Feasibility of an Online Cognitive Behavioural Therapy Application (Mahana IBS™, Mahana Therapeutics) in the Management of Irritable Bowel Syndrome (MahanaPilot)

June 17, 2025 updated by: Nottingham University Hospitals NHS Trust

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • UK
      • Nottingham, UK, United Kingdom, NG7 2UH
        • Translational Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CBT
online cognitive behavioral therapy
Device: online cognitive behavioral therapy
unguided online cognitive behavioral therapy app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from enrollment to end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the IBS symptom severity scale score for patients
Time Frame: From enrollment to the end of treatment at 12 weeks
difference between score at baseline and at the end of treatment, scale from 0 to 500, where 500 means worse score
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
difference between the score at baseline and at the end of the treatment, scale from 0 to 21, where 21 means worse score
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
difference in score between baseline and end of the treatment, scale from 0 to 27, where 27 means worse score
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Actual)

February 19, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

June 3, 2025

First Posted (Actual)

June 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23GA006
  • IRAS number: 325405 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Access Criteria

after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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