Extrait

Background and study aims Inflammatory bowel disease (IBD) is a term used to describe conditions which cause long-term inflammation (swelling) in the gut. The two main forms of IBD are Crohn’s disease (CD) and ulcerative colitis (UC). Crohn’s disease can affect any part of the gut, but is most commonly at the end of the ileum (the last part of the small intestine) or the colon (the large intestine). Ulcerative colitis generally affects the colon and rectum (the last part of the large intestine). There is currently no cure for these conditions, and so the main aim of treatment is to reduce the symptoms (remission) and prevent the disease from “flaring up” and becoming active again. Even when the disease is in remission, many patients still experience 'irritable bowel syndrome-like' symptoms, such as bloating, diarrhoea and abdominal (tummy) pain. Fatigue (extreme tiredness) is one of the most common and difficult to cope with symptoms for patients with IBD. However currently there are very few ways of managing IBD-fatigue effectively. There is some evidence that cognitive behavioural therapy (a type of talking therapy which helps people to manage their problems by changing the way they think and behave) could be a good way of managing IBD-fatigue. This study aims to find out whether conducting a large study looking at the effectiveness of cognitive behavioural therapy (CBT) for the treatment of IBD-fatigue is feasible, but conducting a small-scale study to see if the study procedures are acceptable. Who can participate? Adults with IBD who are not currently experiencing a disease flare up and are currently experiencing fatigue. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive a CBT manual about the management of fatigue, as well as a 60-minute session and seven 30-minute telephone/Skype sessions with a therapist over an eight week period. Those in the second group receive the Crohn’s and Colitis UK (IBD charity) Fatigue in IBD” Information Sheet to use without therapist help. At the start of the study and then again after 3, 6 and 12 months, participants in both groups complete a number of questionnaires to measure their fatigue, disease activity and quality of life. A small sub-set of 7 patients, therapists and healthcare professionals are also invited for interviews after 3 months in order to evaluate their opinions about the CBT program. What are the possible benefits and risks of participating? There is a possibility that some participants may benefit from an improvement to their fatigue levels. There is a small risk that some participants may become a little distressed when completing the study questionnaires, talking to the therapist or when reading the Fatigue Information Sheet alone, or being interviewed, because thinking about their IBD could be upsetting. Where is the study run from? IBD Centre, Guy's and St Thomas's NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? September 2016 to October 2018 Who is funding the study? Florence Nightingale Faculty of Nursing & Midwifery (Walpole Legacy), Kings College London (UK) Who is the main contact? Miss Micol Artom

Critère d'inclusion

• inflammatory bowel disease

Liens

• isrctn