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Clinical Trials/NCT06118970
NCT06118970
Recruiting
N/A

Impaired Decision-making Capacity in Patients Suffering From Fibromyalgia: a Cross-sectional Study

Vrije Universiteit Brussel1 site in 1 country90 target enrollmentMay 5, 2024
ConditionsFibromyalgia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Vrije Universiteit Brussel
Enrollment
90
Locations
1
Primary Endpoint
Iowa gambling task (IGT)
Status
Recruiting
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
May 5, 2024
End Date
December 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Polli

postdoctoral researcher

Vrije Universiteit Brussel

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).

Outcomes

Primary Outcomes

Iowa gambling task (IGT)

Time Frame: Baseline (cross sectional)

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.

Secondary Outcomes

  • Stroop task and Emotional Stroop task(Baseline (cross sectional))

Study Sites (1)

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