Clinical trial NCT06118970: Reduced Ability to Make Decisions: a Study That Observe Differences in Patients With Fibromyalgia and Healthy Control
Official title: Impaired Decision-making Capacity in Patients Suffering From Fibromyalgia: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Decision making
Stroop task
Iowa gambling task
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Iowa gambling task (IGT)
timeFrame: Baseline (cross sectional)
Secondary outcomes:
measure: Stroop task and Emotional Stroop task
timeFrame: Baseline (cross sectional)
Other outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Baseline (cross sectional)
measure: The Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline (cross sectional)
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline (cross sectional)
measure: General Decision-Making Style (GDMS)
timeFrame: Baseline (cross sectional)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (cross sectional)
measure: Medical Outcomes Study Short Form 36 (SF-36)
timeFrame: Baseline (cross sectional)
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline (cross sectional)
Locations:
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
state: Brussels Capital Region
Study officials:
affiliation: Vrije Universiteit Brussel
name: Andrea Polli, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.