Menting Juliane, Nikolaus Stephanie, Wiborg Jan-Frederic, Bazelmans Ellen, Goedendorp Martine M, van Bon Arianne C, van den Bergh Joop P, Mol Marc J T M, Tack Cees J, Knoop Hans
Expert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands.
Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.
Trials. 2015 Jun 6;16:262. doi: 10.1186/s13063-015-0764-4.
Fatigue is frequently reported by patients with type 1 diabetes mellitus. A recent study showed that 40 % of patients experienced severe fatigue that lasted for more than six months and was accompanied by substantial impairments in daily functioning. Currently, there is no effective treatment available for chronic fatigue in patients with type 1 diabetes. Cognitive behaviour therapy aimed at cognitions and behaviours that perpetuate fatigue is effective in reducing fatigue in other chronic diseases. Recent research showed that these cognitions and behaviours are also potential determinants of fatigue in type 1 diabetes. We designed Dia-Fit, a web-based cognitive behaviour therapy for severe and chronic fatigue in patients with type 1 diabetes. This patient-tailored intervention is aimed at reducing fatigue by changing cognitions and behaviours assumed to maintain fatigue. The efficacy of Dia-Fit will be investigated in this study.
METHODS/DESIGN: A randomised controlled trial will be conducted in 120 patients with type 1 diabetes who are chronically and severely fatigued. Patients will be randomised to a treatment or waiting list group. The treatment group will receive Dia-Fit, a blended care therapy consisting of up to eight internet modules and face-to-face sessions with a therapist during a five-month period. The treatment will be tailored to the fatigue-maintaining cognitions and behaviours that are relevant for the patient and are determined at baseline. The waiting list group will receive Dia-Fit after a waiting period of five months. The primary outcome measure is fatigue severity. Secondary outcome measures are functional impairment and glucose control determined by haemoglobin A1c and blood glucose variability.
To our knowledge, this is the first study investigating the efficacy of a cognitive behavioural intervention for chronic fatigue in patients with type 1 diabetes.
Dutch trial register NTR4312 (10 December 2013).
1型糖尿病患者经常报告有疲劳症状。最近一项研究表明，40%的患者经历了持续超过六个月的严重疲劳，并伴有日常功能的显著受损。目前，对于1型糖尿病患者的慢性疲劳尚无有效的治疗方法。针对使疲劳持续存在的认知和行为的认知行为疗法在减轻其他慢性疾病的疲劳方面是有效的。最近的研究表明，这些认知和行为也是1型糖尿病患者疲劳的潜在决定因素。我们设计了Dia-Fit，一种针对1型糖尿病患者严重和慢性疲劳的基于网络的认知行为疗法。这种针对患者的干预旨在通过改变假定维持疲劳的认知和行为来减轻疲劳。本研究将调查Dia-Fit的疗效。
方法/设计：将对120名患有慢性严重疲劳的1型糖尿病患者进行一项随机对照试验。患者将被随机分为治疗组或等待名单组。治疗组将接受Dia-Fit，这是一种混合护理疗法，包括多达八个网络模块以及在五个月期间与治疗师进行面对面的 sessions。治疗将根据与患者相关且在基线时确定的维持疲劳的认知和行为进行量身定制。等待名单组将在五个月的等待期后接受Dia-Fit。主要结局指标是疲劳严重程度。次要结局指标是功能损害以及通过糖化血红蛋白和血糖变异性确定的血糖控制情况。
据我们所知，这是第一项调查认知行为干预对1型糖尿病患者慢性疲劳疗效的研究。
荷兰试验注册NTR4312（2013年12月10日）。
