Irritable Bowel Syndrome (IBS)MahanaPilotNCT07008404
Feasibility of an Online Cognitive Behavioural Therapy Application (Mahana IBS™, Mahana Therapeutics) in the Management of Irritable Bowel Syndrome
A study testing online cognitive behavioral therapy in people with Irritable Bowel Syndrome (IBS), run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Irritable bowel syndrome (IBS) is a very common condition where patients suffer from recurrent episodes of tummy pain associated with the way the bowel works (either constipation, diarrhoea, or a mix of both). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- online cognitive behavioral therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2024to 28 Feb 2025
- 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
- Patients capable of giving informed consent
- Older than 18 years of age
- Patients referred by their GP to secondary/tertiary care with clinical symptoms of IBS (as per NICE guidelines)
- Have regular access to a device with internet
Who cannot join
- Patients with concurrent organic gastrointestinal disease (inflammatory bowel disease, coeliac disease, cancer)
- Concurrent major confounding condition, e.g., alcohol or substance abuse in the last 2 years (clinician's judgement)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Translational Medical Sciences
Nottingham, UK, NG7 2UH
About this study
Official title: A Pilot Study to Assess the Feasibility of an Online Cognitive Behavioural Therapy Application (Mahana IBS™, Mahana Therapeutics) in the Management of Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a very common condition where patients suffer from recurrent episodes of tummy pain associated with the way the bowel works (either constipation, diarrhoea, or a mix of both). The cause of this condition is still unclear, but it has been shown that, for some people their bowel is more sensitive to normal things like meals and stress. Studies have confirmed that psychological therapies are helpful for IBS. Cognitive behavioural therapy (CBT) has been shown to be one of the most helpful over the long term. CBT is a type of talking therapy that helps patients to examine their thoughts, feelings, and behaviours, with a view to change some of them. CBT can help patients to influence their physical IBS symptoms with the help of this therapy. The National Institute for Health and Care Excellence (NICE) recommends CBT in patients who not respond to medications and experience ongoing symptoms. A recent large study conducted in UK has demonstrated that an online version of this CBT, delivered with the help of a therapist, was effective in treating symptoms of IBS. However, in the UK, there is a lack of therapists to support the online version.
A small study conducted in USA has demonstrated that an unguided version of this online CBT (called Mahana IBS) could be as effective as the therapist guided one. This study was small and only enrolled patients who self-referred. This does not reflect what normally happens in clinical practice where patients are normally proposed a treatment by a clinician.
There is a plan tu run a multicentre study in the UK to show that Mahana IBS works (as a mobile/tablet app) for patients with IBS, in clinical practice. Before running this study, it is necessary to get some experience of its use. So, in this pilot study, the aim is to find out if it is feasible to use this CBT app in real-world clinical practice in UK, and whether this improves IBS symptoms and mental health status. In particular the aim is to understanding whether UK patients normally seen in hospital are interested in using this CBT app, can use and complete the planned CBT course, and whether this helps them improving their IBS symptoms and mental health status. Patients will be recruited from Nottingham University Hospital Trust, and the plan is to recruit 60 patients with a diagnosis of IBS.
Read the detailed description
In this pilot study, the aim is to include IBS patients as would be typically encountered in real-world, UK healthcare settings to evaluate the response to the unguided Mahana IBS™, Mahana Therapeutics app-based CBT application for the management of IBS. The results of this pilot study would provide the basis to conduct a feasibility randomised-controlled trial in secondary care settings to evaluate the current barriers/facilitators to the use of Mahana IBS™ in the real-world clinical practice, as well as obtain information to decide the primary endpoint to be used in a definitive randomised controlled, cost-effectiveness trial comparing the use the app (experimental arm) vs. a treatment as usual (control arm). This study would also provide data on the resources required, including the necessary study time scale;
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- online cognitive behavioral therapy
- Keywords
- CBT, pilot study
- 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.
