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

Recruiting

• Conditions: Fibromyalgia

• Registration Number: NCT06118970
• Lead Sponsor: Vrije Universiteit Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-07
• Status Verified: 2024-05
• Study Start: 2024-05-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Iowa gambling task (IGT)	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 Outcome Measures

Name	Time	Method
Stroop task and Emotional Stroop task	Baseline (cross sectional)	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).

Trial Locations

Locations (1)

Vrije Universiteit Brussel; 🇧🇪 Brussel, Brussels Capital Region, Belgium