Expert Centre for Chronic Fatigue, Department of Medical Psychology, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, Netherlands; Department of Medical Psychology, Radboud University Medical Centre, Nijmegen, Netherlands.
Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, Netherlands.
Lancet Diabetes Endocrinol. 2017 Jun;5(6):448-456. doi: 10.1016/S2213-8587(17)30098-0. Epub 2017 Apr 24.
Fatigue in type 1 diabetes is prevalent and persistent, but so far, no evidence-based treatments are available. We aimed to investigate the efficacy of cognitive behavioural therapy (CBT) in reducing fatigue severity in patients with type 1 diabetes.
We did a multicentre randomised controlled trial at one university medical centre and four large teaching hospitals in the Netherlands. Eligible patients were aged 18-70 years and had type 1 diabetes for at least 1 year and chronic fatigue for at least 6 months. We randomly assigned patients (1:1) to CBT or waiting list using computer-generated blocked randomisation, stratified by type of enrolment. The CBT intervention (Dia-Fit) was given for 5 months in blended form, consisting of face-to-face and web-based sessions. The primary outcome was fatigue severity assessed 5 months after randomisation, directly after the intervention or waiting list period, with the Checklist Individual Strength fatigue severity subscale. Secondary outcomes were functional impairment (assessed with the total score of the Sickness Impact Profile-8), glycaemic control (HbA), and glucose variability. Analyses were done by intention to treat. This trial is registered with the Nederlands Trial Register, number NTR4312.
Between Feb 6, 2014, and March 24, 2016, we randomly assigned 120 eligible patients to either CBT (n=60) or waiting list (n=60), all of whom were included in the intention-to-treat analyses. Compared with patients in the waiting list group, those in the CBT group had significantly lower fatigue severity scores (mean difference 13·8, 95% CI 10·0-17·5; p<0·0001) and significantly lower scores for functional impairment (mean difference 513, 95% CI 340-686; p<0·0001) after 5 months. HbA and glucose variability did not change after treatment and there was no difference between groups. Five patients in the CBT group and seven in the waiting list group reported adverse events; none were deemed to be related to the study intervention.
Although our findings need to be confirmed in larger and longer-term studies, they suggest that CBT can effectively reduce fatigue severity and functional impairment in type 1 diabetes.
Dutch Diabetes Research Foundation (Diabetes Fonds).
1 型糖尿病患者普遍存在且持续存在疲劳，但迄今为止，尚无循证治疗方法。我们旨在研究认知行为疗法（CBT）在减轻 1 型糖尿病患者疲劳严重程度方面的疗效。
我们在荷兰的一家大学医学中心和四家大型教学医院进行了一项多中心随机对照试验。合格的患者年龄在 18-70 岁之间，患有 1 型糖尿病至少 1 年，慢性疲劳至少 6 个月。我们使用计算机生成的分组随机化将患者（1：1）随机分配到 CBT 或候补名单，按招募类型分层。CBT 干预（Dia-Fit）以混合形式进行，包括面对面和基于网络的课程，为期 5 个月。主要结局是在随机分组后 5 个月，直接在干预或候补名单期间，使用个体力量疲劳严重程度检查表评估疲劳严重程度。次要结局是功能障碍（使用 Sickness Impact Profile-8 的总评分评估）、血糖控制（HbA）和葡萄糖变异性。分析按意向治疗进行。该试验在荷兰临床试验注册中心注册，编号 NTR4312。
2014 年 2 月 6 日至 2016 年 3 月 24 日，我们随机将 120 名符合条件的患者分配到 CBT（n=60）或候补名单（n=60），所有患者均纳入意向治疗分析。与候补名单组的患者相比，CBT 组的疲劳严重程度评分明显更低（平均差异 13.8，95%CI 10.0-17.5；p<0.0001），功能障碍评分也明显更低（平均差异 513，95%CI 340-686；p<0.0001），差异均有统计学意义。治疗后 HbA 和葡萄糖变异性均无变化，且两组间无差异。CBT 组有 5 例患者和候补名单组有 7 例患者报告了不良事件，但均认为与研究干预无关。
尽管我们的研究结果需要在更大规模和更长时间的研究中得到证实，但它们表明 CBT 可以有效减轻 1 型糖尿病患者的疲劳严重程度和功能障碍。
荷兰糖尿病研究基金会（Diabetes Fonds）。
