跳至主要内容
临床试验/NCT06118970
NCT06118970招募中不适用

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

Vrije Universiteit Brussel1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Iowa gambling task (IGT)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Iowa gambling task (IGT)

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Polli

postdoctoral researcher

Vrije Universiteit Brussel

研究点 (1)

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