing to determine its acceptability and efficacy. an initial RCT of version 1.0 of the app was 
extremely promising. This is an RCT of an improved version 2.0 of the same app. They have agreed to 
make the app available at no cost to research participants in this trial. 
Study Design 
Phase* 
Not applicable 
Design 
The aim of the current study is to test the acceptability and efficacy of an updated digital app for IBS 
patients. The design of the study is experimental. There will be two experimental groups, an immediate 

Page 10 of 16 
treatment group and an active control group. Once consented and enrolled, participants will be randomly 
assigned to either the immediate treatment group or the active control group by the coin toss feature of 
random.org. Participants in the immediate treatment group will be able to download the app at no cost. 
Participants in the control group will be given access to a educational and relaxation training app at no cost 
to them. At 8 weeks after enrollment, all participants in both groups will receive a battery of follow-up 
questionnaires (the same that they answered directly after consenting in the beginning of the study as 
baseline measures). Upon receipt of the 8 week questionnaire data, participants in the control group will 
be given access to the Zemedy app. After having had access to the app for 8 weeks, control participants 
will be asked to complete another set of questionnaires. All participants will receive 3 month post-treatment 
follow-up questionnaires. The research method is experimental (randomized controlled trial) with a control 
control. Participation in the study will last approximately 4.5 months, depending on the subjects 
willingness to participate and rate of completion. All contact with participants will be over the Internet via 
e-mail and electronic questionnaires through Qualtrics. All study questionnaires and use of the app will be 
completed at the subjects' convenience and in their own home. All electronic questionnaire responses will 
be gathered via Qualtrics secure servers. Questionnaire responses will be de-identified from participants' 
contact information and will be assigned a code number in the main data file. Responses will be 
incorporated into a master database for further analysis. The master database will be password protected 
and only study investigators and the study PI will have access to the file. 
Study duration 
The study will take place over approximately 18 months, from initial approval in November 2020 to the 
final round of follow-up data collection in the spring of 2022. Each participant will be involved in the 
study for a total of 5 months (if assigned to the immediate treatment group) or 7 months if assigned to the 
active control group. Individuals in the immediate treatment group will be assessed at baseline, again at 8 
weeks (immediately post-treatment) and again 3 months later (total 5 months). Individuals in the active 
control group will be assessed at baseline, again at 8 weeks at which point they will be offered cross-over 
to the Zemedy app and will be assessed again at 8 weeks post-treatment, and one final time 3 months later 
(total 7 months). 
Resources necessary for human research protection 
Describe research staff and justify that the staff are adequate in number and qualifications to conduct the 
research. Describe how you will ensure that all staff assisting with the research are adequately informed 
about the protocol and their research related duties. Please allow adequate time for the researchers to 
conduct and complete the research. Please confirm that there are adequate facilities for the research. 
The PI, Dr. Melissa Hunt, is a licensed clinical psychologist who has conducted a number of such trials in 
the domain of chronic GI disorders. 
Characteristics of the Study Population 
Target population 
The target population is individuals who have been diagnosed with IBS. 
Subjects enrolled by Penn Researchers 
300 
Subjects enrolled by Collaborating Researchers 
0 
Accrual 
Participants will consist of individuals currently suffering from IBS. There are many online forums that  
IBS patients frequent searching for advice, management strategies and support, including Reddit, 
Facebook, Healing Well and others. Participating in those forums allows researchers to recruit participants 
to trials like this one. Online trials like this typically have attrition rates of about 50% from the intent to 
treat sample. An initial enrollment of 300 would end with approximately 150 treatment completers, or 75 
per group. Because we are using an active control that we expect to benefit participants to some extent, we 

Page 11 of 16 
expect to find small to medium effect sizes in our between group differences. Given such moderate effect 
sizes, an N of 75 per group should allow us to detect significant effects at the level of alpha .05. 
Key inclusion criteria 
In order to be included in the study, subject must be at least 18 years of age or older, speak English, and 
have been previously diagnosed with IBS. Subjects must also own a smart phone and be willing to 
download either app. 
Key exclusion criteria 
Subjects will be excluded from the study if they are under 18 years of age, and therefore under the age of 
consent. However, subjects will not be excluded based on age if over 18 years old. Subjects will be 
excluded if they have another gastro-intestinal disorder (such as an inflammatory bowel disease.) Subjects 
will not be excluded based on sex, race, socioeconomic status, or religion. Participants reporting severe 
levels of depression, or active suicidal ideation with intent will not be included in the trial, but will be 
offered the Zemedy app at no cost. 
Vulnerable Populations 
Children Form 
Pregnant women (if the study procedures may affect the condition of the pregnant woman or fetus) 
Form 
Fetuses and/or Neonates Form 
Prisoners Form 
Other x None of the above populations are included in the 
research study 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
Populations vulnerable to undue influence or coercion 
NA 
Subject recruitment 
We will recruit study participants via various online support groups and message boards. The invitational 
post will include a link to the study Qualtrics page which will start with the Statement of Research/Consent 
and then proceed to the baseline questionnaires. We will also use graphic ads on Facebook that provide 
the same link to the study. Upon receipt of the questionnaires and determination of eligibility, the 
participants will be randomized and contacted with their group assignment. 
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does the 
study team plan to directly use social media to recruit for the research? 
No 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
Subject compensation* 
Will subjects be financially compensated for their participation? 
Yes 
The following documents are currently attached to this item: 
There are no documents attached for this item. 

