| Summary: | Background: Fatigue is a complex, multifactorial and multidimensional phenomenon, which has been described as a persistent overwhelming sense of tiredness, weakness, or exhaustion. It is the third most common concern for patients with inflammatory bowel disease (IBD), experienced by 44-86% of patients with active disease and 22-41% of patients in remission. Fatigue can have a significant negative impact on patients’ quality of life (QoL). The aetiology of fatigue is not well understood. Interventions for IBD-fatigue are scarce, demonstrating limited benefit, and have not been implemented into clinical practice. The development of a theoretically-driven intervention to improve fatigue is a primary need for this population. Methods: The overall aim of the study was to develop a complex intervention for the management of IBD-fatigue and test its feasibility and potential efficacy. Guided by self-regulation theory and the Medical Research Council framework for development, feasibility and piloting phases, four steps were conducted in an iterative process. A systematic review study (Paper 1), identified aetiological modifiable factors which had already been or could be targeted by health interventions to improve IBD-fatigue. A quantitative cross-sectional study (n = 182) (Paper 2), evaluated the potential relationship between the identified modifiable cognitive-behavioural factors and IBD-fatigue. Patient and public involvement activities informed the adaptation of a cognitive-behavioural therapy (CBT) intervention for multiple-sclerosis fatigue to IBD-fatigue. Lastly, a two-arm pilot randomised controlled trial (RCT) with a nested qualitative study (Papers 3 and 4) assessed the feasibility and initial estimates of efficacy of a CBT manual with 8, weekly therapist telephone session (n = 15) vs. a fatigue information sheet without help (n = 16). Results: Initial estimates of efficacy with per protocol analysis showed a reduction in fatigue scores and an improvement in QoL scores at 3-months post-randomisation. The difference in change in scores between groups was significant for impact of fatigue. The intervention was acceptable to participants and feasible for therapists to deliver. Healthcare professionals working with IBD patients reported that the intervention would be broadly applicable but time, finance and training constraints may limit its implementation in routine clinical care. Conclusions: CBT for IBD-fatigue is feasible and has a potential for improvement of the impact of fatigue on daily activities. A large-scale RCT is needed to investigate the size and longevity of treatment gains and the cost-effectiveness of the therapy. Incorporating changes to the protocol and developing an online intervention may be an effective way to overcome the barriers to implementation identified by healthcare professionals and test the generalisability of the intervention to IBD-clinical practice.
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