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

Journal of Clinical Medicine, vol. 9, pp. 3246

Abstract

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.

Authors 11

1. Juan P. Sanabria‐Mazo

   Universitat Autònoma de Barcelona · Universitat Internacional de Catalunya · Parc Sanitari Sant Joan de Déu · Institut de Recerca Sant Joan de Déu

   Affiliation as printed

   Department of Medicine, International University of Catalonia, C/Josep Trueta s/n, Sant Cugat del Vallès, 08195 Barcelona, Spain

   Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain

   Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain

   Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, 08830 Barcelona, Spain

2. Jesús Montero‐Marín

   Warneford Hospital · University of Oxford

   Affiliation as printed

   Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK

3. Albert Feliu‐Soler corresponding

   Universitat Autònoma de Barcelona · Parc Sanitari Sant Joan de Déu · Institut de Recerca Sant Joan de Déu

   Affiliation as printed

   Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain

   Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain

   Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, 08830 Barcelona, Spain

4. Virginia Gasión

   Hospital Universitario Miguel Servet · Instituto de Investigación Sanitaria Aragón

   Affiliation as printed

   Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain

5. Mayte Navarro‐Gil

   Red de Investigación en Actividades Preventivas y Promoción de la Salud · Hospital Universitario Miguel Servet · Instituto de Investigación Sanitaria Aragón

   Affiliation as printed

   Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain

   Primary Care Prevention and Health Promotion Research Network, RedIAPP, 28220 Madrid, Spain

6. Héctor Morillo‐Sarto

   Universidad de Zaragoza

   Affiliation as printed

   Basic Psychology Department, Faculty of Psychology, University of Zaragoza, 44003 Teruel, Spain

7. Ariadna Colomer‐Carbonell

   Universitat Autònoma de Barcelona · Parc Sanitari Sant Joan de Déu · Institut de Recerca Sant Joan de Déu

   Affiliation as printed

   Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain

   Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain

   Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, 08830 Barcelona, Spain

8. Xavier Borràs

   Universitat Autònoma de Barcelona

   Affiliation as printed

   Faculty of Psychology, Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), 08193 Barcelona, Spain

9. Mattie Tops Aachen Developmental and Educational Psychology Unit

   Leiden University

   Affiliation as printed

   Developmental and Educational Psychology Unit, Leiden University, 233 AK Leiden, The Netherlands

10. Juan Vicente Luciano corresponding

    Parc Sanitari Sant Joan de Déu · Institut de Recerca Sant Joan de Déu

    Affiliation as printed

    Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, 08950 Barcelona, Spain

    Teaching, Research & Innovation Unit, Parc Sanitari Sant Joan de Déu, St. Boi de Llobregat, 08830 Barcelona, Spain

11. Javier García‐Campayo

    Red de Investigación en Actividades Preventivas y Promoción de la Salud · Hospital Universitario Miguel Servet · Instituto de Investigación Sanitaria Aragón

    Affiliation as printed

    Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, 50009 Zaragoza, Spain

    Primary Care Prevention and Health Promotion Research Network, RedIAPP, 28220 Madrid, Spain