Reduced Ability to Make Decisions: a Study That Observe Differences in Patients With Fibromyalgia and Healthy Control

NCT06118970 | Recruiting

• 1 other identifier: DeMa_FM_P01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 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. 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. 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. 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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Decision making; Stroop task; Iowa gambling task

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Stroop task and Emotional Stroop task

  Baseline (cross sectional)

Other Outcomes (7)

• Fibromyalgia Impact Questionnaire (FIQ)

  Baseline (cross sectional)

• The Multidimensional Scale of Perceived Social Support (MSPSS)

  Baseline (cross sectional)

• Brief Pain Inventory (BPI)

  Baseline (cross sectional)

Study Arms (2)

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.

Other: 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).

Other: Neuropsychological tasks and self-report questionnaires

Interventions

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.

Healthy controls; Patients with fibromyalgia syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Fibromyalgia syndrome (confirmed by a medical diagnosis);
• Able to understand English, Dutch or French;
• Signed an informed consent.

You may not qualify if:

• Other diagnoses (osteoarthritis, rheumatoid arthritis, post-cancer pain, as well as patients with primary psychiatric/neurological conditions or psychopathological disorders);
• 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).

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Brussels Capital, 1000, Belgium

RECRUITING

Related Publications (9)

• 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.

  PMID: 32478943 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.

  PMID: 29528888 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.

  PMID: 36358377 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.

  PMID: 21334501 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.

  PMID: 26054236 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.

  PMID: 19395361 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.

  PMID: 24447855 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.

  PMID: 35588963 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.

  PMID: 23557844 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Andrea Polli, Researcher

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Garzonio, Msc student

CONTACT

00393496243671; stefano.garzonio@vub.be

Zosia Goossens, PhD student

CONTACT

Zosia.Goossens@vub.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postdoctoral researcher

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: May 5, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

BE (1)