000148136 001__ 148136 000148136 005__ 20250114155432.0 000148136 0247_ $$2doi$$a10.1186/s12906-016-1068-2 000148136 0248_ $$2sideral$$a141566 000148136 037__ $$aART-2016-141566 000148136 041__ $$aeng 000148136 100__ $$aFeliu Soler, A. 000148136 245__ $$aCost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) versus a psychoeducational programme (FibroQoL) for fibromyalgia: a 12-month randomised controlled trial (EUDAIMON study). 000148136 260__ $$c2016 000148136 5060_ $$aAccess copy available to the general public$$fUnrestricted 000148136 5203_ $$aBackground The EUDAIMON study focuses on fibromyalgia syndrome (FMS), a prevalent chronic condition characterized by pain, fatigue, cognitive problems and distress. According to recent reviews and meta-analyses, Mindfulness-Based Stress Reduction (MBSR) is a promising therapeutic approach for patients with FMS. The measurement of biomarkers as part of the analysis of MBSR effects would help to identify the neurobiological underpinnings of MBSR and increase our knowledge of FMS pathophysiology. The main objectives of this 12-month RCT are: firstly, to examine the effectiveness and cost-utility for FMS patients of MBSR as an add-on to treatment as usual (TAU) versus TAU + the psychoeducational programme FibroQoL, and versus TAU only; secondly, to examine pre-post differences in brain structure and function, as well as levels of specific inflammatory markers in the three study arms and; thirdly, to analyse the role of some psychological variables as mediators of 12-month clinical outcomes. Methods Effectiveness, cost-utility, and neurobiological analyses performed alongside a 12-month RCT. The participants will be 180 adult patients with FMS recruited at the Sant Joan de Déu hospital (St. Boi de Llobregat, Spain), randomly allocated to one of the three study arms: TAU + MBSR vs. TAU + FibroQol vs. TAU. A comprehensive assessment to collect functional, quality of life, distress, costs, and psychological variables will be conducted pre-, post-intervention, and at 12-month post-intervention. Fifty per cent of study participants will be evaluated at pre- and post-treatment using Voxel-Based Morphometry, Diffusion Tensor Imaging, pseudo-continuous Arterial Spin Labeling, and resting state fMRI. A cytokine multiplex kit of high-sensitivity will be applied (cytokines IL-6, IL-8, IL-10 + high-sensitivity CRP test). Discussion The findings obtained from this RCT will indicate whether MBSR is potentially cost-effective for FMS and contribute to knowledge of any brain and inflammatory changes associated with MBSR in FMS patients. Specifically, we will determine whether there are morphometric and functional changes associated with participation in MBSR in brain regions related to meta-awareness, body awareness, memory consolidation-reconsolidation, emotion regulation and in networks postulated to underpin the sensory-discriminative, cognitive-evaluative and affective-motivational aspects of the pain experience. 000148136 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII/CP14-00087$$9info:eu-repo/grantAgreement/ES/ISCIII/PI15-00383 000148136 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000148136 590__ $$a2.288$$b2016 000148136 591__ $$aINTEGRATIVE & COMPLEMENTARY MEDICINE$$b6 / 25 = 0.24$$c2016$$dQ1$$eT1 000148136 592__ $$a0.856$$b2016 000148136 593__ $$aComplementary and Alternative Medicine$$c2016$$dQ1 000148136 593__ $$aMedicine (miscellaneous)$$c2016$$dQ2 000148136 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000148136 700__ $$aBorràs, X. 000148136 700__ $$aPeñarrubia María, M. T. 000148136 700__ $$aRozadilla Sacanell, A. 000148136 700__ $$aD'Amico, F. 000148136 700__ $$aMoss Morris, R. 000148136 700__ $$aHoward, M. A. 000148136 700__ $$aFayed, N. 000148136 700__ $$aSoriano Mas, C. 000148136 700__ $$0(orcid)0000-0002-8862-7240$$aPuebla Guedea, M. 000148136 700__ $$aSerrano Blanco, A. 000148136 700__ $$aPérez Aranda, A. 000148136 700__ $$aTuccillo, R. 000148136 700__ $$aLuciano, J.V.. 000148136 773__ $$g16, 81 (2016), 16$$pBMC COMPLEMENTARY AND ALTERNATIVE MEDICINE$$tBMC COMPLEMENTARY AND ALTERNATIVE MEDICINE$$x1472-6882 000148136 8564_ $$s928993$$uhttps://zaguan.unizar.es/record/148136/files/texto_completo.pdf$$yVersión publicada 000148136 8564_ $$s2144329$$uhttps://zaguan.unizar.es/record/148136/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000148136 909CO $$ooai:zaguan.unizar.es:148136$$particulos$$pdriver 000148136 951__ $$a2025-01-13-14:28:27 000148136 980__ $$aARTICLE