A randomized controlled efficacy trial of Mindfulness-Based Stress Reduction compared to an active control group and usual care for fibromyalgia: the EUDAIMON study.
Adrián Pérez-aranda, Albert Feliu-Soler, Jesus Montero-Marin, Javier García-campayo, Laura Andrés-Rodríguez, Xavier Borràs, A. Rozadilla-Sacanell, M. Peñarrubia-María, N. Angarita-Osorio, Lance M. McCracken, Juan V Luciano
Pain August 13, 2019 DOI: 10.1097/j.pain.0000000000001655 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 225 |
| Population | People with fibromyalgia syndrome |
| Interventions | Mindfulness-Based Stress Reduction (MBSR) FibroQoL |
| Duration | 8-week intervention, 12-month follow-up |
| Topics | Meditation |
| Key findings | MBSR plus usual care reduces functional impairment in fibromyalgia more than usual care alone, with effects mediated by psychological inflexibility and acting with awareness. |
Abstract
Fibromyalgia syndrome (FM) represents a great challenge for clinicians and researchers because the efficacy of currently available treatments is limited. The present 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. 225 participants with FM were randomized into three 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. MBSR 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 long-term it was only modestly better (significant differences only in pain catastrophising and fibromyalginess). Immediately post-treatment, the NNT for 20% improvement in MBSR versus TAU and FibroQoL was 4.0 (95%CI= 2.1-6.5) and 5.0 (95%CI= 2.7-37.3). An unreliable NNT 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.
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 20
- Research in Mindfulness Interventions for Patients With Fibromyalgia: A Critical Review. Frontiers in Integrative Neuroscience July 28, 2022
- Mind-body therapy for treating fibromyalgia: a systematic review. Pain Medicine August 2, 2024
- Mindfulness-based stress reduction (MBSR) for fibromyalgia patients: The role of pain cognitions as mechanisms of change. Complementary Therapies in Clinical Practice August 1, 2024
- About Distress in Chronic Pain Conditions: A Pre-Post Study on the Effectiveness of a Mindfulness-Based Intervention for Fibromyalgia and Low Back Pain Patients. International Journal of Environmental Research and Public Health November 13, 2024
- 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
and 15 more in the library
Cites 15
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Home practice in Mindfulness-Based Cognitive Therapy and Mindfulness-Based Stress Reduction: A systematic review and meta-analysis of participants' mindfulness practice and its association with outcomes Behaviour Research and Therapy May 10, 2017
- Mindfulness meditation alleviates depressive symptoms in women with fibromyalgia: Results of a randomized clinical trial Arthritis Care & Research January 31, 2007
- Effect of Mindfulness‐Based stress reduction in rheumatoid arthritis patients Arthritis Care & Research September 28, 2007
- 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) BMC Complementary and Alternative Medicine February 27, 2016
and 10 more in the library