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Cost-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)
Feliu Soler, Albert (Parc Sanitari Sant Joan de Déu)
Borràs i Hernández, Francesc Xavier (Universitat Autònoma de Barcelona. Departament de Psicologia Bàsica, Evolutiva i de l'Educació)
Peñarrubia, María T. (Institut Català de la Salut)
Rozadilla-Sacanell, Antoni (Parc Sanitari Sant Joan de Déu)
D'Amico, Francesco (London School of Economics and Political Science)
Moss-Morris, Rona (King's College London. Department of Psychology)
Howard, Matthew A. (King's College London. Department of Neuroimaging)
Fayed, Nicolás (Hospital Quironsalud Zaragoza)
Soriano Mas, Carles (Universitat Autònoma de Barcelona. Departament de Psicobiologia i Metodologia de les Ciències de la Salut)
Puebla-Guedea, Marta (RedIAPP (Red de Investigación en Actividades Preventivas y Promoción de la Salud))
Serrano-Blanco, Antoni (Parc Sanitari Sant Joan de Déu)
Pérez-Aranda, Adrián (Parc Sanitari Sant Joan de Déu)
Tuccillo, Raffaele (Institut d'Investigació Biomèdica Sant Pau)
Luciano, Juan V. (Parc Sanitari Sant Joan de Déu)
Universitat Autònoma de Barcelona

Date: 2016
Abstract: Background: 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.
Rights: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. Creative Commons
Language: Anglès
Document: article ; recerca ; publishedVersion
Subject: Fibromyalgia ; Mindfulness-Based Stress Reduction ; Psychoeducation ; Neuroimaging ; Cytokines ; Cost-utility
Published in: BMC complementary and alternative medicine, Vol. 16, N. 81 (February 2016) , p. 1-16, ISSN 1472-6882

DOI: 10.1186/s12906-016-1068-2
PMID: 26921267

16 p, 907.2 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (scientific output) > Health sciences and biosciences > Institut d'Investigació Biomèdica Sant Pau
Research literature > UAB research groups literature > Research Centres and Groups (scientific output) > Health sciences and biosciences > GIES (Grup de Recerca en Estrès i Salut)
Articles > Research articles
Articles > Published articles

 Record created 2017-03-08, last modified 2020-11-09

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