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)
العنوان: | 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) |
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المؤلفون: | Rona Moss-Morris, Raffaele Tuccillo, Nicolás Fayed, Antoni Serrano-Blanco, Adrián Pérez-Aranda, Matthew A. Howard, Albert Feliu-Soler, Marta Puebla-Guedea, Antoni Rozadilla-Sacanell, Juan V. Luciano, Francesco D'Amico, Xavier Borrás, María Teresa Peñarrubia-María, Carles Soriano-Mas |
المصدر: | Dipòsit Digital de la UB Universidad de Barcelona Feliu-Soler, A, Borràs, X, Peñarrubia-María, M T, Rozadilla-Sacanell, A, D'Amico, F, Moss-Morris, R, Howard, M A, Fayed, N, Soriano-Mas, C, Puebla-Guedea, M, Serrano-Blanco, A, Pérez-Aranda, A, Tuccillo, R & Luciano, J V 2016, ' 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, vol. 16, no. 1, 81 . https://doi.org/10.1186/s12906-016-1068-2Test Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona Recercat. Dipósit de la Recerca de Catalunya instname BMC Complementary and Alternative Medicine |
بيانات النشر: | BioMed Central, 2016. |
سنة النشر: | 2016 |
مصطلحات موضوعية: | Male, Research design, RZ Other systems of medicine, Mindfulness, Fibromyalgia, Reducció de l'estrès basada en Mindfulness, Cost-Benefit Analysis, medicine.medical_treatment, Psicoeducació, Body awareness, law.invention, Study Protocol, 0302 clinical medicine, Randomized controlled trial, law, Medicine, Mindfulness-based stress reduction, 030212 general & internal medicine, Cost-utility, Brain, Citocinas, General Medicine, Middle Aged, Distress, Meditation, Treatment Outcome, Research Design, Citocines, Mindfulness (Psychology), Mindfulness-Based Stress Reduction, Cytokines, Female, Adult, Estrès, medicine.medical_specialty, Adolescent, Neuroimaging, Psicoeducación, Stress, Young Adult, 03 medical and health sciences, Patient Education as Topic, Psychoeducation, Humans, Psychiatry, Neuroimagen, Neuroimatge, Aged, Estrés, Inflammation, Fibromiàlgia, business.industry, medicine.disease, Fibromialgia, RM Therapeutics. Pharmacology, Psychotherapy, Cost-utilitat, Complementary and alternative medicine, Physical therapy, Coste-utilidad, Reducción del estrés basada en Mindfulness, Atenció plena, business, Stress, Psychological, 030217 neurology & neurosurgery |
الوصف: | 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. 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 Deu 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). 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. NCT02561416 . Registered 23 September 2015. |
وصف الملف: | application/pdf |
الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a8bf1df270253473868eef90b7ec5474Test http://hdl.handle.net/2445/126878Test |
حقوق: | OPEN |
رقم الانضمام: | edsair.doi.dedup.....a8bf1df270253473868eef90b7ec5474 |
قاعدة البيانات: | OpenAIRE |
الوصف غير متاح. |