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, Xavier Borràs, M. Peñarrubia-María, A. Rozadilla-Sacanell, Francesco d’Amico, R. Moss‐Morris, M. Howard, Nicolás Fayed, C. Soriano-Mas, M. Puebla-Guedea, Antoni Serrano-Blanco, Adrián Pérez-aranda, R. Tuccillo, Juan V Luciano
BMC Complementary and Alternative Medicine February 27, 2016 DOI: 10.1186/s12906-016-1068-2 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 180 |
| Population | Adult patients with fibromyalgia syndrome |
| Intervention | Mindfulness-Based Stress Reduction |
| Duration | 12-month intervention and follow-up |
| Topics | Meditation |
| Key findings | The trial will determine whether MBSR as an add-on to treatment as usual is effective and cost-effective for FMS patients compared to FibroQoL or usual care alone. |
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.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 8
- Does practice make perfect? Functional connectivity of the salience network and somatosensory network predicts response to mind-body treatments for fibromyalgia. Frontiers in Pain Research 2024
- Mind-body practices, interoception and pain: a scoping review of behavioral and neural correlates. Annals of medicine 2023
- Differential Brain Perfusion Changes Following Two Mind-Body Interventions for Fibromyalgia Patients: an Arterial Spin Labelling fMRI Study. Mindfulness 2022
- Sleep and mindfulness meditation as they relate to false memory. Psychological Research June 2020
- A randomized controlled efficacy trial of Mindfulness-Based Stress Reduction compared to an active control group and usual care for fibromyalgia: the EUDAIMON study. Pain August 13, 2019
and 3 more in the library
Cites 16
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- Meditation experience is associated with differences in default mode network activity and connectivity Proceedings of the National Academy of Sciences November 23, 2011
- Standardised Mindfulness-Based Interventions in Healthcare: An Overview of Systematic Reviews and Meta-Analyses of RCTs PLoS One April 16, 2015
- Increased default mode network connectivity associated with meditation Neuroscience Letters October 28, 2010
- Fibromyalgia Impact and Mindfulness Characteristics in 4986 People with Fibromyalgia. Explore April 28, 2015
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