Department of Psychosomatic Medicine, Division of Internal Medicine, University Hospital Basel, Hebelstrasse 2, Basel, Switzerland.
Neurology. 2010 Sep 28;75(13):1141-9. doi: 10.1212/WNL.0b013e3181f4d80d.
Health-related quality of life (HRQOL) is often much reduced among individuals with multiple sclerosis (MS), and incidences of depression, fatigue, and anxiety are high. We examined effects of a mindfulness-based intervention (MBI) compared to usual care (UC) upon HRQOL, depression, and fatigue among adults with relapsing-remitting or secondary progressive MS.
A total of 150 patients were randomly assigned to the intervention (n = 76) or to UC (n = 74). MBI consisted of a structured 8-week program of mindfulness training. Assessments were made at baseline, postintervention, and 6 months follow-up. Primary outcomes included disease-specific and disease-aspecific HRQOL, depression, and fatigue. Anxiety, personal goal attainment, and adherence to homework were secondary outcomes.
Attrition was low in the intervention group (5%) and attendance rate high (92%). Employing intention-to-treat analysis, MBI, compared with UC, improved nonphysical dimensions of primary outcomes at postintervention and follow-up (p < 0.002); effect sizes, 0.4-0.9 posttreatment and 0.3-0.5 at follow-up. When analyses were repeated among subgroups with clinically relevant levels of preintervention depression, fatigue, or anxiety, postintervention and follow-up effects remained significant and effect sizes were larger than for the total sample.
In addition to evidence of improved HRQOL and well-being, these findings demonstrate broad feasibility and acceptance of, as well as satisfaction and adherence with, a program of mindfulness training for patients with MS. The results may also have treatment implications for other chronic disorders that diminish HRQOL.
This trial provides Class III evidence that MBI compared with UC improved HRQOL, fatigue, and depression up to 6 months postintervention.
多发性硬化症(MS)患者的健康相关生活质量(HRQOL)通常会大幅降低,且抑郁、疲劳和焦虑的发病率较高。我们研究了正念为基础的干预(MBI)与常规护理(UC)对复发缓解型或继发进展型 MS 成人的 HRQOL、抑郁和疲劳的影响。
共有 150 名患者被随机分配到干预组(n=76)或 UC 组(n=74)。MBI 包括为期 8 周的正念训练结构化方案。在基线、干预后和 6 个月随访时进行评估。主要结局包括疾病特异性和疾病非特异性 HRQOL、抑郁和疲劳。焦虑、个人目标达成和家庭作业依从性为次要结局。
干预组的脱落率较低(5%),出席率较高(92%)。采用意向治疗分析,与 UC 相比,MBI 在干预后和随访时改善了主要结局的非身体维度(p<0.002);治疗后效应大小为 0.4-0.9,随访时为 0.3-0.5。当在亚组中进行分析,这些亚组具有相关的干预前抑郁、疲劳或焦虑水平时,干预后和随访后的效果仍然显著,且效应大小大于总样本。
除了改善 HRQOL 和幸福感的证据外,这些发现还表明,对于 MS 患者,正念训练方案具有广泛的可行性和可接受性,以及对其的满意度和依从性。这些结果可能对其他降低 HRQOL 的慢性疾病也具有治疗意义。
本试验提供了 III 级证据,与 UC 相比,MBI 可改善 HRQOL、疲劳和抑郁,干预后 6 个月时效果仍然显著。