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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.
Previous studies have reported that life satisfaction (LS) is positively associated with time perspective (TP) and mindfulness and that mindfulness may provide a holistic TP that integrates and helps to balance different time frames. However, studies performed to date have only been conducted in Eastern and Central Europe. Given the important cultural differences in time management between these regions and Mediterranean countries, the purpose of the present study was to replicate those studies to assess the association between mindfulness, TP, and LS in a sample of young adults living in the province of Barcelona (Catalonia, Spain). A total of 377 undergraduate university students (65.25% women) were recruited and completed the Satisfaction with Life Scale (SWLS), the Zimbardo Time Perspective Inventory (ZTPI), and the Mindfulness Attention Awareness Scale (MAAS). Results show significant positive relationships between LS, mindfulness, and past positive, as well as negative associations between LS, past negative, and an unbalanced TP. Mindfulness also correlated inversely with an unbalanced TP. Regression analyses showed that 27% of variance in LS could be explained by the past negative and past positive ZTPI measures together with the MAAS. These results confirm the conclusions of previous studies conducted in culturally different populations and reinforce the hypothesis that mindfulness provides a holistic TP that intrinsically balances TP and increases LS. These findings suggest that a mindful attitude might be a key component of TP regulation that transcends different European cultural backgrounds.