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Pain. 2019 Aug 13. doi: 10.1097/j.pain.0000000000001655. [Epub ahead of print]

A randomized controlled efficacy trial of mindfulness-based stress reduction compared with an active control group and usual care for fibromyalgia: the EUDAIMON study.

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Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.
Teaching, Research and Innovation Unit, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain.
Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain.
Department of Clinical Psychology and Psychobiology (Section Personality, Assessment and Psychological Treatments), University of Barcelona, Barcelona, Spain.
Dharamsala Institute of Mindfulness and Psychotherapy, Zaragoza, Spain.
Department of Psychiatry, Miguel Servet Hospital, Aragon Institute of Health Sciences (I+CS), Zaragoza, Spain.
Basic Psychology Unit, Autonomous University of Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.
Rheumatology Service, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain.
Primary Health Centre Bartomeu Fabrés Anglada, SAP Delta Llobregat, Unitat Docent Costa de Ponent, Institut Català de la Salut, Gavà, Spain.
Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública, CIBERESP, Madrid, Spain.
Fundació IDIAP Jordi Gol I Gurina, Barcelona, Spain.
Department of Psychology, Uppsala University, Uppsala, Sweden.


Fibromyalgia (FM) syndrome represents a great challenge for clinicians and researchers because the efficacy of currently available treatments is limited. This study examined the efficacy of mindfulness-based stress reduction (MBSR) for reducing functional impairment as well as the role of mindfulness-related constructs as mediators of treatment outcomes for people with FM. Two hundred twenty-five participants with FM were randomized into 3 study arms: MBSR plus treatment-as-usual (TAU), FibroQoL (multicomponent intervention for FM) plus TAU, and TAU alone. The primary endpoint was functional impact (measured with the Fibromyalgia Impact Questionnaire Revised), and secondary outcomes included "fibromyalginess," anxiety and depression, pain catastrophising, perceived stress, and cognitive dysfunction. The differences in outcomes between groups at post-treatment assessment (primary endpoint) and 12-month follow-up were analyzed using linear mixed-effects models and mediational models through path analyses. Mindfulness-based stress reduction was superior to TAU both at post-treatment (large effect sizes) and at follow-up (medium to large effect sizes), and MBSR was also superior to FibroQoL post-treatment (medium to large effect sizes), but in the long term, it was only modestly better (significant differences only in pain catastrophising and fibromyalginess). Immediately post-treatment, the number needed to treat for 20% improvement in MBSR vs TAU and FibroQoL was 4.0 (95% confidence interval [CI] = 2.1-6.5) and 5.0 (95% CI = 2.7-37.3). An unreliable number needed to treat value of 9 (not computable 95% CI) was found for FibroQoL vs TAU. Changes produced by MBSR in functional impact were mediated by psychological inflexibility and the mindfulness facet acting with awareness. These findings are discussed in relation to previous studies of psychological treatments for FM.

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