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Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

1
Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain
2
Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, 08830 Barcelona, Spain
3
Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain
4
Department of Medicine, International University of Catalonia, C/Josep Trueta s/n, Sant Cugat del Vallès, 08195 Barcelona, Spain
5
Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK
6
Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain
7
Primary Care Prevention and Health Promotion Research Network, RedIAPP, 28220 Madrid, Spain
8
Basic Psychology Department, Faculty of Psychology, University of Zaragoza, 44003 Teruel, Spain
9
Developmental and Educational Psychology Unit, Leiden University, 233 AK Leiden, The Netherlands
*
Authors to whom correspondence should be addressed.
Both authors contributed equally to this paper and should be considered as co-first authors.
These authors share senior authorship.
J. Clin. Med. 2020, 9(10), 3246; https://doi.org/10.3390/jcm9103246
Received: 22 September 2020 / Revised: 2 October 2020 / Accepted: 8 October 2020 / Published: 11 October 2020
The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum. View Full-Text
Keywords: fibromyalgia; mindfulness; amygdala and insula retraining; mind–body techniques; multicomponent intervention; brain-derived neurotrophic factor; immune-inflammatory markers; randomized controlled trial; pilot study fibromyalgia; mindfulness; amygdala and insula retraining; mind–body techniques; multicomponent intervention; brain-derived neurotrophic factor; immune-inflammatory markers; randomized controlled trial; pilot study
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Sanabria-Mazo, J.P.; Montero-Marin, J.; Feliu-Soler, A.; Gasión, V.; Navarro-Gil, M.; Morillo-Sarto, H.; Colomer-Carbonell, A.; Borràs, X.; Tops, M.; Luciano, J.V.; García-Campayo, J. Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial. J. Clin. Med. 2020, 9, 3246.

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