MahanaPilot
Research type
Research Study
Full title
A pilot study to assess the feasibility of an online cognitive behavioral therapy application (Mahana IBS™, Mahana Therapeutics) in the management of irritable bowel syndrome
IRAS ID
325405
Contact name
Maura Corsetti
Contact email
Sponsor organisation
Nottingham University Hospital Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Background
Irritable bowel syndrome (IBS) is a debilitating gut condition characterised by abdominal pain and altered bowel habit. According to the National Institute for Health and Care Excellence (NICE), up to 1 in 5 people are affected by IBS and between 1.6 million and 3.9 million people per year consult for IBS in England and Wales. Cognitive behavioural therapy (CBT) developed specifically for IBS is an effective talking treatment. It is not often available to patients due to a lack of trained therapists. A web-based version of CBT for IBS has shown large improvements in symptoms at 12-months used alongside therapist support (ACTIB Trial) when compared to treatment as usual. We plan to evaluate the use of a new version of this app, Mahana IBS™, without therapist support in a real-world setting to manage IBS symptoms in patients referred to secondary care. Data arising from this project will help us to perform a definitive randomised controlled trial in future.Primary aim:
number of patients provided with the access to the Mahana IBS™ app completing the course.
Secondary aims:
1. To calculate the change in the IBS symptom severity scale (IBS-SSS) score for patients at baseline and at three months.
2. To calculate the change in the generalised anxiety and depression score-7 (GAD-7) for patients at baseline and at three months.
3. To calculate the change in the patient health questionnaire-9 (PHQ-9) score for patients at baseline and at three months.Methodology
Patients referred for symptoms of IBS (as per NICE guidelines) to Queen’s Medical Centre (Nottingham University Hospitals NHS Trusts) will be invited to participate in the study. Patient reported outcome scores will be measured at baseline and at three months following recruitment. The Mahana IBS™ App takes between 8 to 12 weeks to complete.Dissemination
Outcomes will be disseminated in medical journals and presented at international conferences.Lay summary of study results:
Background
Behavioural therapies such as hypnotherapy and cognitive behavioural therapy (CBT) are effective in the management of irritable bowel syndrome (IBS). Mahana™ IBS is a mobile phone application designed to deliver 10 weeks (three months) of gut-directed CBT to adults with IBS.Objectives of the study were
To evaluate patient compliance with the Mahana™ mobile phone application and the change in gastrointestinal and psychological symptoms in a real-world UK setting.Methods
This single-centre prospective study recruited adults with IBS from a tertiary care outpatient setting. At baseline and three-month follow-up, patients completed questionaries assessing gastrointestinal symptoms (IBS symptom severity scale [IBS-SSS]), depression (patient health questionnaire-9 [PHQ-9]), and anxiety (generalised anxiety disorder-7 [GAD-7]).Results
Thirty patients (20/30 female, mean age 44.57) consented to treatment and completed pre-intervention questionnaires, among whom 20 (66.7%) provided follow-up questionnaire data. Among the 20 individuals with two-point data (who attended two visits), there was a statistically significant reduction in the IBS-SSS (P<0.001), GAD-7 (P=0.02), and PHQ-9 (P=0.04) scores. Fourteen (70%) patients reported a clinically significant improvement (≥50 point reduction) in the IBS-SSS; these individuals tended to be older (P=0.04) and male (P=0.04). Patients with IBS-diarrhoea reported the greatest improvement in the IBS-SSS versus those with IBS-constipation and IBS-mixed subtypes.Conclusion
This study provides preliminary evidence that the Mahana™ IBS CBT application is associated with a statistically significant improvement in gastrointestinal and psychological symptoms in a real-world UK clinical setting.REC name
South East Scotland REC 02
REC reference
23/SS/0091
Date of REC Opinion
1 Nov 2023
REC opinion
Further Information Favourable Opinion