Irritable Bowel SyndromeNCT04170686
Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
A study testing Zemedy App for Irritable Bowel Syndrome 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 self-help app for IBS is an acceptable and effective intervention for improving the overall quality of life in patients with Irritable Bowel Syndrome. 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 for Irritable Bowel Syndrome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 28 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of IBS. Own a smart phone. Speak English
Who cannot join
- Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)
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 self-help app for IBS is an acceptable and effective intervention for improving the overall quality of life in patients with Irritable Bowel Syndrome.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Zemedy App for Irritable Bowel Syndrome
- Keywords
- cognitive behavioral therapy, self-help, irritable bowel syndrome
- 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 App for Irritable Bowel SyndromeBehavioural
The Zemedy App for irritable bowel syndrome is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace. Receives: Behavioral: Zemedy App for Irritable Bowel Syndrome |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome Quality of Life
A self-report measure of health related quality of life (HRQL) in people with irritable bowel syndrome. Scores range from 0 to 100. Higher scores are a worse outcome.
Measured: 8 weeks
Gastrointestinal Symptom Rating Scale
a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.
Measured: 8 weeks
Secondary outcomes (7)
Visceral Sensitivity Index
self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome.
Measured: 8 weeks
GI Cognitions Questionnaire
self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome.
Measured: 8 weeks
Fear of Food Questionnaire
self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
Measured: 8 weeks
Patient Health Questionnaire
self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.
Measured: 8 weeks
Depression Anxiety and Stress Scale - Depression Subscale
Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.
Measured: 8 weeks
Depression Anxiety and Stress Scale - Stress Subscale
The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity.
Measured: 8 weeks
Depression Anxiety and Stress Scale - Anxiety Subscale
Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.
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 posted20 Nov 2019
- Study start28 Oct 2019
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- None (open label)
- Enrolment
- 146 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
- Investigators
- Melissa G Hunt, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170686
- Sponsor's protocol ID
- 833848
- Status last verified
- Jan 2021
- First submitted
- 14 Nov 2019
- Last updated
- 16 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunt M, Miguez S, Dukas B, Onwude O, White S. Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 20;9(5):e26152. doi: 10.2196/26152.
PubMed 33872182
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04170686
- Acronym / sponsor ID
- 833848
- Conditions
- Irritable Bowel Syndrome
- Keywords
- cognitive behavioral therapy, self-help, irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Bold Health Inc.
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Posted 24 Dec 2020
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 self-help app for IBS is an acceptable and effective intervention for improving the overall quality of life in patients with Irritable Bowel Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Zemedy App for Irritable Bowel SyndromeParticipants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of IBS. Own a smart phone. Speak English
Key exclusion criteria (1 listed)
- Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)
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 App for Irritable Bowel SyndromeThe Zemedy App for irritable bowel syndrome is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS. | Behavioural | Immediate Treatment |
Primary outcome
Irritable Bowel Syndrome Quality of Life
Time frame: 8 weeks
A self-report measure of health related quality of life (HRQL) in people with irritable bowel syndrome. Scores range from 0 to 100. Higher scores are a worse outcome.
Gastrointestinal Symptom Rating Scale
Time frame: 8 weeks
a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.
7 secondary outcomes
Visceral Sensitivity Index
Time frame: 8 weeks
GI Cognitions Questionnaire
Time frame: 8 weeks
Fear of Food Questionnaire
Time frame: 8 weeks
Patient Health Questionnaire
Time frame: 8 weeks
Depression Anxiety and Stress Scale - Depression Subscale
Time frame: 8 weeks
Depression Anxiety and Stress Scale - Stress Subscale
Time frame: 8 weeks
Depression Anxiety and Stress Scale - Anxiety Subscale
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33872182Hunt M, Miguez S, Dukas B, Onwude O, White S. Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 20;9(5):e26152. doi: 10.2196/26152.
- Individual participant dataSharing planned: No
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.
Melissa G Hunt, PhD principal investigator
University of Pennsylvania
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 for Irritable Bowel Syndrome 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 1 inclusion and 1 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 16 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 24 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (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 NCT04170686, 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 16 Feb 2021.