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The literature has identified impairments in various cognitive functions, including learning, memory, attention, psychomotor speed, executive function, and working memory. However, only a few studies to date have investigated impairment in the decision-making process.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological tasks and self-report questionnaires | Other | Being a cross-sectional observational study, no intervention will be administered. Subjects will be assessed with neuropsychological tasks and self-report questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| Iowa gambling task (IGT) | This task is designed to assess cognitive function in emotional decision-making. It is a computerized decision-making task that involves uncertainty, risk assessment, and the evaluation of both reinforcement and punishment. | Baseline (cross sectional) |
| Measure | Description | Time Frame |
|---|---|---|
| Stroop task and Emotional Stroop task | The Stroop test is an instrument for assessing executive functions and aims to measure an individual's ability for selective attention, cognitive flexibility, and inhibition of automatic answers. The Stroop task can also be manipulated to examine how emotional stimuli disrupt colour-naming performance (Emotional Stroop task). | Baseline (cross sectional) |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) | The FIQ is a solid, worldwide-used questionnaire with a history of 20 years consisting of three domains (functional domain, physical symptom domain, and mental symptom domain). It is composed of 10 questions. The first question contains 11 items related to the ability to perform large muscle tasks - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal line-ar scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morn-ing tiredness, stiffness, anxiety and depression. The internal consistency of the FIQ is high (Cronbach's Alpha> 0.80). The scale is translated and validated in French and Dutch. |
Inclusion Criteria:
Exclusion Criteria:
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Residents in Belgium and Brussels, individuals belonging to fibromyalgia patient associations (e.g. VLFP), patients being treated at the UZ hospital in brussels in brussels.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Garzonio, Msc student | Contact | 00393496243671 | stefano.garzonio@vub.be | |
| Zosia Goossens, PhD student | Contact | Zosia.Goossens@vub.be |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Polli, Researcher | Vrije Universiteit Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrije Universiteit Brussel | Recruiting | Brussels | Brussels Capital | 1000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32478943 | Background | 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. | |
| 29528888 | Background | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Baseline (cross sectional) |
| The Multidimensional Scale of Perceived Social Support (MSPSS) | The MSPSS assess an individual's perception of the social support he or she receives from family, friends, and significant others. It is a self-report measure and contains 12-items, rated on a 7-point Likert-type scale, ranging from 1 "very strongly disagree" to 7 "very strongly agree." The scale was divided into 3 subscales: family, friends, and significant other, with each section consisting of 4 items. The scale reports the three subscale scores and an overall total score. The average item rating is reported as the score for the subscales and for the total score. The internal consistency of the MSPSS is excellent (Cronbach's Alpha > 0.89). The scale is translated and validated in French and Dutch. | Baseline (cross sectional) |
| Brief Pain Inventory (BPI) | The BPI was developed to provide a quick and easy means of measuring pain intensity and the extent to which pain interferes in the lives of the pain sufferers. Using this measure, respondents rate their worst, least, average, and current pain intensity and rate the degree to which pain inter-feres with 7 domains of functioning (general activity, mood, walking ability, normal work, rela-tions with other persons, sleep, and enjoyment of life) on a scale of 0 to 10. In patients with chronic non-malignant pain the internal consistency (Cronbach's Alpha) was .85 for the intensity scale and .88 for the interference scale. The scale is translated and validated in French and translated in Dutch. | Baseline (cross sectional) |
| General Decision-Making Style (GDMS) | The GDMS was designed to assess how individuals approach decision situations. It distinguishes between 5 decision styles: a rational style, an avoidant style, a dependent style, an intuitive style and a spontaneous style. The scale consists of 25 items, each item has a score ranging from 1 to 5 (1= strongly disagree to 5= strongly agree). The internal consistency reliability (Cronbach's alpha) range between 0.62 and 0.84 for the five styles. The scale is translated and validated in French and Dutch. | Baseline (cross sectional) |
| Hospital Anxiety and Depression Scale (HADS) | The HADS is a two-dimension scale developed to identify depression and anxiety among physi-cally ill patients. The HADS consists of 14 items, divided into two 7 subscales: anxiety (items reflect a state of generalized anxiety) and depression (focus on the concept of anhedonia). The respondent rates each item on a 4-point scale, higher scores indicate greater levels of anxiety or depression. The internal consistency of the HADS range from adequate to excellent (Cronbach's Alpha 0.67-0.93). The scale is translated and validated in French and Dutch. | Baseline (cross sectional) |
| Medical Outcomes Study Short Form 36 (SF-36) | The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life. It consists of 36-item measure divided into 8 subscales and 2 composite domains. The 8 subscales are: physical functioning, role limitations due to physical problems, general health perceptions, vitality, social functioning, role limitations due to emotion-al problems, general mental health and health transition. The internal consistency of the SF-36 in chronic pain population is good (Cronbach's Alpha 0.76). The scale is translated and validated in French and Dutch. | Baseline (cross sectional) |
| Insomnia Severity Index (ISI) | The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insom-nia. the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime func-tioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).The internal consistency of the ISI range between good and excellent (Cronbach's Alpha 0.76 - 0.91). The scale is translated and validated in French and Dutch. | Baseline (cross sectional) |
| 36358377 | Background | 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. |
| 21334501 | Background | 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. |
| 26054236 | Background | 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. |
| 19395361 | Background | 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. |
| 24447855 | Background | 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. |
| 35588963 | Background | 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. |
| 23557844 | Background | 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. |
| D009422 |
| Nervous System Diseases |