Digging into the construct of fibrofog: Psychometric properties of the Spanish version of the Multidimensional Inventory of Subjective Cognitive Impairment in patients with fibromyalgia

Feliu‐Soler, Albert; Pérez‐Aranda, Adrián; Andrés‐Rodríguez, Laura; Butjosa, Anna; Díaz, Natalia Sylvia Ramos; Trujols, Joan; Núñez, Christian; Stephan‐Otto, Christian; Rozadilla-Sacanell, Antoni; Serrano‐Blanco, Antoni; Kratz, Anna L.; Luciano, Juan V.

doi:10.1111/jabr.12134

Cited by 9 publications

(7 citation statements)

References 74 publications

(120 reference statements)

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“…It is possible that some of the effects of MBSR could be universally attributed to/mediated by the reduction of anxiety and depression. 112 Our preliminary results suggest that MBSR is not a program that can improve cognitive functions more rapidly compared to standard cognitive training. However, the interpretation of these results does not necessarily indicate the ineffectiveness of MBSR in this area, as the results are compared to active intervention.…”

Section: Discussionmentioning

confidence: 76%

<p>The Effect of Mindfulness-Based Stress Reduction (MBSR) on Depression, Cognition, and Immunity in Mild Cognitive Impairment: A Pilot Feasibility Study</p>

Marciniak¹,

Šumec²,

Vyhnálek³

et al. 2020

CIA

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Background: Mindfulness-based programs have shown a promising effect on several health factors associated with increased risk of dementia and the conversion from mild cognitive impairment (MCI) to dementia such as depression, stress, cognitive decline, immune system and brain structural and functional changes. Studies on mindfulness in MCI subjects are sparse and frequently lack control intervention groups. Objective: To determine the feasibility and the effect of mindfulness-based stress reduction (MBSR) practice on depression, cognition and immunity in MCI compared to cognitive training. Methods: Twenty-eight MCI subjects were randomly assigned to two groups. MBSR group underwent 8-week MBSR program. Control group underwent 8-week cognitive training. Their cognitive and immunological profiles and level of depressive symptoms were examined at baseline, after each 8-week intervention (visit 2, V2) and six months after each intervention (visit 3, V3). MBSR participants completed feasibility questionnaire at V2. Results: Twenty MCI patients completed the study (MBSR group n=12, control group n=8). MBSR group showed significant reduction in depressive symptoms at both V2 (p=0.03) and V3 (p=0.0461) compared to the baseline. There was a minimal effect on cognition-a group comparison analysis showed better psychomotor speed in the MBSR group compared to the control group at V2 (p=0.0493) but not at V3. There was a detectable change in immunological profiles in both groups, more pronounced in the MBSR group. Participants checked only positive/neutral answers concerning the attractivity/length of MBSR intervention. More severe cognitive decline (PVLT≤36) was associated with the lower adherence to home practice. Conclusion: MBSR is well-accepted potentially promising intervention with positive effect on cognition, depressive symptoms and immunological profile.

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Section: Discussionmentioning

confidence: 76%

<p>The Effect of Mindfulness-Based Stress Reduction (MBSR) on Depression, Cognition, and Immunity in Mild Cognitive Impairment: A Pilot Feasibility Study</p>

Marciniak¹,

Šumec²,

Vyhnálek³

et al. 2020

CIA

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“…The Spanish version of the MISCI had sound psychometric properties (α=0.91 and intraclass correlation coefficient, ICC=0.88). 52 …”

Section: Methods and Analysismentioning

confidence: 99%

“…The Spanish version of the MISCI had sound psychometric properties (α=0.91 and intraclass correlation coefficient, ICC=0.88). 52 The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 53 is a 12-item self-report measure of the level of difficulty experienced taking into consideration how they usually do the activity. This includes the use of any devices to assist them and/or the help of a person.…”

Section: Open Accessmentioning

confidence: 99%

Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost–utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study)

et al. 2022

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IntroductionThere is evidence that low-dose naltrexone (LDN; <5.0 mg/day) reduces pain and improves the quality of life of people with fibromyalgia syndrome (FMS). However, no randomised controlled trials with long-term follow-ups have been carried out. The INNOVA study will evaluate the add-on efficacy, safety, cost–utility and neurobiological effects of LDN for reducing pain in patients with FMS, with a 1-year follow-up.Methods and analysisA single-site, prospective, randomised, double-blinded, placebo-controlled, parallel design phase III trial will be performed. Eligibility criteria include being adult, having a diagnosis of FMS and experiencing pain of 4 or higher on a 10-point numerical rating scale. Participants will be randomised to a LDN intervention group (4.5 mg/day) or to a placebo control group. Clinical assessments will be performed at baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3). The primary endpoint will be pain intensity. A sample size of 60 patients per study arm (120 in total), as calculated prior to recruitment for sufficient power, will be monitored between January 2022 and August 2024. Assessment will also include daily ecological momentary evaluations of FMS-related symptoms (eg, pain intensity, fatigue and sleep disturbance), and side effects via ecological momentary assessment through the Pain Monitor app during the first 3 months. Costs and quality-adjusted life years will be also calculated. Half of the participants in each arm will be scanned with MRI at T0 and T1 for changes in brain metabolites related to neuroinflammation and central sensitisation. Inflammatory biomarkers in serum will also be measured.Ethics and disseminationThis study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and community engagement activities.Trial registration numberNCT04739995.

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“…- The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI; Feliu-Soler et al, 2018 ) is a 10-item scale with a 5-point Likert scale (from 1 “Not at all/Never” to 5 “Very much/Always”) for assessing perceived cognitive dysfunction in FM during last week. It includes the cognitive domains: mental clarity, memory, attention/concentration, executive functioning, and language.…”

Section: Methodsmentioning

confidence: 99%

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)

et al. 2022

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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 (clinicaltrials.gov).

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Digging into the construct of fibrofog: Psychometric properties of the Spanish version of the Multidimensional Inventory of Subjective Cognitive Impairment in patients with fibromyalgia

Cited by 9 publications

References 74 publications

<p>The Effect of Mindfulness-Based Stress Reduction (MBSR) on Depression, Cognition, and Immunity in Mild Cognitive Impairment: A Pilot Feasibility Study</p>

<p>The Effect of Mindfulness-Based Stress Reduction (MBSR) on Depression, Cognition, and Immunity in Mild Cognitive Impairment: A Pilot Feasibility Study</p>

Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost–utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study)

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)

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