Page 12 of 16 
If there is subject compensation, provide the schedule for compensation per study visit or session and 
total amount for entire participation, either as text or separate document 
If subjects are in the immediate treatment group, they will be compensated $20 for completing the 
posttreatment follow-up questionnaires in the week or so after they complete the program. They will be 
compensated a further $20 for completing the follow-up questionnaires 3 months after completing the 
program. Thus, their total compensation could be as much as $40.  If they are in the control group, they 
will be compensated $20 for completing the follow-up questionnaires 8 weeks after the initial 
questionnaires. They will be compensated a further $20 for completing another set of follow-up 
questionnaires in the week or so after they complete the program. Finally, they will be compensated a 
further $20 for completing the follow-up questionnaires 3 months after completing the program. Thus, 
their total compensation could be as much as $60. People who are randomly assigned to the control group 
will be compensated more money to help make up for the fact that they had to wait for two months to 
access the app, and have to fill out the questionnaires one extra time. 
Study Procedures 
Suicidal Ideation and Behavior 
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)? 
No 
Procedures 
We will recruit study participants via online support groups, and online message boards. Interested parties 
will click on a link to the study Qualtrics page, which will start with the consent form/statement of research 
and then ask subjects to complete all the baseline questionnaires, including the Rome IV, GSRS, IBSQoL, 
VSI, GICoG, FFQ, uMARS, WPAI, WSAS and BDI-II. Upon receipt of the questionnaires and 
determination of eligibility, the participants will be randomized and contacted via email with their group 
assignment. Subjects will be given information about how to download either the standard mindfulness 
app or the Zemedy app at no cost to them. The only contact information required will be the subject's e-
mail address to identify their responses. All forms of contact will be via email, as we do not have any 
intention of contacting participants via phone. At 4 weeks after enrollment, both groups will be provided 
with a check-in email to reassure them that any logistical questions can be answered by the investigators 
at any point in the study and to encourage them to continue using the app. At 8 weeks after enrollment, all 
participants in both groups will receive a battery of follow-up questionnaires (the same that they answered 
directly after consenting in the beginning of the study as baseline measures). Upon receipt of the 8 week 
data, the individuals in the control group will be given access to the Zemedy app at no cost. All groups 
will receive 3 month post-treatment follow-up questionnaires. All questionnaires will be available through 
qualtrics.com. Study investigators will be responsible for sending participants the emails, the follow up 
questionnaires, monitoring the questionnaires online, and answering any questions participants may have 
through email. Questionnaires may take approximately 30-45 minutes to complete. 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
Deception 
Does your project use deception? 
No 
International Research 
Are you conducting research outside of the United States? 
No 
Analysis Plan 
Data will be analyzed using standard parametric procedures, including t-test, repeated measures ANOVA 
and simultaneous multiple regression. 

Page 13 of 16 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
Data confidentiality 
Paper-based records will be kept in a secure location and only be accessible to personnel involved in 
the study. 
x Computer-based files will only be made available to personnel involved in the study through the 
use of access privileges and passwords. 
Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and confidentiality of identifiable information. 
x Wherever feasible, identifiers will be removed from study-related information. 
A Certificate of Confidentiality will be obtained, because the research could place the subject at risk 
of criminal or civil liability or cause damage to the subject's financial standing, employability, or 
liability. 
A waiver of documentation of consent is being requested, because the only link between the subject 
and the study would be the consent document and the primary risk is a breach of confidentiality. 
(This is not an option for FDA-regulated research.) 
x Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys. 
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identification of subjects. 
Subject Confidentiality 
Subject confidentiality will be maintained throughout the study. Data from questionnaires and other 
completed materials will be available to download from the Qualtrics website account to a password 
protected, secure PC in the PIs office. Identification and contact information will be stored electronically 
in a spreadsheet separate from data that will reside on a password protected computer. Data will be de-
identified before entry into the master spreadsheet. This will be done by assigning each subject (identified 
by email address) a number. The electronic document containing this information will be kept separate 
from the identifying data spreadsheet, but both will be in the secure, password protected PC. 
Sensitive Research Information* 
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record? 
No 
Subject Privacy 
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas confidentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact potential 
participants. The settings in which an individual will be interacting with an investigator. The privacy 
guidelines developed by relevant professions, professional associations and scholarly disciplines (e.g., 
psychiatry, genetic counseling, oral history, anthropology, psychology).  
We will collect e-mail addresses so that we can be in contact with participants and can e-mail them about 
their group assignment and follow-up questionnaires. If a subject indicates that they are actively suicidal 
at any point during the study, the PI will contact them via email to inquire as to their safety and to offer 
referrals to local mental health services. However, no further action will be taken that might compromise 
the subject's privacy. 
Data Disclosure 
Will the data be disclosed to anyone who is not listed under Personnel? 
Subjects who experience any technical difficulties with the app will be invited to contact the tech support 
people at Bold Health. This should not involve disclosure of any PHI, however. 

