Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)

BDNF; Cytokines; FibromyalgiaBDNF; Citocinas; FibromialgiaBDNF; Citocines; FibromiàlgiaIntroduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre-post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes. Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d'Hebron University Hospital (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs. TAU + FIBRO-On vs. TAU + FIBRO-Out. A comprehensive assessment to collect functional impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed

Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia : Study protocol of a randomized, controlled trial (On&Out study)

Introduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre-post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes. Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d'Hebron University Hospital (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs. TAU + FIBRO-On vs. TAU + FIBRO-Out. A comprehensive assessment to collect functional impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed. Ethics and dissemination: This study has been approved by the Ethics Committee of the Vall d'Hebron Institute of Research. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities. Trial registration number NCT05377567 ()

Effectiveness of an online multicomponent program (FATIGUEWALK) for Chronic Fatigue Syndrome : a randomized controlled trial

OBJECTIVE: This study aimed to evaluate the effectiveness of an online multicomponent intervention called FATIGUEWALK (FaW) compared to treatment as usual (TAU) in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). METHOD: FaW included pain neuroscience education, therapeutic exercise, cognitive restructuring, and mindfulness training. A total of 428 patients with CFS/ME were randomized into two study arms: online FaW plus TAU versus TAU alone. A single-blinded randomized controlled trial was conducted. Validated patient-reported outcome measures of fatigue, pain, anxiety, depression, and physical function were collected at baseline and posttreatment, following the FaW intervention, which lasted 12 weeks. RESULTS: Statistically significant improvements (with small-to-moderate effect sizes) were observed in online FaW versus TAU alone with respect to multidimensional aspects of fatigue (Cohen's d ranging from 0.25 to 0.73) and most secondary outcomes (pain and fatigue intensity, depressive and anxious symptomatology, functional impairment, kinesiophobia, physical functioning). The absolute risk reduction in FaW versus TAU was 19%, 95% confidence interval (CI) [12.19, 25.80] with number needed to treat = 6, 95% CI [3.9, 8.2]. Overall, similar clinical improvements were observed in sensitivity analyses including a subgroup of patients without comorbidity with fibromyalgia ( n = 70). CONCLUSIONS: This is the first study to assess the short-term effectiveness of an online multicomponent intervention added to TAU, compared to TAU alone, for the management of CFS/ME. Further trials, including active control groups with an equivalent treatment dose, and assessing the long-term effectiveness of the online FaW, are warranted. (PsycInfo Database Record (c) 2023 APA, all rights reserved).Objetivo: Este estudio tuvo como objetivo evaluar la efectividad de una intervención multicomponente en línea llamada FATIGUEWALK (FaW) en comparación con el tratamiento habitual (TAU, por sus siglas en inglés) en pacientes con síndrome de fatiga crónica/encefalomielitis miálgica (CFS/ME, por sus siglas en inglés). Método: FaW incluyó educación en neurociencia del dolor, ejercicio terapéutico, reestructuración cognitiva y entrenamiento de atención plena. Un total de 428 pacientes con CFS/ME fueron asignados aleatoriamente a dos grupos de estudio: FaW en línea más TAU versus TAU solo. Se llevó a cabo un estudio controlado aleatorio (ECA) simple ciego. Se recopilaron medidas de resultado validadas informadas por los pacientes de fatiga, dolor, ansiedad, depresión y función física al inicio y después del tratamiento, después de la intervención FaW, que duró 12 semanas. Resultados: Se observaron mejoras estadísticamente significativas (con tamaños de efecto pequeños a moderados) en FaW en línea versus TAU solo con respecto a los aspectos multidimensionales de la fatiga (la d de Cohen oscila entre 0.25 y 0.73) y la mayoría de los resultados secundarios (intensidad de dolor y la fatiga, depresión y ansiedad sintomatológica, deterioro funcional, kinesiofobia, funcionamiento físico). La reducción del riesgo absoluto en FaW versus TAU fue del 19% (IC del 95% = [12.19, 25.80]) con número necesario a tratar (NNT) = 6 (IC del 95% = 3.9-8.2). En general, se observaron mejoras clínicas similares en los análisis de sensibilidad que incluyeron un subgrupo de pacientes sin comorbilidad con fibromialgia (n = 70). Conclusiones: Este es el primer estudio que evalúa la efectividad a corto plazo de una intervención multicomponente en línea agregada a TAU, en comparación con TAU sola, para el tratamiento del CFS/ME. Se justifican ensayos adicionales, que incluyan grupos de control activo con una dosis de tratamiento equivalente y que evalúen la eficacia a largo plazo del FaW en línea