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基于互联网的认知行为治疗对青少年慢性疲劳综合征的疗效(FITNET):一项随机对照试验。

Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial.

机构信息

Department of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Netherlands.

出版信息

Lancet. 2012 Apr 14;379(9824):1412-8. doi: 10.1016/S0140-6736(12)60025-7. Epub 2012 Mar 3.

Abstract

BACKGROUND

Chronic fatigue syndrome is characterised by persistent fatigue and severe disability. Cognitive behavioural therapy seems to be a promising treatment, but its availability is restricted. We developed Fatigue In Teenagers on the interNET (FITNET), the first dedicated internet-based therapeutic program for adolescents with this disorder, and compared its effectiveness with that of usual care.

METHODS

Adolescents aged 12-18 years with chronic fatigue syndrome were assigned to FITNET or usual care in a 1:1 ratio at one tertiary treatment centre in the Netherlands by use of a computer-generated blocked randomisation allocation schedule. The study was open label. Primary outcomes were school attendance, fatigue severity, and physical functioning, and were assessed at 6 months with computerised questionnaires. Analysis was by intention to treat. Thereafter, all patients were offered FITNET if needed. This trial is registered, number ISRCTN59878666.

FINDINGS

68 of 135 adolescents were assigned to FITNET and 67 to usual care, and 67 and 64, respectively, were analysed. FITNET was significantly more effective than was usual care for all dichotomised primary outcomes at 6 months-full school attendance (50 [75%] vs 10 [16%], relative risk 4·8, 95% CI 2·7-8·9; p<0·0001), absence of severe fatigue (57 [85%] vs 17 [27%], 3·2, 2·1-4·9; p<0·0001), and normal physical functioning (52 [78%] vs 13 [20%], 3·8, 2·3-6·3; p<0·0001). No serious adverse events were reported.

INTERPRETATION

FITNET offers a readily accessible and highly effective treatment for adolescents with chronic fatigue syndrome. The results of this study justify implementation on a broader scale.

FUNDING

Netherlands Organisation for Health Research and Development.

摘要

背景

慢性疲劳综合征的特点是持续疲劳和严重残疾。认知行为疗法似乎是一种很有前途的治疗方法,但可用性有限。我们开发了青少年网络疲劳治疗计划(FITNET),这是第一个专门为患有这种疾病的青少年提供的基于互联网的治疗计划,并将其与常规护理进行了比较。

方法

在荷兰的一家三级治疗中心,将年龄在 12-18 岁之间患有慢性疲劳综合征的青少年以 1:1 的比例随机分配到 FITNET 或常规护理组,采用计算机生成的分组随机分配方案。研究是开放标签的。主要结局是在校出勤率、疲劳严重程度和身体功能,在 6 个月时通过计算机化问卷进行评估。分析是基于意向治疗。此后,如果需要,所有患者都可以获得 FITNET。这项试验已注册,编号 ISRCTN59878666。

结果

共有 135 名青少年中有 68 名被分配到 FITNET,67 名被分配到常规护理,分别有 67 名和 64 名被纳入分析。6 个月时,FITNET 在所有二分法主要结局上均显著优于常规护理:全勤(50[75%]vs10[16%],相对风险 4.8,95%CI2.7-8.9;p<0.0001)、无严重疲劳(57[85%]vs17[27%],3.2,2.1-4.9;p<0.0001)和正常身体功能(52[78%]vs13[20%],3.8,2.3-6.3;p<0.0001)。未报告严重不良事件。

解释

FITNET 为患有慢性疲劳综合征的青少年提供了一种易于获得且非常有效的治疗方法。这项研究的结果证明了在更广泛的范围内实施的合理性。

资助

荷兰健康研究与发展组织。

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