Irritable Bowel SyndromeNCT04665271
Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS
A study testing Zemedy App in people with Irritable Bowel Syndrome, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this research is to assess if a new digital 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Zemedy App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-report of physician diagnosis of IBS.
- At least 18 years of age.
Who cannot join
- Severe depression or suicidality
- Comorbid GI disorder such as inflammatory bowel disease or celiac disease.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6018
About this study
The purpose of this research is to assess if a new digital 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.
Read the detailed description
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 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 an education and relaxation training control 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, cross over (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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Zemedy App
- Keywords
- cognitive behavioral therapy
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zemedy AppBehavioural
Digital smart phone app that delivers cognitive-behavioral therapy for IBS
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment - Zemedy App | Experimental | Participants will be given immediate access to the Zemedy app for IBS. Receives: Behavioral: Zemedy App |
| Active Control - Education and Relaxation Training App | Active comparator | Participants will be given access to a education and relaxation training app. After 8 weeks they will then be crossed over to the Zemedy app. Receives: Behavioral: Zemedy App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome Quality of Life (IBSQoL)
IBS specific health related quality of life measure. Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome)
Measured: 8 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal Symptom Rating Scale. Scale scores range from 0-78 with high scores representing worse GI symptoms.
Measured: 8 weeks
Secondary outcomes (5)
GI-Cognitions Questionnaire (GICog)
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)
Measured: 8 weeks
Visceral Sensitivity Index (VSI)
Scale measures anxiety about visceral (gut) sensations. Scale scores range from 0 to 75 with higher scores representing more anxiety.
Measured: 8 weeks
Fear of Food Questionnaire (FFQ)
Scale measures fear of food and aversive consequences of eating. Scale scores range from 0-90 with higher scores representing more fear and impairment.
Measured: 8 weeks
Beck Depression Inventory (BDI)
Measures depressive symptoms. Scale scores range from 0 to 63 with higher scores representing more severe depressive symptoms.
Measured: 8 weeks
Work Productivity and Activity Impairment (WPAI)
Measures occupational impairment stemming from a health condition. scores range from 0 to 30 with higher scores representing more impairment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Mar 2021
- Primary completion30 Dec 2023
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Active control with cross-over at post-treatment and three month follow-up
- Masking
- None (open label)
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Bold Health Inc.
- Responsible party
- Principal investigator, Melissa Hunt, PhD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665271
- Sponsor's protocol ID
- 844160
- Status last verified
- Nov 2025
- First submitted
- 12 Nov 2020
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunt MG, Dalvie A, Ipek S, Wasman B. Acceptability and efficacy of the Zemedy app versus a relaxation training and meditation app for IBS: protocol for a randomised controlled trial. BMJ Open. 2022 Jan 17;12(1):e055014. doi: 10.1136/bmjopen-2021-055014.
PubMed 35039299
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS
- ClinicalTrials.gov ID
- NCT04665271
- Acronym / sponsor ID
- 844160
- Conditions
- Irritable Bowel Syndrome
- Keywords
- cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Bold Health Inc.
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to assess if a new digital 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.
Detailed description
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 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 an education and relaxation training control 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, cross over (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Active control with cross-over at post-treatment and three month follow-up
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment - Zemedy App | Experimental | Behavioral: Zemedy AppParticipants will be given immediate access to the Zemedy app for IBS. |
| Active Control - Education and Relaxation Training App | Active comparator | Behavioral: Zemedy AppParticipants will be given access to a education and relaxation training app. After 8 weeks they will then be crossed over to the Zemedy app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-report of physician diagnosis of IBS.
- At least 18 years of age.
Key exclusion criteria (3 listed)
- Severe depression or suicidality
- Comorbid GI disorder such as inflammatory bowel disease or celiac disease.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zemedy AppDigital smart phone app that delivers cognitive-behavioral therapy for IBS | Behavioural | Active Control - Education and Relaxation Training App, Immediate Treatment - Zemedy App |
Primary outcome
Irritable Bowel Syndrome Quality of Life (IBSQoL)
Time frame: 8 weeks
IBS specific health related quality of life measure. Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome)
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 8 weeks
Gastrointestinal Symptom Rating Scale. Scale scores range from 0-78 with high scores representing worse GI symptoms.
5 secondary outcomes
GI-Cognitions Questionnaire (GICog)
Time frame: 8 weeks
Visceral Sensitivity Index (VSI)
Time frame: 8 weeks
Fear of Food Questionnaire (FFQ)
Time frame: 8 weeks
Beck Depression Inventory (BDI)
Time frame: 8 weeks
Work Productivity and Activity Impairment (WPAI)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Derived from this study: PubMed 35039299Hunt MG, Dalvie A, Ipek S, Wasman B. Acceptability and efficacy of the Zemedy app versus a relaxation training and meditation app for IBS: protocol for a randomised controlled trial. BMJ Open. 2022 Jan 17;12(1):e055014. doi: 10.1136/bmjopen-2021-055014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zemedy App in people with Irritable Bowel Syndrome, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Quality of Life (IBSQoL) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.