Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis
Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis
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DOI：
10.1136/jnnp-2017-317463
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发表时间：
2018-09-01
影响因子：
11
通讯作者：
Gold, Stefan M.
中科院分区：
文献类型：
--
作者：
Poettgen, Jana;Moss-Morris, Rona;Gold, Stefan M.
目的疲劳是包括多发性硬化（MS）在内的许多慢性疾病的主要致残症状，但治疗方法有限。在这里，我们测试了自我指导，互动，在线疲劳管理计划（ELEVIDA）的有效性，该计划基于认知行为疗法（CBT）和相关心理治疗方法的原则方法通过德国MS协会的网站招募MS和自我报告疲劳的患者，并通过自动随机发生器分配（1：1，无阻断或分层）至12周在线干预（ELEVIDA，n=139，82%女性，平均年龄40.8，中位患者确定的疾病分级（PDDS）3.0）或等待列表对照组（n=136，79%女性，平均年龄41.9，中位PDDS 3.0）。主要结局是Chalder疲劳量表。在基线、第12周时评估结局结果与对照组相比，在第12周，ELEVIDA组的Chalder疲劳量表评分显著降低（主要终点，意向治疗分析：组间平均差异2.74分; 95% CI 1.16 - 4.32; p=0.0007;效应量d=0.53），效应持续到第24周（意向治疗分析：组间平均差异2.19分; 95% CI 0.57 - 3.82; p=0.0080）。结论我们的试验为自我指导，基于互联网的干预措施，以减少疲劳的MS。干预措施，如ELEVIDA可能是一个合适的低障碍，成本效益的治疗选择MS疲劳。
Objective Fatigue is a major disabling symptom in many chronic diseases including multiple sclerosis (MS), but treatment options are limited. Here, we tested the effectiveness of a self-guided, interactive, online fatigue management programme (ELEVIDA) based on principles of cognitive behavioural therapy (CBT) and related psychotherapeutic approaches (eg, mindfulness) for reducing fatigue in MS.Methods Patients with MS and self-reported fatigue were recruited via the website of the German MS Society and assigned via an automated randomisation generator (1: 1, no blocking or stratification) to a 12-week online intervention (ELEVIDA, n=139, 82% female, mean age 40.8, median patient determined disease steps (PDDS) 3.0) or a waitlist control group (n=136, 79% female, mean age 41.9, median PDDS 3.0). The primary outcome was the Chalder Fatigue Scale. Outcomes were assessed at baseline, at week 12 (postintervention) and at follow-up (week 24).Results Compared with the control group, significantly greater reductions in Chalder Fatigue Scale scores were seen in the ELEVIDA group at week 12 (primary endpoint, intention-to-treat analysis: between-group mean difference 2.74 points; 95% CI 1.16 to 4.32; p=0.0007; effect size d=0.53), with effects sustained at week 24 (intention-to-treat analysis: between-group mean difference 2.19 points; 95% CI 0.57 to 3.82; p=0.0080).Conclusions Our trial provides evidence for the effectiveness of a self-guided, internet-based intervention to reduce fatigue in MS. Interventions such as ELEVIDA may be a suitable low barrier, cost-effective treatment option for MS fatigue.