本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(24)00533-6

摘要内容如下：

背景

运动神经元病是一种进行性、致命性神经退行性疾病，目前尚无治愈方法。接纳与承诺疗法（ACT）是一种结合接纳、正念和行为改变技巧的心理疗法。我们的目的是评估ACT加常规护理与单独常规护理相比，在改善运动神经元病患者生活质量方面的有效性。

方法

我们在英国16个运动神经元病护理中心或诊所进行了一项平行、多中心、两组随机对照试验。符合条件的参与者年龄为18岁或以上，诊断为明确或实验室支持的可能、临床可能或可能的家族性或散发性肌萎缩侧索硬化症；进行性肌萎缩；或原发性侧索硬化；符合世界神经病学联合会的El Escorial诊断标准。参与者被随机分配（1:1）接受最多8次适合运动神经元病患者的ACT治疗，加上常规护理或通过网络系统单独进行常规护理，按地点分层。参与者在随机分组后6个月和9个月随访。结果评估者和试验统计员对治疗分配不知情。主要结果是随机分组后6个月使用麦吉尔生活质量问卷修订版（MQOL-R）的生活质量。主要分析是多层次模型和根据现有数据对参与者的治疗意向进行修正。该试验已在ISRCTN注册中心（ISRCTN12655391）预先注册。

调查结果

在2019年9月18日至2022年8月31日期间，435名运动神经元疾病患者参与了该研究，其中206人（47%）被评估为合格，191人被招募。97名（51%）参与者被随机分配到ACT+常规护理，94名（49%）参与者被分配到单独的常规护理。191名参与者中有80名（42%）为女性，111名（58%）为男性，平均年龄为63.1岁（SD 11.0）。155名（81%）参与者在随机分组后6个月有主要结果数据。在控制基线评分、年龄、性别和治疗师聚类后，ACT加常规护理在6个月时的生活质量优于单独常规护理（MQOL-R的校正平均差异为0.66[95%CI 0.22-1.10]；d=0.46[0.16-0.77]；P=0.0031）。中等效应大小具有临床意义。报告了75例不良事件，其中38例为严重不良事件，但未发现与干预相关的不良事件。

解释

ACT加常规护理在临床上对维持或改善运动神经元病患者的生活质量有效。随着证实这些发现的进一步证据的出现，卫生保健提供者应考虑如何在运动神经元病临床服务中提供适合运动神经元病患者特殊需求的青蒿素综合疗法。

英文原文如下：

Abstracts

BACKGROUND  Motor neuron disease is a progressive, fatal neurodegenerative disease for which there is no cure. Acceptance and Commitment Therapy (ACT) is a psychological therapy incorporating acceptance, mindfulness, and behaviour change techniques. We aimed to evaluate the effectiveness of ACT plus usual care, compared with usual care alone, for improving quality of life in people with motor neuron disease.

METHODS  We conducted a parallel, multicentre, two-arm randomised controlled trial in 16 UK motor neuron disease care centres or clinics. Eligible participants were aged 18 years or older with a diagnosis of definite or laboratory-supported probable, clinically probable, or possible familial or sporadic amyotrophic lateral sclerosis; progressive muscular atrophy; or primary lateral sclerosis; which met the World Federation of Neurology's El Escorial diagnostic criteria. Participants were randomly assigned (1:1) to receive up to eight sessions of ACT adapted for people with motor neuron disease plus usual care or usual care alone by a web-based system, stratified by site. Participants were followed up at 6 months and 9 months post-randomisation. Outcome assessors and trial statisticians were masked to treatment allocation. The primary outcome was quality of life using the McGill Quality of Life Questionnaire-Revised (MQOL-R) at 6 months post-randomisation. Primary analyses were multi-level modelling and modified intention to treat among participants with available data. This trial was pre-registered with the ISRCTN Registry (ISRCTN12655391).

FINDINGS  Between Sept 18, 2019, and Aug 31, 2022, 435 people with motor neuron disease were approached for the study, of whom 206 (47%) were assessed for eligibility, and 191 were recruited. 97 (51%) participants were randomly assigned to ACT plus usual care and 94 (49%) were assigned to usual care alone. 80 (42%) of 191 participants were female and 111 (58%) were male, and the mean age was 63·1 years (SD 11·0). 155 (81%) participants had primary outcome data at 6 months post-randomisation. After controlling for baseline scores, age, sex, and therapist clustering, ACT plus usual care was superior to usual care alone for quality of life at 6 months (adjusted mean difference on the MQOL-R of 0·66 [95% CI 0·22-1·10]; d=0·46 [0·16-0·77]; p=0·0031). Moderate effect sizes were clinically meaningful. 75 adverse events were reported, 38 of which were serious, but no adverse events were deemed to be associated with the intervention.

INTERPRETATION  ACT plus usual care is clinically effective for maintaining or improving quality of life in people with motor neuron disease. As further evidence emerges confirming these findings, health-care providers should consider how access to ACT, adapted for the specific needs of people with motor neuron disease, could be provided within motor neuron disease clinical services.

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