online cognitive behavioral therapyDevice
unguided online cognitive behavioral therapy app
| Study group | Role | What they receive |
|---|---|---|
| CBT | Other | online cognitive behavioral therapy Receives: Device: online cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rate of patients provided with the Mahana IBS™ application
number of patients completing the entire course of the treatment
Measured: from enrollment to end of treatment at 12 weeks
Secondary outcomes (3)
change in the IBS symptom severity scale score for patients
difference between score at baseline and at the end of treatment, scale from 0 to 500, where 500 means worse score
Measured: From enrollment to the end of treatment at 12 weeks
change in the generalised anxiety and depression score-7
difference between the score at baseline and at the end of the treatment, scale from 0 to 21, where 21 means worse score
Measured: rom enrollment to the end of treatment at 12 weeks
change in the patient health questionnaire-9 score
difference in score between baseline and end of the treatment, scale from 0 to 27, where 27 means worse score
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start17 Jan 2024
- Primary completion19 Feb 2025
- Study completion28 Feb 2025
Why it stopped: Producer decided to stop commercialization of the Mahana app
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008404
- Sponsor's protocol ID
- 23GA006
- Other IDs
- IRAS number: 325405
- Acronym
- MahanaPilot
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Gerstein HC, Sattar N, Rosenstock J, Ramasundarahettige C, Pratley R, Lopes RD, Lam CSP, Khurmi NS, Heenan L, Del Prato S, Dyal L, Branch K; AMPLITUDE-O Trial Investigators. Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med. 2021 Sep 2;385(10):896-907. doi: 10.1056/NEJMoa2108269. Epub 2021 Jun 28.
PubMed 34215025Everitt H, Moss-Morris R, Sibelli A, Tapp L, Coleman N, Yardley L, Smith P, Little P. Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website. BMC Gastroenterol. 2013 Apr 21;13:68. doi: 10.1186/1471-230X-13-68.
PubMed 23602047Butt MF, Reghefaoui M, Bush D, Aliyu A, Darie AM, Mohanan A, Sibelli A, Card TR, Corsetti M. Outcomes for a digital prescription mobile application for adults with irritable bowel syndrome: an uncontrolled trial. BMC Gastroenterol. 2026 Jun 11;26(1):395. doi: 10.1186/s12876-026-04964-6.
PubMed 42271261
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility of an Online Cognitive Behavioural Therapy Application (Mahana IBS™, Mahana Therapeutics) in the Management of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07008404
- Acronym / sponsor ID
- MahanaPilot / 23GA006
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- CBT, pilot study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Producer decided to stop commercialization of the Mahana app
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 6 Jun 2025 (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.
Irritable bowel syndrome (IBS) is a very common condition where patients suffer from recurrent episodes of tummy pain associated with the way the bowel works (either constipation, diarrhoea, or a mix of both). The cause of this condition is still unclear, but it has been shown that, for some people their bowel is more sensitive to normal things like meals and stress. Studies have confirmed that psychological therapies are helpful for IBS. Cognitive behavioural therapy (CBT) has been shown to be one of the most helpful over the long term. CBT is a type of talking therapy that helps patients to examine their thoughts, feelings, and behaviours, with a view to change some of them. CBT can help patients to influence their physical IBS symptoms with the help of this therapy. The National Institute for Health and Care Excellence (NICE) recommends CBT in patients who not respond to medications and experience ongoing symptoms. A recent large study conducted in UK has demonstrated that an online version of this CBT, delivered with the help of a therapist, was effective in treating symptoms of IBS. However, in the UK, there is a lack of therapists to support the online version.
A small study conducted in USA has demonstrated that an unguided version of this online CBT (called Mahana IBS) could be as effective as the therapist guided one. This study was small and only enrolled patients who self-referred. This does not reflect what normally happens in clinical practice where patients are normally proposed a treatment by a clinician.
