ORIGINAL ARTICLE Fatigue management in patients with IBD: a randomised controlled trial Lauran Vogelaar, 1 Adriaan van’t Spijker, 2 Reinier Timman, 2 Antonie J P van Tilburg, 3 DirkJan Bac, 4 Ton Vogelaar, 2 Ernst J Kuipers, 1,5 Jan J V van Busschbach, 2 Christien J van der Woude 1 1 Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, The Netherlands 2 Department of Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands 3 Department of Gastroenterology and Hepatology, Sint Franciscus Gasthuis, Rotterdam, The Netherlands 4 Department of Gastroenterology and Hepatology, Gelderse Vallei, Ede, The Netherlands 5 Department of Internal Medicine, Erasmus MC, Rotterdam, The Netherlands Correspondence to Lauran Vogelaar, Department of Gastroenterology and Hepatology, Erasmus MC, ‘s Gravendijkwal 230, Room HS 306, Rotterdam 3000 CA, The Netherlands; l.vogelaar@erasmusmc.nl Received 1 May 2013 Revised 20 June 2013 Accepted 24 June 2013 Published Online First 24 July 2013 To cite: Vogelaar L, van’t Spijker A, Timman R, et al. Gut 2014;63:911–918. ABSTRACT Objective To assess the effectiveness of solution- focused therapy (SFT) on fatigue and quality of life (QoL) in patients with fatigued inflammatory bowel disease (IBD). Design Randomised controlled trial in two Dutch hospitals. Patients with IBD with quiescent IBD and with a Checklist Individual Strength—Fatigue (CIS—fatigue) score of ≥35 were enrolled. Patients were 1:1 randomised to receive SFT or care as usual (CAU) for 3 months. Patients were followed for a further 6 months after the SFT. Primary endpoint was defined as changes in fatigue and QoL during follow-up. Secondary endpoints included change in anxiety and depression, medication use, side effects to medication, disease activity, laboratory parameters (C-reactive protein, leucocytes and haemoglobin) and sleep quality. Results Ninety-eight patients were included, of whom 63% were women, mean age was 40.1 years. After the SFT course, 17 (39%) patients in the SFT group had a CIS-fatigue score below 35 compared with eight (18%) of patients in the CAU group (p=0.03). The SFT group also showed a greater reduction in fatigue across the first 6 months compared with the CAU group (CIS- fatigue: p=<0.001 and CIS-total: p=0.001). SFT was associated with a significant higher mean IBD questionnaire change at 3 months (p=0.020). At 9 months, no significant differences between the two groups were observed. Conclusions SFT has a significant beneficial effect on the severity of fatigue and QoL in patients with quiescent IBD. However, this effect diminished during follow-up. INTRODUCTION Inflammatory bowel disease (IBD) can lead to severe, debilitating fatigue which may significantly impair the quality of life (QoL). 1–6 Over 40% of IBD patients suffer from severe fatigue, even during disease remission. 137 Although most patients have persistent fatigue, and psychological factors are known to be associated with fatigue, management strategies focussing on fatigue are lacking and inter- vention studies are scarce. 5–18 Psychological inter- ventions for patients with IBD have previously been applied for multiple goals, such as improving QoL, decreasing depression and decreasing flares. However, none of these studies investigated the effect on fatigue. Furthermore, due to heterogen- eity between studies, it is difficult to draw conclusions on the effectiveness of these interven- tions on QoL. 10–18 Fatigue is also seen in other chronic conditions, such as disease remission after treatment for cancer, rheumatic disease, multiple sclerosis and chronic infectious diseases. 19 20 Especially in former cancer patients, in patients with rheumatic disease and in patients with multiple sclerosis, psychotherapy showed to be effective in reducing fatigue. 21–24 We earlier reported in a pilot study with a small sample size that psychotherapy, especially solution-focused therapy (SFT) in patients with IBD is feasible and reduced fatigue. 25 Therefore, we assessed in a randomised controlled trial whether SFT is more effective in improving fatigue and Qol than care as usual (CAU). METHODS Study design and sample size This randomised controlled trial was designed to evaluate the efficacy of SFT in comparison to CAU Significance of this study What is already known about this subject? ▸ Fatigue can invalidate patients with inflammatory bowel disease (IBD) and contribute to disease burden. ▸ Psychological factors may influence the burden of disease. ▸ Psychotherapy is effective to decrease fatigue in patients with chronic diseases. What are the new findings? ▸ Solution-focused therapy significantly reduces fatigue and, thereby, increases quality of life in patients with IBD. ▸ Solution-focused therapy decreased the fatigue level to values observed in the normal healthy population. How might it impact on clinical practice in the foreseeable future? ▸ The results of this study augment the evidence that psychotherapy is effective to decrease fatigue in quiescent patients with IBD and, therefore, can be used to optimise treatment in such patients. Vogelaar L, et al. Gut 2014;63:911–918. doi:10.1136/gutjnl-2013-305191 911 In fl ammatory bowel disease group.bmj.com on June 8, 2014 - Published by gut.bmj.com Downloaded from