MODIFY Fatigue: pilot intervention in inflammatory bowel disease v1
Research type
Research Study
Full title
Management of Inflammatory Bowel Disease-Fatigue: a Pilot Cognitive-Behavioural Therapy Intervention
IRAS ID
212340
Contact name
Christine Norton
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN17917944
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
Fatigue is one of the most prevalent and burdensome symptoms for patients with inflammatory bowel disease (IBD). However, to date interventions for the management of IBD-fatigue are sparse, with only short-term effects measured, and have limitations which have prevented their implementation within the resource constraints of the National Health Service. In other long-term conditions, there is robust evidence from randomised controlled trial (RCT) interventions to suggest that modifying maladaptive cognitions and behaviours through cognitive-behavioural therapy (CBT) could be a viable option for the management of fatigue. Drawing from these interventions can thus allow for the development of new evidence-based treatments in IBD without reinventing the wheel. Modifying an existing intervention developed for patients with multiple sclerosis (MS), the current pilot RCT aims to determine the feasibility and the initial estimates of efficacy of a CBT-fatigue intervention in patients with IBD. Participants will be recruited from outpatient clinics at a hospital in London and randomised individually to two groups: Group 1 (CBT manual, one 60-minute session and seven 30-minute telephone/Skype sessions with a therapist over an eight week period) or Group 2 (Crohn’s and Colitis UK “Fatigue in IBD” booklet to use without therapist help). IBD-specific fatigue (primary outcome), quality of life (secondary outcome) and self-reported disease activity will be collected at baseline, 3, 6 and 12 months post randomisation. Illness perceptions, daytime sleepiness, anxiety and depression as potentially explanatory variables will be collected at baseline and 3-months post-randomisation. Clinical and socio-demographic data will be retrieved from the patients’ medical notes. Post-intervention, semi-structured interviews will be conducted with a subset of the patient sample, the therapist/s delivering the intervention and healthcare professionals working with patients with IBD in order to evaluate their experience and views of the intervention and areas for improvement in future fatigue interventions.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0791
Date of REC Opinion
28 Nov 2016
REC opinion
Further Information Favourable Opinion