Artom Micol, Czuber-Dochan Wladyslawa, Sturt Jackie, Norton Christine
King's College London, Florence Nightingale Faculty of Nursing & Midwifery, James Clerk Maxwell Building, 57 Waterloo Road, London, SE1 8WA, UK.
Trials. 2017 May 11;18(1):213. doi: 10.1186/s13063-017-1926-3.
Fatigue is one of the most prevalent and burdensome symptoms for patients with inflammatory bowel disease (IBD). Although fatigue increases during periods of inflammation, for some patients it persists when disease is in remission. Compared to other long-term conditions where fatigue has been extensively researched, optimal management of fatigue in patients with IBD is unknown and fatigue has rarely been the primary outcome in intervention studies. To date, interventions for the management of IBD-fatigue are sparse, have short-term effects and have not been implemented within the existing health system. There is a need to integrate current best evidence across different conditions, patient experience and clinical expertise in order to develop interventions for IBD-fatigue management that are feasible and effective. Modifying an existing intervention for patients with multiple sclerosis, this study aims to assess the feasibility and initial estimates of efficacy of a cognitive behavioural therapy (CBT) intervention for the management of fatigue in patients with IBD.
The study will be a two-arm pilot randomised controlled trial. Patients will be recruited from one outpatient IBD clinic and randomised individually to either: Group 1 (CBT manual for the management of fatigue, one 60-min session and seven 30-min telephone/Skype sessions with a therapist over an eight-week period); or Group 2 (fatigue information sheet to use without therapist help). Self-reported IBD-fatigue (Inflammatory Bowel Disease-Fatigue Scale) and IBD-quality of life (United Kingdom Inflammatory Bowel Disease Questionnaire) and self-reported disease activity will be collected at baseline, three, six and 12 months post randomisation. Illness perceptions, daytime sleepiness, anxiety and depression explanatory variables will be collected only at three months post randomisation. Clinical and sociodemographic data will be retrieved from the patients' medical notes. A nested qualitative study will evaluate patient and therapist experience, and healthcare professionals' perceptions of the intervention.
The study will provide evidence of the feasibility and initial estimates of efficacy of a CBT intervention for the management of fatigue in patients with IBD. Quantitative and qualitative findings from the study will contribute to the development and implementation of a large-scale randomised controlled trial assessing the efficacy of CBT interventions for IBD-fatigue.
ISRCTN Registry, ISRCTN17917944 . Registered on 2 September 2016.
疲劳是炎症性肠病（IBD）患者中最常见且负担最重的症状之一。尽管疲劳在炎症发作期会加重，但对一些患者而言，即使疾病缓解时疲劳仍会持续。与其他已对疲劳进行广泛研究的慢性病相比，IBD患者疲劳的最佳管理方法尚不清楚，且疲劳在干预研究中很少作为主要结局。迄今为止，针对IBD相关疲劳的干预措施稀少，且效果维持时间短，尚未在现有医疗体系中实施。有必要整合不同疾病状况下的当前最佳证据、患者体验和临床专业知识，以开发出可行且有效的IBD相关疲劳管理干预措施。本研究通过修改一项针对多发性硬化症患者的现有干预措施，旨在评估认知行为疗法（CBT）干预对IBD患者疲劳管理的可行性及初步疗效评估。
本研究将是一项双臂试点随机对照试验。患者将从一家门诊IBD诊所招募，并随机分为两组：第1组（用于疲劳管理的CBT手册，为期八周，与治疗师进行一次60分钟的面谈和七次30分钟的电话/网络电话面谈）；或第2组（无需治疗师帮助即可使用的疲劳信息表）。在随机分组后的基线、3个月、6个月和12个月时收集自我报告的IBD相关疲劳（炎症性肠病疲劳量表）、IBD生活质量（英国炎症性肠病问卷）以及自我报告的疾病活动情况。仅在随机分组后3个月收集疾病认知、日间嗜睡、焦虑和抑郁等解释变量。临床和社会人口学数据将从患者病历中获取。一项嵌套的定性研究将评估患者和治疗师的体验，以及医疗保健专业人员对该干预措施的看法。
本研究将为CBT干预对IBD患者疲劳管理的可行性及初步疗效评估提供证据。该研究的定量和定性结果将有助于开展和实施一项大规模随机对照试验，以评估CBT干预对IBD相关疲劳的疗效。
ISRCTN注册库，ISRCTN17917944。于2016年9月2日注册。
