IBS - Irritable Bowel SyndromeNCT04723056
Zemedy Application for Irritable Bowel Syndrome
A study testing Use of Zemedy Application in people with IBS - Irritable Bowel Syndrome, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Use of Zemedy Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 8 Mar 2024
- 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
- Male and female patients >=18 years old.
- Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS.
- English proficiency (in order to understand use of the application.
- Patient must be on a stable regimen for IBS for at least 30 days.
- Patients must own a smartphone (iOS or Android) in order to participate in the CBT application.
Who cannot join
- Laboratory or imaging evidence of an alternative explanation of patient's symptoms.
- Active gastrointestinal disease such as Crohn's disease, ulcerative colitis, history of complete colon resection, acute infection, or any disease that precludes participation in CBT application.
- Patient already undergoing cognitive behavioral therapy.
- Psychiatric hospitalization within 10 years.
- Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse.
- Active (within the past 3 months) suicidal ideation.
Show all 9Show fewer
- Prisoners or other detained individuals.
- Adults unable to consent.
- Pregnant people.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Redwood City, California, 94063
About this study
Official title: Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome
The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.
Read the detailed description
Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors.
Treatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.
CBT has been shown to reduce the severity of intractable IBS symptoms by as much as 70%. The investigators hope to learn whether the Zemedy mobile application is effective in the reduction of IBS. This will be measured based on their IBS Symptom Severity Scores (SSS) at week 8 compared to baseline.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Use of Zemedy Application
- Keywords
- Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Self Help
- 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.
Use of Zemedy ApplicationDevice
8 weeks of CBT via the Zemedy Application.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (TAU only) | No intervention | Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy. |
| Experimental (TAU plus CBT) | Experimental | Subjects who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU). Receives: Device: Use of Zemedy Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS at 8 Weeks
Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; >300 = severe).
Measured: Baseline and at Week 8.
Secondary outcomes (8)
IBS-SSS at 24 Weeks
Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 24 compared to baseline. Score range: 0-500. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; >300 = severe).
Measured: Baseline and at Week 24
Hospital Anxiety and Depression Scale (HADS) - Depression Score
Assesses mood measured by the total distress score (score range: 0 to 21; <7 normal, 8-14 borderline, 15 or >15, abnormal).
Measured: Baseline, week 8 and week 24
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Assesses mood measured by the total distress score (score range: 0 to 21; <7 normal, 8-14 borderline, 15 or >15, abnormal)
Measured: Baseline, week 8 and week 24
Cohen Perceived Stress Questionnaire (PSQ)
Measures degree situation's in one's life are seen as stressful (score range: 0 to 40; 0-13 = low stress, 14-26 = moderate stress, 27-40 = high stress)
Measured: baseline, 24 weeks
Work and Social Adjustment Scale (WSAS)
Measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. Score range: 0 to 40 (<10 subclinical/mild, 10-20 significant, >20 severe).
Measured: Baseline, week 24
Subject's Global Assessment of Relief (SGA)
Assesses global symptoms relief asking the question, "Overall, how do you feel?". Score range: -2 (no pain) to +2 (severe pain/discomfort).
Measured: Baseline, Week 24
Work Productivity and Activity Impairment (WPAI) Questionnaire
Assesses work productivity based on percentage of work days taken off due to health
Measured: Baseline, 8 weeks, 24 weeks
Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start15 Oct 2021
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Why it stopped: Loss of funding
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.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Parallel groups
- Model description
- Randomized trial comparing Zemedy CBT app vs. Treatment as usual
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Bold Health Inc.
- Responsible party
- Principal investigator, Linda Nguyen, Stanford University
- Investigators
- Linda Nguyen, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723056
- Sponsor's protocol ID
- 59209
- Status last verified
- May 2025
- First submitted
- 20 Jan 2021
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zemedy - Evaluation of Zemedy, a Cognitive Behavioral Therapy-based Digital Therapeutic Application for the Treatment of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04723056
- Acronym / sponsor ID
- 59209
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Self Help
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Bold Health Inc.
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 28 May 2025
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 the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.
Detailed description
Irritable bowel syndrome (IBS) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. The pathophysiology of IBS can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors.
Treatment of IBS is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (CBT) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. Therefore the purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.
CBT has been shown to reduce the severity of intractable IBS symptoms by as much as 70%. The investigators hope to learn whether the Zemedy mobile application is effective in the reduction of IBS. This will be measured based on their IBS Symptom Severity Scores (SSS) at week 8 compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial comparing Zemedy CBT app vs. Treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Control Group (TAU only) | No intervention | –Treatment as Usual (TAU) for IBS patients are tailored to each individual's needs and may involve treatment such as: dietary modification, exercise, medication, and anti-diarrheal therapy. |
| Experimental (TAU plus CBT) | Experimental | Device: Use of Zemedy ApplicationSubjects who are in the Experimental Group will receive 8 weeks of CBT from the Zemedy mobile application in addition to their treatment as usual (TAU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients >=18 years old.
- Meet Rome IV criteria for IBS for at least 6 months. No restrictions on type of IBS.
- English proficiency (in order to understand use of the application.
- Patient must be on a stable regimen for IBS for at least 30 days.
- Patients must own a smartphone (iOS or Android) in order to participate in the CBT application.
Key exclusion criteria (9 listed)
- Laboratory or imaging evidence of an alternative explanation of patient's symptoms.
- Active gastrointestinal disease such as Crohn's disease, ulcerative colitis, history of complete colon resection, acute infection, or any disease that precludes participation in CBT application.
- Patient already undergoing cognitive behavioral therapy.
- Psychiatric hospitalization within 10 years.
- Current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse.
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 |
|---|---|---|
| Use of Zemedy Application8 weeks of CBT via the Zemedy Application. | Device | Experimental (TAU plus CBT) |
Primary outcome
IBS-SSS at 8 Weeks
Time frame: Baseline and at Week 8.
Change in IBS symptoms based on the change in IBS symptom severity score (IBS-SSS) score at week 8 compared to baseline. Score range: 0-500. Higher score corresponds to more severe symptoms (75-175 = mild, 176-300 - moderate; >300 = severe).
8 secondary outcomes
IBS-SSS at 24 Weeks
Time frame: Baseline and at Week 24
Hospital Anxiety and Depression Scale (HADS) - Depression Score
Time frame: Baseline, week 8 and week 24
Hospital Anxiety and Depression Scale (HADS) - Anxiety Score
Time frame: Baseline, week 8 and week 24
Cohen Perceived Stress Questionnaire (PSQ)
Time frame: baseline, 24 weeks
Work and Social Adjustment Scale (WSAS)
Time frame: Baseline, week 24
Subject's Global Assessment of Relief (SGA)
Time frame: Baseline, Week 24
Work Productivity and Activity Impairment (WPAI) Questionnaire
Time frame: Baseline, 8 weeks, 24 weeks
Number of Participants Who Had an Urgent Care, Emergency Department, or Physician Appointment Due to IBS
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Linda Nguyen, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Zemedy Application in people with IBS - Irritable Bowel Syndrome, run by Stanford University 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 28 May 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?
Yes. Results are posted in the registry (first posted 28 May 2025). 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?
IBS-SSS at 8 Weeks (time frame: Baseline and at Week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.