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.
Fibromyalgia (FM) is a prevalent, chronic, disabling, pain syndrome that implies high healthcare costs. Economic evaluations of potentially effective treatments for FM are needed. The aim of this study was to analyze the cost–utility of Mindfulness-Based Stress Reduction (MBSR) as an add-on to treatment-as-usual (TAU) for patients with FM compared to an adjuvant multicomponent intervention (“FibroQoL”) and to TAU. We performed an economic evaluation alongside a 12 month, randomized, controlled trial; data from 204 (68 per study arm) of the 225 patients (90.1%) were included in the cost–utility analyses, which were conducted both under the government and the public healthcare system perspectives. The main outcome measures were the EuroQol (EQ-5D-5L) for assessing Quality-Adjusted Life Years (QALYs) and improvements in health-related quality of life, and the Client Service Receipt Inventory (CSRI) for estimating direct and indirect costs. Incremental cost-effectiveness ratios (ICERs) were also calculated. Two sensitivity analyses (intention-to-treat, ITT, and per protocol, PPA) were conducted. The results indicated that MBSR achieved a significant reduction in costs compared to the other study arms (p < 0.05 in the completers sample), especially in terms of indirect costs and primary healthcare services. It also produced a significant incremental effect compared to TAU in the ITT sample (ΔQALYs = 0.053, p < 0.05, where QALYs represents quality-adjusted life years). Overall, our findings support the efficiency of MBSR over FibroQoL and TAU specifically within a Spanish public healthcare context.
Fibromyalgia (FM) is a chronic syndrome characterized by widespread musculoskeletal pain, and physical and emotional symptoms. Although its pathophysiology is largely unknown, immune-inflammatory pathways may be involved. We examined serum interleukin (IL)-6, high sensitivity C-reactive protein (hs-CRP), CXCL-8, and IL-10 in 67 female FM patients and 35 healthy women while adjusting for age, body mass index (BMI), and comorbid disorders. We scored the Fibromyalgia Severity Score, Widespread Pain Index (WPI), Symptom Severity Scale (SSS), Hospital Anxiety (HADS-A), and Depression Scale and the Perceived Stress Scale (PSS-10). Clinical rating scales were significantly higher in FM patients than in controls. After adjusting for covariates, IL-6, IL-10, and CXCL-8 were lower in FM than in HC, whereas hs-CRP did not show any difference. Binary regression analyses showed that the diagnosis FM was associated with lowered IL-10, quality of sleep, aerobic activities, and increased HADS-A and comorbidities. Neural networks showed that WPI was best predicted by quality of sleep, PSS-10, HADS-A, and the cytokines, while SSS was best predicted by PSS-10, HADS-A, and IL-10. Lowered levels of cytokines are associated with FM independently from confounders. Lowered IL-6 and IL-10 signaling may play a role in the pathophysiology of FM.
Background Fibromyalgia (FM) is a prevalent and highly disabling chronic pain syndrome. However, differences among patients regarding how pain impacts on daily life are remarkable. The main aim of this study was to identify clinical and pain‐related cognitive variables characterizing patients reporting high adaptability despite experiencing severe chronic pain. Methods Two hundred and eighty‐three Spanish patients with FM with high levels of pain were classified into 2 groups: (1) those reporting low impact of the syndrome, and (2) those with moderate‐to‐high impact. Perceived stress, anxiety, and depressive symptoms along with pain catastrophizing, psychological inflexibility, and perceived control over pain were evaluated. Differences in sociodemographics, years with FM, past/current major depressive disorder comorbidity, and health‐related economic costs (ie, medications, use of medical services, lost productivity due to sick leave) were also assessed. Stepwise logistic regression analyses predicting group membership from clinical variables and pain‐related cognitive processes as predictors were performed. Results Lower stress, anxiety, and depressive symptoms, along with reduced pain catastrophism, psychological inflexibility, and perceived control over pain, were found in the low‐impact group. Significant predictors of group membership (low‐impact vs. moderate‐to‐high impact) in regression analyses were “cognitive fusion” (psychological inflexibility), “helplessness” (pain catastrophizing), and depressive symptomatology, together with pain intensity and other FM symptoms. Conclusions The present study provides further evidence on resilience resources in chronic pain by identifying some variables (ie, reduced depressive symptomatology, pain catastrophizing, and psychological inflexibility) differentially characterizing a profile of patients with FM who are especially able to adapt to high levels of pain.
Thought control ability is a vulnerability factor implicated in the etiology and maintenance of emotional disorders. This manuscript aims to systematically review the use and psychometric performance of the Thought Control Ability Questionnaire (TCAQ), designed to assess people's ability to control unwanted thoughts. Three electronic databases were searched for papers administering the TCAQ published in indexed peer-reviewed journals. Data (participants characteristics, country, study design, etc.) were extracted from the results for qualitative synthesis. The TCAQ's content validity, dimensionality, internal consistency, test-retest reliability, convergent/divergent validity, floor/ceiling effects, and interpretability were summarized. Two reviewers independently screened articles and assessed quality taking COSMIN criteria into account. Finally, the review included 17 papers. The TCAQ has been administered to healthy individuals, students, and adult patients, in six languages from nine countries. We found that the TCAQ, and its shorter versions, demonstrate robust reliability and adequate content validity. Of interest is the TCAQ's capacity to predict performance in diverse experimental tasks focused on thought control. The TCAQ unidimensionality has been supported in exploratory and confirmatory factor analyses. Regarding construct validity, the TCAQ is significantly related to a wide range of psychopathological measures of anxiety, worry, depression, obsessive-compulsive symptoms, etc. However, as only a few of the included studies had a longitudinal design, we are unable to draw firm conclusions about the measure's temporal stability. Moreover, psychometric aspects such as factorial invariance across different samples have not been analyzed. Despite these limitations, based on available psychometric evidence we can recommend using the TCAQ for measuring perceived control of unwanted thoughts.
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