Reduced Ability to Make Decisions: a Study That Observe Differences in Patients With Fibromyalgia and Healthy Control
NCT ID: NCT06118970
Last Updated: 2024-05-08
Study Results
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Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2024-05-05
2024-12-31
Brief Summary
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The aim of this study is to evaluate decision-making skills in a group of patients with fibromyalgia and compare these results with a group of healthy controls. Specifically, investigators will evaluate four hypotheses:
1. Patients with fibromyalgia may show disadvantageous decision-making in contexts of emotional decision-making and may persevere more in their wrong choices. For this reason, investigators hypothesize that patients with fibromyalgia will more frequently choose the disadvantageous decks than the healthy control group in the Iowa Gambling Task.
2. Secondly, investigators hypothesize that patients with fibromyalgia need more time to make their choice. Consistent with this hypothesis, researchers expect to find significant differences in the average time taken by the participant to make a choice in the Iowa Gambling Task.
3. The third hypothesis is that patients with fibromyalgia may have greater difficulty inhibiting automatic responses, which may lead to longer reaction times in the Stroop task. Investigators also hypothesize that stimuli with negative emotional valence (related to the typical pain experience in fibromyalgia) may have a greater effect on patients with fibromyalgia than on healthy controls (longer reaction time in the emotional Stroop Task compared to healthy controls).
4. Finally, investigators hypothesize that anxiety, depression, sleep quality, pain, decision-making style and social support may be related to worse performance in ability-based tasks.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Patients with fibromyalgia syndrome
Patients with fibromyalgia will be recruited at the UZ hospital in Brussels, at local patient organisations (e.g. VLFP), at the Vrije Universiteit Brussel and via social media alerts.
This syndrome must be confirmed by a medical diagnosis. Participants should be able to understand English, Dutch or French, they must have signed an in-formed consent and they must be at least 18 years old. Patients with other diagnoses will be excluded from this study (e.g., osteoarthritis, rheumatoid arthritis, post-cancer pain, as well as patients with primary psychiatric/neurological conditions or psychopathological disorders). Subjects with a history of substance abuse or pathological gambling and individuals with color blindness will also be excluded.
Neuropsychological tasks and self-report questionnaires
Being a cross-sectional observational study, no intervention will be administered. Subjects will be assessed with neuropsychological tasks and self-report questionnaires.
Healthy controls
Healthy controls will be recruited through the University of Brussels or through social media alerts. Their exclusion criteria included, in addition to those specified for the fibromyalgia group, those who were suffering from fibromyalgia or had a severe rheumatic illness. Subjects should not have pain currently or have a recent history of pain (within the past 3 months).
Neuropsychological tasks and self-report questionnaires
Being a cross-sectional observational study, no intervention will be administered. Subjects will be assessed with neuropsychological tasks and self-report questionnaires.
Interventions
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Neuropsychological tasks and self-report questionnaires
Being a cross-sectional observational study, no intervention will be administered. Subjects will be assessed with neuropsychological tasks and self-report questionnaires.
Eligibility Criteria
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Inclusion Criteria
* Able to understand English, Dutch or French;
* Signed an informed consent.
Exclusion Criteria
* History of substance abuse or pathological gambling;
* Color blindness;
* Not have pain currently or have a recent history of pain (ONLY FOR HEALTY CONTROL GROUP).
18 Years
ALL
Yes
Sponsors
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Vrije Universiteit Brussel
OTHER
Responsible Party
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Andrea Polli
postdoctoral researcher
Principal Investigators
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Andrea Polli, Researcher
Role: PRINCIPAL_INVESTIGATOR
Vrije Universiteit Brussel
Locations
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Vrije Universiteit Brussel
Brussels, Brussels Capital, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Vecchio E, Lombardi R, Paolini M, Libro G, Delussi M, Ricci K, Quitadamo SG, Gentile E, Girolamo F, Iannone F, Lauria G, de Tommaso M. Peripheral and central nervous system correlates in fibromyalgia. Eur J Pain. 2020 Sep;24(8):1537-1547. doi: 10.1002/ejp.1607. Epub 2020 Jun 16.
Wu YL, Huang CJ, Fang SC, Ko LH, Tsai PS. Cognitive Impairment in Fibromyalgia: A Meta-Analysis of Case-Control Studies. Psychosom Med. 2018 Jun;80(5):432-438. doi: 10.1097/PSY.0000000000000575.
Alfeo F, Decarolis D, Clemente L, Delussi M, de Tommaso M, Curci A, Lanciano T. Decision Making and Fibromyalgia: A Systematic Review. Brain Sci. 2022 Oct 27;12(11):1452. doi: 10.3390/brainsci12111452.
Walteros C, Sanchez-Navarro JP, Munoz MA, Martinez-Selva JM, Chialvo D, Montoya P. Altered associative learning and emotional decision making in fibromyalgia. J Psychosom Res. 2011 Mar;70(3):294-301. doi: 10.1016/j.jpsychores.2010.07.013.
Cuevas-Toro AM, Lopez-Torrecillas F, Diaz-Batanero MC, Perez-Marfil MN. Neuropsychological function, anxiety, depression and pain impact in fibromyalgia patients. Span J Psychol. 2014 Nov 14;17:E78. doi: 10.1017/sjp.2014.78.
Verdejo-Garcia A, Lopez-Torrecillas F, Calandre EP, Delgado-Rodriguez A, Bechara A. Executive function and decision-making in women with fibromyalgia. Arch Clin Neuropsychol. 2009 Feb;24(1):113-22. doi: 10.1093/arclin/acp014. Epub 2009 Mar 11.
Duschek S, Werner NS, Limbert N, Winkelmann A, Montoya P. Attentional bias toward negative information in patients with fibromyalgia syndrome. Pain Med. 2014 Apr;15(4):603-12. doi: 10.1111/pme.12360. Epub 2014 Jan 21.
Fischer-Jbali LR, Montoro CI, Montoya P, Halder W, Duschek S. Central nervous activity during an emotional Stroop task in fibromyalgia syndrome. Int J Psychophysiol. 2022 Jul;177:133-144. doi: 10.1016/j.ijpsycho.2022.05.009. Epub 2022 May 16.
Mercado F, Gonzalez JL, Barjola P, Fernandez-Sanchez M, Lopez-Lopez A, Alonso M, Gomez-Esquer F. Brain correlates of cognitive inhibition in fibromyalgia: emotional intrusion of symptom-related words. Int J Psychophysiol. 2013 May;88(2):182-92. doi: 10.1016/j.ijpsycho.2013.03.017. Epub 2013 Apr 2.
Other Identifiers
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DeMa_FM_P01
Identifier Type: -
Identifier Source: org_study_id
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