University of Western Ontario (Western), Department of Clinical Neurological Sciences, London Health Sciences Center, London, ON Canada; Parkwood Institute, Department of Cognitive Neurology London Health Sciences Center; Lawson Research Institute London, ON Canada; Lawson Health Research Institute, London, ON, Canada.
University of Western Ontario (Western), Department of Clinical Neurological Sciences, London Health Sciences Center, London, ON Canada; Lawson Health Research Institute, London, ON, Canada.
Mult Scler Relat Disord. 2021 Jul;52:103016. doi: 10.1016/j.msard.2021.103016. Epub 2021 May 8.
Relapsing MS (RMS) is a lifelong disease without a cure, usually diagnosed between 20-40 years of age. Being newly diagnosed with RMS is a highly stressful event due to the unpredictable disease course after diagnosis. Thus, it is imperative that persons with MS have the skills and support to cope with the negative physical and emotional effects of the disease. The objective of this study was to assess whether a mindfulness-based intervention (MBI) would improve coping skills and thus lessen the negative consequences of stress due to being newly diagnosed with RMS.
This was a single-blind (assessor), randomized, prospective study of a 10-week MBI vs. usual standard of care in persons newly diagnosed (within 1 year) with RMS, recruited from one tertiary care MS clinic in London (ON), Canada. The MBI was administered in group format with a trained MBI facilitator. Primary outcomes included the Brief COPE measure and the Hospital Anxiety and Depression Scale (HADS) subscales. Secondary outcomes included measures of perceived stress, cognitive function, fatigue, and quality of life. Exploratory (tertiary) outcomes included serum markers of inflammation and stress. Subjects were assessed at baseline, post intervention (or equivalent) and 6 months later. A repeated measures multivariate analysis of covariance (MANCOVA) was used, with baseline scores employed as covariates and the test scores, to compare longitudinal changes, immediately after the MBI sessions and 6 months later.
Twenty-five subjects were recruited (16 MBI, 9 controls) for two (Fall and Spring) MBI interventions over 1.5 years. All controls completed the study, while 4 MBI participants did not, leaving 21 subjects in the analysis. Most were women (17, 81%), with a mean age of 37.1 ± 9.4 years. Two thirds had already started a DMT at the time of consent; the median EDSS was 2.0 (0.0-4.0). The groups were well matched on baseline characteristics, with the exception of months since diagnosis (MBI 6.4 ± 6.5 vs. control 3.6 ± 2.8, p=0.023). All controls completed the study, while 4 MBI participants did not. The MBI group improved significantly on the COPE measure when compared to the control group (p=0.024) pre and post intervention; the MBI group also improved significantly on the HADS depression subscale (p=0.007). There was no significant difference over time on the HADS anxiety subscale (p=0.179). The effect size on COPE was 0.56 and 0.40 on HADS-D. On the secondary outcomes, there was a significant improvement on the Perceived Stress Scale (p=0.015). The exploratory outcomes were not significantly different. None of the outcomes were significant at the six-month follow-up.
This pilot study demonstrates that an MBI may improve coping, depression and perceived stress in newly diagnosed (within one year) persons with RMS in the short term. Future research to confirm these results, as well as further investigate measures to extend the benefit beyond the immediate intervention.
复发性多发性硬化症（RMS）是一种无法治愈的终身疾病，通常在 20-40 岁之间被诊断出来。由于在诊断后疾病的发展不可预测，因此新诊断出 RMS 是一个高度紧张的事件。因此，多发性硬化症患者必须具备应对疾病带来的身体和情绪负面影响的技能和支持。本研究的目的是评估一种基于正念的干预（MBI）是否会改善应对技能，从而减轻因新诊断出 RMS 而产生的压力的负面影响。
这是一项在伦敦（ON）加拿大一家三级护理多发性硬化症诊所招募的、为期 10 周的 MBI 与常规标准护理对比的、针对新诊断（1 年内）多发性硬化症患者的单盲（评估者）、随机、前瞻性研究。MBI 由经过培训的 MBI 促进者以小组形式进行。主要结局指标包括简要应对量表（Brief COPE）和医院焦虑抑郁量表（HADS）子量表。次要结局指标包括感知压力、认知功能、疲劳和生活质量的测量。探索性（三级）结局指标包括炎症和应激的血清标志物。在基线、干预后（或等效）和 6 个月后对受试者进行评估。采用重复测量多元方差分析（MANCOVA），以基线得分作为协变量，以测试得分进行比较，以比较立即进行 MBI 课程后和 6 个月后的纵向变化。
在 1.5 年内进行了两次（秋季和春季）MBI 干预，共招募了 25 名受试者（16 名 MBI，9 名对照组）。所有对照组均完成了研究，而 4 名 MBI 参与者未完成，因此分析中剩下 21 名受试者。大多数是女性（17 名，81%），平均年龄为 37.1 ± 9.4 岁。三分之二的患者在同意时已经开始使用 DMT；中位数 EDSS 为 2.0（0.0-4.0）。两组在基线特征上匹配良好，除了诊断后月份（MBI 6.4 ± 6.5 vs. 对照组 3.6 ± 2.8，p=0.023）外。所有对照组均完成了研究，而 4 名 MBI 参与者未完成。与对照组相比，MBI 组在应对量表上的得分显著提高（p=0.024），在干预前后；MBI 组在 HADS 抑郁子量表上的得分也显著提高（p=0.007）。HADS 焦虑子量表的时间差异无统计学意义（p=0.179）。COPE 的效应大小为 0.56，HADS-D 的效应大小为 0.40。在次要结局方面，感知压力量表（p=0.015）有显著改善。探索性结果没有显著差异。在 6 个月的随访中，没有任何结果具有统计学意义。
这项初步研究表明，在短期内，MBI 可能会改善新诊断（1 年内）多发性硬化症患者的应对方式、抑郁和感知压力。需要进一步的研究来证实这些结果，并进一步研究延长干预效果的措施。
