Journal
NEUROLOGY
Volume 75, Issue 13, Pages 1141-1149Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e3181f4d80d
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Funding
- Swiss National Science Foundation [3200B0-112604]
- Stanley T. Johnson Foundation
- Swiss Multiple Sclerosis Foundation
- Sanofi-Aventis
- Merck Serono
- Biogen-Dompe AG
- Swiss Cancer League
- Swiss MS Society
- Gianni Rubatto Foundation (Zurich)
- Acorda Therapeutics Inc.
- Actelion Pharmaceuticals Ltd.
- Abbott
- AstraZeneca
- Bayhill Therapeutics
- Bayer Schering Pharma
- Biogen Idec
- Boehringer Ingelheim
- Centocor Ortho Biotech Inc.
- Eisai Inc.
- Genzyme Corporation
- GlaxoSmithKline
- Immune Response Corporation
- MediciNova, Inc.
- Neurocrine Biosciences
- Novartis
- Roche
- Teva Pharmaceutical Industries Ltd.
- UCB
- Wyeth
- NIH [R01-MH059708, R01-HD043323, R34 MH078922]
- US Veterans Administration HSRD
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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. Neurology (R) 2010;75:1141-1149
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