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Data Protection* 
Name 
Street address, city, county, precinct, zip code, and equivalent geocodes 
All elements of dates (except year) for dates directly related to an individual and all ages over 89 
Telephone and fax number 
x Electronic mail addresses 
Social security numbers 
Medical record numbers 
Health plan ID numbers 
Account numbers 
Certificate/license numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
Device identifiers/serial numbers 
Web addresses (URLs) 
Internet IP addresses 
Biometric identifiers, incl. finger and voice prints 
Full face photographic images and any comparable images 
Any other unique identifying number, characteristic, or code 
None 
Does your research request both a waiver of HIPAA authorization for collection of patient information and 
involve providing Protected Health Information ("PHI") that is classified as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a recipient 
outside of the University of Pennsylvania covered entity? 
No 
Tissue Specimens Obtained as Part of Research* Are 
Tissue Specimens being obtained for research? 
No 
Tissue Specimens - Collected during regular care* 
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)? 
No 
Tissue Specimens - otherwise discarded* 
Would specimens otherwise be discarded? 
No 
Tissue Specimens - publicly available* Will 
tissue specimens be publicly available? 
No 
Tissue Specimens - Collected as part of research protocol* Will 
tissue specimens be collected as part of the research protocol? 
No 
Tissue Specimens - Banking of blood, tissue etc. for future use* Does 
research involve banking of blood, tissue, etc. for future use? 
No 
Genetic testing 
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision of 

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genetic counseling. Describe how subject confidentiality will be protected Note: If no genetic testing is to 
be obtained, write: "Not applicable." 
NA 
Consent 
1. Consent Process 
Overview 
We will recruit study participants via online support groups, and online message boards. Interested parties 
will click on a link to the study Qualtrics page, which will start with the consent form/statement of research 
and only then ask subjects to complete all the baseline questionnaires. If subjects have concerns about the 
study they are welcome to contact the PI at any time with questions and are, of course, free to withdraw 
from the study at any point. 
Children and Adolescents 
NA 
Adult Subjects Not Competent to Give Consent 
NA 
2. Waiver of Consent 
Waiver or Alteration of Informed Consent* 
Waiver of written documentation of informed consent: the research presents no more than minimal risk of 
harm to subjects and involves no procedures for which written consent is normally required outside of the 
research context 
Minimal Risk* 
Impact on Subject Rights and Welfare* 
Waiver Essential to Research* 
Additional Information to Subjects 
Written Statement of Research* 
Yes 
If no written statement will be provided, please provide justificiation 
The following documents are currently attached to this item: 
Written Statement of Research (consentform-shamappversion.docx) 
Risk / Benefit 
Potential Study Risks 
There are some risks to taking part in this study. Participants may find themselves more aware of physical 
sensations and IBS symptoms for a period of time after using the app. They will also be asked to think in 
new ways about problems and situations that might come up in their life, including IBS itself. Sometimes 
it can be uncomfortable or even scary to think about things differently, or to practice new skills. In the 
event that a subject indicates active suicidal ideation on the BDI-II (a score of 2 or 3 on item 9) they will 

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be contacted by the study PI who will conduct a risk assessment and offer referrals to local mental health 
resources. 
Potential Study Benefits 
There are a few potential benefits of participating in this research study. Subjects will have the opportunity 
to use an evidence based digital self-help app for IBS at no cost that incorporates elements of a number of 
empirically supported treatments for IBS. The treatment may help reduce levels of depression, anxiety, 
and symptom severity as well as increase their overall quality of life. The purpose of this study is to test 
the acceptability and efficacy of a novel digital self-help app. Apps like this one are proliferating in the 
digital space, and it is incredibly important that they be tested for actual efficacy. The results of the study 
will provide researchers and clinicians with better understanding of whether or not digital self-help apps 
can be another treatment option for those with IBS. 
Alternatives to Participation (optional) 
Not to partcipate. 
Data and Safety Monitoring 
NA 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
Risk / Benefit Assessment 
There is minimal risk to subjects for participating. There are potential benefits to subjects from completing 
the treatment. There are also broad benefits to this population as a whole from determining whether such 
digital based apps can be of help in the management of IBS. 
General Attachments 
The following documents are currently attached to this item: 
There are no documents attached for this item.