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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Fibromyalgia (FM) is a prevalent, chronic, disabling, pain syndrome that implies high healthcare costs. Economic evaluations of potentially effective treatments for FM are needed. The aim of this study was to analyze the cost–utility of Mindfulness-Based Stress Reduction (MBSR) as an add-on to treatment-as-usual (TAU) for patients with FM compared to an adjuvant multicomponent intervention (“FibroQoL”) and to TAU. We performed an economic evaluation alongside a 12 month, randomized, controlled trial; data from 204 (68 per study arm) of the 225 patients (90.1%) were included in the cost–utility analyses, which were conducted both under the government and the public healthcare system perspectives. The main outcome measures were the EuroQol (EQ-5D-5L) for assessing Quality-Adjusted Life Years (QALYs) and improvements in health-related quality of life, and the Client Service Receipt Inventory (CSRI) for estimating direct and indirect costs. Incremental cost-effectiveness ratios (ICERs) were also calculated. Two sensitivity analyses (intention-to-treat, ITT, and per protocol, PPA) were conducted. The results indicated that MBSR achieved a significant reduction in costs compared to the other study arms (p < 0.05 in the completers sample), especially in terms of indirect costs and primary healthcare services. It also produced a significant incremental effect compared to TAU in the ITT sample (ΔQALYs = 0.053, p < 0.05, where QALYs represents quality-adjusted life years). Overall, our findings support the efficiency of MBSR over FibroQoL and TAU specifically within a Spanish public healthcare context.