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

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ClinicalTrials.gov Identifier: NCT06118970
Recruitment Status : Recruiting
First Posted : November 7, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Andrea Polli, Vrije Universiteit Brussel

Tracking Information
First Submitted Date October 31, 2023
First Posted Date November 7, 2023
Last Update Posted Date May 8, 2024
Actual Study Start Date May 5, 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 3, 2023)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 3, 2023)
Stroop task and Emotional Stroop task [ Time Frame: 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2024)
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Baseline (cross sectional) ]
    The FIQ is a solid, worldwide-used questionnaire with a history of 20 years consisting of three domains (functional domain, physical symptom domain, and mental symptom domain). It is composed of 10 questions. The first question contains 11 items related to the ability to perform large muscle tasks - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal line-ar scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morn-ing tiredness, stiffness, anxiety and depression. The internal consistency of the FIQ is high (Cronbach's Alpha> 0.80). The scale is translated and validated in French and Dutch.
  • The Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Baseline (cross sectional) ]
    The MSPSS assess an individual's perception of the social support he or she receives from family, friends, and significant others. It is a self-report measure and contains 12-items, rated on a 7-point Likert-type scale, ranging from 1 "very strongly disagree" to 7 "very strongly agree." The scale was divided into 3 subscales: family, friends, and significant other, with each section consisting of 4 items. The scale reports the three subscale scores and an overall total score. The average item rating is reported as the score for the subscales and for the total score. The internal consistency of the MSPSS is excellent (Cronbach's Alpha > 0.89). The scale is translated and validated in French and Dutch.
  • Brief Pain Inventory (BPI) [ Time Frame: Baseline (cross sectional) ]
    The BPI was developed to provide a quick and easy means of measuring pain intensity and the extent to which pain interferes in the lives of the pain sufferers. Using this measure, respondents rate their worst, least, average, and current pain intensity and rate the degree to which pain inter-feres with 7 domains of functioning (general activity, mood, walking ability, normal work, rela-tions with other persons, sleep, and enjoyment of life) on a scale of 0 to 10. In patients with chronic non-malignant pain the internal consistency (Cronbach's Alpha) was .85 for the intensity scale and .88 for the interference scale. The scale is translated and validated in French and translated in Dutch.
  • General Decision-Making Style (GDMS) [ Time Frame: Baseline (cross sectional) ]
    The GDMS was designed to assess how individuals approach decision situations. It distinguishes between 5 decision styles: a rational style, an avoidant style, a dependent style, an intuitive style and a spontaneous style. The scale consists of 25 items, each item has a score ranging from 1 to 5 (1= strongly disagree to 5= strongly agree). The internal consistency reliability (Cronbach's alpha) range between 0.62 and 0.84 for the five styles. The scale is translated and validated in French and Dutch.
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline (cross sectional) ]
    The HADS is a two-dimension scale developed to identify depression and anxiety among physi-cally ill patients. The HADS consists of 14 items, divided into two 7 subscales: anxiety (items reflect a state of generalized anxiety) and depression (focus on the concept of anhedonia). The respondent rates each item on a 4-point scale, higher scores indicate greater levels of anxiety or depression. The internal consistency of the HADS range from adequate to excellent (Cronbach's Alpha 0.67-0.93). The scale is translated and validated in French and Dutch.
  • Medical Outcomes Study Short Form 36 (SF-36) [ Time Frame: Baseline (cross sectional) ]
    The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life. It consists of 36-item measure divided into 8 subscales and 2 composite domains. The 8 subscales are: physical functioning, role limitations due to physical problems, general health perceptions, vitality, social functioning, role limitations due to emotion-al problems, general mental health and health transition. The internal consistency of the SF-36 in chronic pain population is good (Cronbach's Alpha 0.76). The scale is translated and validated in French and Dutch.
  • Insomnia Severity Index (ISI) [ Time Frame: Baseline (cross sectional) ]
    The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insom-nia. the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime func-tioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).The internal consistency of the ISI range between good and excellent (Cronbach's Alpha 0.76 - 0.91). The scale is translated and validated in French and Dutch.
Original Other Pre-specified Outcome Measures
 (submitted: November 3, 2023)
  • Revised Fibromyalgia Impact Questionnaire [ Time Frame: Baseline (cross sectional) ]
    The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia (FM) patients. It has 21 individual questions. It is divided into three linked sets of domains: 'function' (9 questions), 'overall impact' (2 questions) and 'symptoms' (10 questions).
  • Medical Outcomes Study Social Support Survey [ Time Frame: Baseline (cross sectional) ]
    It is is a 19-item validated evaluation of social support. The Social Support Survey measures subscale domains that include emotional/information support, tangible support, affectionate support, and positive social interaction support.
  • Brief Pain Inventory [ Time Frame: Baseline (cross sectional) ]
    The BPI was developed to provide a quick and easy means of measuring pain intensity and the extent to which pain interferes in the lives of the pain sufferers.
  • General Decision-Making Style [ Time Frame: Baseline (cross sectional) ]
    The GDMS was designed to assess how individuals approach decision situations. It distinguishes between 5 decision styles: a rational style, an avoidant style, a dependent style, an intuitive style and a spontaneous style. The scale consists of 25 items, each item has a score ranging from 1 to 5 (1= strongly disagree to 5= strongly agree).
  • Mental Health Index [ Time Frame: Baseline (cross sectional) ]
    The MHI is an 18-item questionnaire composed of four subscales (anxiety, depression, behavioural control, and positive affect) and 1 total score. Each item has a score ranging from 1 to 6 (1= all of the time to 6= none of the time).
  • Pittsburgh Sleep Quality Index [ Time Frame: Baseline (cross sectional) ]
    The PSQI is the most commonly used generic measure of subjective self-report sleep quality. The measure consists of 19 self-reported items. The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Fibromyalgia
Intervention Other: Neuropsychological tasks and self-report questionnaires
Being a cross-sectional observational study, no intervention will be administered. Subjects will be assessed with neuropsychological tasks and self-report questionnaires.
Study Groups/Cohorts
  • 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.

    Intervention: 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).
    Intervention: Other: Neuropsychological tasks and self-report questionnaires
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 3, 2023)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Stefano Garzonio, Msc student 00393496243671 stefano.garzonio@vub.be
Contact: Zosia Goossens, PhD student Zosia.Goossens@vub.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT06118970
Other Study ID Numbers DeMa_FM_P01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Andrea Polli, Vrije Universiteit Brussel
Original Responsible Party Andrea Polli, Vrije Universiteit Brussel, Researcher
Current Study Sponsor Vrije Universiteit Brussel
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Andrea Polli, Researcher Vrije Universiteit Brussel
PRS Account Vrije Universiteit Brussel
Verification Date May 2024