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

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Ki végzi
Nottingham University Hospitals NHS Trust
Azonosító
NCT07008404
A regiszteradat frissítve
2025. június 22.
Eredeti leírás
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 teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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.

ClinicalTrials.gov NCT07008404

Építés alatt, nem éles – Feasibility of an Online Cognitive Behavioural Therapy Application (Mahana IBS™, Mahana Therapeutics) in the Management of Irritable Bowel Syndrome (NCT07008404) – Frontlight Research