title: 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).
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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT02561416 . Registered 23 September 2015.
authors.affiliation: Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, C/Dr. Antoni Pujadas 42, 08830, Sant Boi de Llobregat, Barcelona, Spain. a.feliu@pssjd.org.|Centre for Biomedical Research in Mental Health, CIBERSAM, Madrid, Spain. a.feliu@pssjd.org.
authors.forename: Albert
authors.initials: A
authors.lastname: Feliu-Soler
authors.affiliation: Stress and Health Research Group, Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain. xavier.borras@uab.cat.
authors.forename: Xavier
authors.initials: X
authors.lastname: Borràs
authors.affiliation: Primary Health Centre Bartomeu Fabrés Anglada, DAP Delta Llobregat, Unitat Docent Costa de Ponent, Institut Català de la Salut, Gavà, Spain. 32829mpm@comb.cat.|Primary Care Prevention and Health Promotion Research Network (RedIAPP), Madrid, Spain. 32829mpm@comb.cat.
authors.forename: María T
authors.initials: MT
authors.lastname: Peñarrubia-María
authors.affiliation: Rheumatology Service, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain. antoni.rozadilla@pssjd.org.
authors.forename: Antoni
authors.initials: A
authors.lastname: Rozadilla-Sacanell
authors.affiliation: Personal Social Services Research Unit, London School of Economics and Political Science, London, UK. F.D'Amico@lse.ac.uk.
authors.forename: Francesco
authors.initials: F
authors.lastname: D'Amico
authors.affiliation: Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London, UK. rona.moss-morris@kcl.ac.uk.
authors.forename: Rona
authors.initials: R
authors.lastname: Moss-Morris
authors.affiliation: Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Matthew.Howard@kcl.ac.uk.
authors.forename: Matthew A
authors.initials: MA
authors.lastname: Howard
authors.affiliation: Magnetic Resonance Unit, Department of Radiology, Hospital Quironsalud Zaragoza, Zaragoza, Spain. nicola33fr@yahoo.es.
authors.forename: Nicolás
authors.initials: N
authors.lastname: Fayed
authors.affiliation: Centre for Biomedical Research in Mental Health, CIBERSAM, Madrid, Spain. csoriano@idibell.cat.|Department of Psychiatry, Bellvitge University Hospital, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain. csoriano@idibell.cat.|Department of Psychobiology and Methodology of Health Sciences, Universitat Autònoma de Barcelona, Barcelona, Spain. csoriano@idibell.cat.
authors.forename: Carles
authors.initials: C
authors.lastname: Soriano-Mas
authors.affiliation: Primary Care Prevention and Health Promotion Research Network (RedIAPP), Madrid, Spain. martapueblag@gmail.com.|Aragon Institute of Health Sciences (I+CS), Zaragoza, Spain. martapueblag@gmail.com.
authors.forename: Marta
authors.initials: M
authors.lastname: Puebla-Guedea
authors.affiliation: Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, C/Dr. Antoni Pujadas 42, 08830, Sant Boi de Llobregat, Barcelona, Spain. aserrano@pssjd.org.|Primary Care Prevention and Health Promotion Research Network (RedIAPP), Madrid, Spain. aserrano@pssjd.org.
authors.forename: Antoni
authors.initials: A
authors.lastname: Serrano-Blanco
authors.affiliation: Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, C/Dr. Antoni Pujadas 42, 08830, Sant Boi de Llobregat, Barcelona, Spain. adrian.peara@gmail.com.
authors.forename: Adrián
authors.initials: A
authors.lastname: Pérez-Aranda
authors.affiliation: Hospital de Sant Pau, Barcelona, Spain. raffaele_tuccillo@hotmail.it.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Tuccillo
authors.affiliation: Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, C/Dr. Antoni Pujadas 42, 08830, Sant Boi de Llobregat, Barcelona, Spain. jvluciano@pssjd.org.|Primary Care Prevention and Health Promotion Research Network (RedIAPP), Madrid, Spain. jvluciano@pssjd.org.
authors.forename: Juan V
authors.initials: JV
authors.lastname: Luciano
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001921:Brain / Q000378:metabolism / Q000502:physiology; D003362:Cost-Benefit Analysis; D016207:Cytokines / Q000378:metabolism; D005260:Female; D005356:Fibromyalgia / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D007249:Inflammation / Q000378:metabolism; D008297:Male; D019122:Meditation; D008875:Middle Aged; D064866:Mindfulness; D010353:Patient Education as Topic; D011613:Psychotherapy; D012107:Research Design; D013315:Stress, Psychological / Q000628:therapy; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016207:Cytokines