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).

Albert Feliu-Soler,Carles Soriano-Mas,Marta Puebla-Guedea,Raffaele Tuccillo,Antoni Rozadilla-Sacanell,Rona Moss-Morris,Xavier Borràs,María T Peñarrubia-María,Antoni Serrano-Blanco,Adrián Pérez-Aranda,Juan V Luciano,Matthew A Howard,Nicolás Fayed,Francesco D’Amico

doi:10.1186/s12906-016-1068-2

Abstract

BackgroundThe 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.MethodsEffectiveness, 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).DiscussionThe 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.Trial registrationNCT02561416. Registered 23 September 2015.

Highlights

Introduction and general informationPatients’ Expectations.History and epidemiology of the syndrome
The findings obtained from this RCT will indicate whether Mindfulness-Based Stress Reduction (MBSR) is potentially cost-effective for fibromyalgia syndrome (FMS) and contribute to knowledge of any brain and inflammatory changes associated with MBSR in FMS patients
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

Summary

Methods

Study design This RCT protocol was developed following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [42] and was recorded in the ClinicalTrials.gov trial register in September 2015 (NCT02561416). CEQ Credibility/Expectancy Questionnaire, CSRI Client Service Receipt Inventory, EQ-5D-5L EuroQoL questionnaire, FFMQ Five Facet Mindfulness Questionnaire, FIQR Revised Fibromyalgia Impact Questionnaire, FSDC Fibromyalgia Survey Diagnostic Criteria, HADS Hospital Anxiety and Depression Scale, MISCI Multidimensional Inventory of Subjective Cognitive Impairment, MMSE Mini-Mental State Examination, PCS Pain Catastrophizing Scale, PGIC & PSIC Patient Global and Specific Impression of Change, respectively, PIPS Psychological Inflexibility in Pain Scale, PSS-10 Perceived Stress Scale, SCID-I Structured Clinical Interview for DSM Axis I Disorders, SCS-12 Self-Compassion Scale aSecondary outcome measures that considered process variables. – The Fibromyalgia Survey Diagnostic Criteria (FSDC) [59, 60] is a 6-item self-report questionnaire that registers the key symptoms of FMS according to the latest revision of the ACR It includes assessment through the Widespread Pain Index (WPI) identifying 19 body areas (jaws, shoulders, upper arms, lower arms, hips, upper legs, lower legs, neck, chest, upper back, lower back and abdomen) where pain or tenderness was felt during the previous 7 days (total score 0–19). Finalisation of patient recruitment: January 2017 Finalisation of patient monitoring period: April 2018 Publication of results: December 2018

Discussion

Background

Findings