Psychological support as an intervention in IBD fatigue management
Research type
Research Study
Full title
The efficacy of a structured psychoeducational inflammatory bowel disease group on the control of fatigue in an adult outpatient setting for patients with objectively quiescent disease.
IRAS ID
188705
Contact name
PJ Hamlin
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 5 days
Research summary
Fatigue is a very frequently reported symptom in patients with inflammatory bowel disease, assumed to be related to active disease. However, 5 out of every 10 patients with IBD that is felt to be in remission report fatigue. This can have far-reaching implications for patients in their everyday lives.The aim of our study is to assess the effect of a structured support and educational programme on levels of fatigue in patients with inactive IBD.Patients will be approached in the out-patient or telephone clinics and the study will be explained with written information and any questions will be answered. If they agree to being involved they will be asked to complete the fatigue and a number of other questionnaires in addition to having the standard assessment of symptoms, blood tests and a stool specimen. Patients with active disease will be excluded from the subsequent group interventions but the data they have provided to this point will still be helpful in our understanding of fatigue in IBD. Patients identified as being in remission following the initial assessments will be offered the opportunity to be involved in the next stage of the study. The stool samples will also be analysed for the microbiome ie which bacteria are present as some studies suggest that patients with IBD may have a reduced diversity of bacteria in their intestines.
Half of this group will be randomised to active intervention and half will act as a control group for the rest of the study. The active intervention will involve completion of activity diaries over the following two weeks and then analysis of the diaries and agreement on behaviour changes designed to help fatigue. This will be supported by written information and three, monthly small group sessions to reinforce and support these changes.At the end of the study all patients will again complete the fatigue and quality of life questionnaires and have their disease activity assessed by symptom scores, blood and stool tests. The baseline results and the final results will be analysed to see if there is any improvement in fatigue in the group undergoing the programme of support and behaviour change
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0235
Date of REC Opinion
19 Sep 2016
REC opinion
Further Information Favourable Opinion