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

NCT07008404 | Terminated

• 2 other identifiers: 23GA006IRAS number: 325405
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

CBT; pilot study

Outcome Measures

Primary Outcomes (1)

• retention rate of patients provided with the Mahana IBS™ application

  number of patients completing the entire course of the treatment

  from enrollment to end of treatment at 12 weeks

Secondary Outcomes (3)

• change in the IBS symptom severity scale score for patients

  From enrollment to the end of treatment at 12 weeks

• change in the generalised anxiety and depression score-7

  rom enrollment to the end of treatment at 12 weeks

• change in the patient health questionnaire-9 score

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

CBT

OTHER

online cognitive behavioral therapy

Device: online cognitive behavioral therapy

Interventions

online cognitive behavioral therapy DEVICE

unguided online cognitive behavioral therapy app

CBT

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male and female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Translational Medical Sciences

Nottingham, UK, NG7 2UH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34215025 BACKGROUND

• Everitt 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.

  PMID: 23602047 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 6, 2025
• Study Start: January 17, 2024
• Primary Completion: February 19, 2025
• Study Completion: February 28, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: after publication

Locations

GB (1)