There is a plan tu run a multicentre study in the UK to show that Mahana IBS works (as a mobile/tablet app) for patients with IBS, in clinical practice. Before running this study, it is necessary to get some experience of its use. So, in this pilot study, the aim is to find out if it is feasible to use this CBT app in real-world clinical practice in UK, and whether this improves IBS symptoms and mental health status. In particular the aim is to understanding whether UK patients normally seen in hospital are interested in using this CBT app, can use and complete the planned CBT course, and whether this helps them improving their IBS symptoms and mental health status. Patients will be recruited from Nottingham University Hospital Trust, and the plan is to recruit 60 patients with a diagnosis of IBS.
Detailed description
In this pilot study, the aim is to include IBS patients as would be typically encountered in real-world, UK healthcare settings to evaluate the response to the unguided Mahana IBS™, Mahana Therapeutics app-based CBT application for the management of IBS. The results of this pilot study would provide the basis to conduct a feasibility randomised-controlled trial in secondary care settings to evaluate the current barriers/facilitators to the use of Mahana IBS™ in the real-world clinical practice, as well as obtain information to decide the primary endpoint to be used in a definitive randomised controlled, cost-effectiveness trial comparing the use the app (experimental arm) vs. a treatment as usual (control arm). This study would also provide data on the resources required, including the necessary study time scale;
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT | Other | Device: online cognitive behavioral therapyonline cognitive behavioral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients capable of giving informed consent
- Older than 18 years of age
- Patients referred by their GP to secondary/tertiary care with clinical symptoms of IBS (as per NICE guidelines)
- Have regular access to a device with internet
Key exclusion criteria (3 listed)
- Patients with concurrent organic gastrointestinal disease (inflammatory bowel disease, coeliac disease, cancer)
- Concurrent major confounding condition, e.g., alcohol or substance abuse in the last 2 years (clinician's judgement)
- 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 |
|---|---|---|
| online cognitive behavioral therapyunguided online cognitive behavioral therapy app | Device | CBT |
Primary outcome
retention rate of patients provided with the Mahana IBS™ application
Time frame: from enrollment to end of treatment at 12 weeks
number of patients completing the entire course of the treatment
3 secondary outcomes
change in the IBS symptom severity scale score for patients
Time frame: From enrollment to the end of treatment at 12 weeks
change in the generalised anxiety and depression score-7
Time frame: rom enrollment to the end of treatment at 12 weeks
change in the patient health questionnaire-9 score
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study was stopped early (reason given: Producer decided to stop commercialization of the Mahana app). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 34215025Gerstein HC, Sattar N, Rosenstock J, Ramasundarahettige C, Pratley R, Lopes RD, Lam CSP, Khurmi NS, Heenan L, Del Prato S, Dyal L, Branch K; AMPLITUDE-O Trial Investigators. Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med. 2021 Sep 2;385(10):896-907. doi: 10.1056/NEJMoa2108269. Epub 2021 Jun 28.
- Background: PubMed 23602047Everitt H, Moss-Morris R, Sibelli A, Tapp L, Coleman N, Yardley L, Smith P, Little P. Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website. BMC Gastroenterol. 2013 Apr 21;13:68. doi: 10.1186/1471-230X-13-68.
- Derived from this study: PubMed 42271261Butt MF, Reghefaoui M, Bush D, Aliyu A, Darie AM, Mohanan A, Sibelli A, Card TR, Corsetti M. Outcomes for a digital prescription mobile application for adults with irritable bowel syndrome: an uncontrolled trial. BMC Gastroenterol. 2026 Jun 11;26(1):395. doi: 10.1186/s12876-026-04964-6.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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 online cognitive behavioral therapy in people with Irritable Bowel Syndrome (IBS), run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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 4 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: stopped early, as of the sponsor's last update on 22 Jun 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 Kingdom. 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 was stopped early (reason given: Producer decided to stop commercialization of the Mahana app). Results are not available in the source record.
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?
retention rate of patients provided with the Mahana IBS™ application (time frame: from enrollment to end of treatment at 12 weeks). 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 NCT07008404, which also lists 3 linked publications.
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 22 Jun 2025.