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A randomized controlled efficacy trial of mindfulness-based stress reduction compared with an active control group and usual care for fibromyalgia: the EUDAIMON study
Abstract
Fibromyalgia (FM) syndrome represents a great challenge for clinicians and researchers because the efficacy of currently available treatments is limited. This study examined the efficacy of mindfulness-based stress reduction (MBSR) for reducing functional impairment as well as the role of mindfulness-related constructs as mediators of treatment outcomes for people with FM. Two hundred twenty-five participants with FM were randomized into 3 study arms: MBSR plus treatment-as-usual (TAU), FibroQoL (multicomponent intervention for FM) plus TAU, and TAU alone. The primary endpoint was functional impact (measured with the Fibromyalgia Impact Questionnaire Revised), and secondary outcomes included "fibromyalginess," anxiety and depression, pain catastrophising, perceived stress, and cognitive dysfunction. The differences in outcomes between groups at post-treatment assessment (primary endpoint) and 12-month follow-up were analyzed using linear mixed-effects models and mediational models through path analyses. Mindfulness-based stress reduction was superior to TAU both at post-treatment (large effect sizes) and at follow-up (medium to large effect sizes), and MBSR was also superior to FibroQoL post-treatment (medium to large effect sizes), but in the long term, it was only modestly better (significant differences only in pain catastrophising and fibromyalginess). Immediately post-treatment, the number needed to treat for 20% improvement in MBSR vs TAU and FibroQoL was 4.0 (95% confidence interval [CI] = 2.1-6.5) and 5.0 (95% CI = 2.7-37.3). An unreliable number needed to treat value of 9 (not computable 95% CI) was found for FibroQoL vs TAU. Changes produced by MBSR in functional impact were mediated by psychological inflexibility and the mindfulness facet acting with awareness. These findings are discussed in relation to previous studies of psychological treatments for FM.
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“Mindfulness correlates with a broad battery of symptoms related to psychological wellbeing (27)”
From Identifying mindfulness and acceptance as mediators between negative affect, functional disability and emotional distress in patients with fibromyalgia (2021) · cites this paper as [27]
In the citing paper
“Mindfulness and ACT increases the experience of positive subjective experiences, enhances active coping and promotes physiological deactivation in the short term, and in the long term, it minimises the risk of depression and reinforces coping resources (27, 47, 55, 57).”
From Identifying mindfulness and acceptance as mediators between negative affect, functional disability and emotional distress in patients with fibromyalgia (2021) · cites this paper as [27]
In the citing paper
“Unexpectedly, the effect size of the intervention on PIPS scores was smaller than expected in the present sample, as significant changes with moderate-to-large effect sizes (d = 0.70) were found in the EUDAIMON study when including the whole study sample (n = 225) [27].”
From The bed nucleus of the stria terminalis as a brain correlate of psychological inflexibility in fibromyalgia (2020) · cites this paper as [27]
In the citing paper
“It was developed in a previous RCT36 and will be used to check the presence of negative effects of ACT and BATD.”
From Efficacy, cost-utility and physiological effects of Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment for Depression (BATD) in patients with chronic low back pain and depression: study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study) (2020) · cites this paper as [36]
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Metadata
- Authors
- Pérez-Aranda, A., Feliu-Soler, A., Montero-Marín, J., García-Campayo, J., Andrés-Rodríguez, L., Borràs, X., Rozadilla-Sacanell, A., Peñarrubia-Maria, M. T., Angarita-Osorio, N., McCracken, L. M., & Luciano, J. V.
- Affiliations
- Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain
- Dharamsala Institute of Mindfulness and Psychotherapy, Zaragoza, Spain
- Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain
- Universitat Autònoma de Barcelona (ES)
- Rheumatology Service, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain
- Primary Health Centre Bartomeu Fabrés Anglada, SAP Delta Llobregat, Unitat Docent Costa de Ponent, Institut Català de la Salut, Gavà, Spain
- Uppsala University (SE)
- Red de Investigación en Actividades Preventivas y Promoción de la Salud (ES)
- Venue
- Pain
- Published
- 2019-08-13
- Volume
- 160
- Issue
- 11
- Pages
- 2508-2523
- ISSN
- 0304-3959 (ISSN-L)
- 1872-6623
- OpenAlex
- W2964390861
- Cited by
- 98
- References
- 86
- Citations by year
- 2026: 16 · 2025: 8 · 2024: 12 · 2023: 16 · 2022: 18 · 2021: 15 · 2020: 12 · 2019: 1
- FWCI
- 9.14
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Keywords
- fibromyalgia, mindfulness-based stress reduction, functional disability, psychological inflexibility, mindfulness facets, pain catastrophizing, perceived stress, anxiety and depression, cognitive impairment, number needed to treat, psychological intervention
- MeSH terms
- Adolescent, Adult, Aged, Anxiety, Awareness, Depression, Female, Fibromyalgia, Humans, Male, Middle Aged, Quality of Life, Stress, Psychological, Young Adult, Mindfulness
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