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

  maura.corsetti@nottingham.ac.uk

• Sponsor organisation

  Nottingham University Hospital Trust

• 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.

• 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