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)
Author
Feliu-Soler, Albert
Borràs, Xavier
Peñarrubia-María, María T.
Rozadilla-Sacanell, Antoni
D’Amico, Francesco
Moss-Morris, Rona
Howard, Matthew A.
Fayed, Nicolás
Soriano-Mas, Carles
Puebla-Guedea, Marta
Serrano-Blanco, Antoni
Pérez-Aranda, Adrián
Tuccillo, Raffaele
Luciano, Juan V.
Publication date
2016ISSN
2662-7671
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.
Document Type
Article
Document version
Published version
Language
English
Subject (CDU)
61 - Medical sciences
Keywords
Fibromiàlgia
Reducció de l'estrès basada en Mindfulness
Psicoeducació
Neuroimatge
Citocines
Cost-utilitat
Mindfulness
Estrès
Fibromialgia
Reducción del estrés basada en Mindfulness
Psicoeducación
Neuroimagen
Citocinas
Coste-utilidad
Mindfulness
Estrés
Fibromyalgia
Mindfulness-based stress reduction
Psychoeducation
Neuroimaging
Cytokines
Cost-utility
Mindfulness
Stress
Pages
16
Publisher
Springer Nature
Collection
16;
Is part of
BMC Complementary and Alternative Medicine
Citation
Feliu-Soler, Albert; Borràs, Xavier; Peñarrubia-María, María T. [et al.]. 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). BMC Complementary and Alternative Medicine, 2016, 16, 81. Disponible en: <https://bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-016-1068-2>. Fecha de acceso: 25 ene. 2022. DOI: 10.1186/s12906-016-1068-2
This item appears in the following Collection(s)
- Ciències de la Salut [725]
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