Objective: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Classification of evidence: This trial provides Class III evidence that MBI compared with UC improved HRQOL, fatigue, and depression up to 6 months postintervention.
Keywords: ANCOVA = analysis of covariance; CES-D = Center for Epidemiologic Studies Depression Scale; CI = confidence interval; EDSS = Expanded Disability Status Scale; ES = effect size; HAQUAMS = Hamburg Quality of Life Questionnaire in Multiple Sclerosis; HRQOL = health-related quality of life; MBI = mindfulness-based intervention; MFIS = Modified Fatigue Impact Scale; MS = multiple sclerosis; NNT = number needed to treat; PQOLC = Profile of Health-Related Quality of Life in Chronic Disorders; PRO = patient-reported outcome; STAI = Spielberger Trait Anxiety Inventory; UC = usual care.