Reduced Ability to Make Decisions: a Study That Observe Differences in Patients With Fibromyalgia and Healthy Control
NCT06118970, Unknown, Vrije Universiteit Brussel
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Reduced Ability to Make Decisions: a Study That Observe Differences in Patients With Fibromyalgia and Healthy Control | ClinicalTrials.gov |
| NCT number | NCT06118970 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Vrije Universiteit Brussel | ClinicalTrials.gov |
| Conditions | Fibromyalgia | ClinicalTrials.gov |
| Interventions | Neuropsychological tasks and self-report questionnaires | ClinicalTrials.gov |
| First posted | 2023-11-07 | ClinicalTrials.gov |
| Last updated | 2024-05-08 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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). | ClinicalTrials.gov |
| Other | Fibromyalgia Impact Questionnaire (FIQ) | 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. | ClinicalTrials.gov |
| Other | The Multidimensional Scale of Perceived Social Support (MSPSS) | 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. | ClinicalTrials.gov |
| Other | Brief Pain Inventory (BPI) | 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. | ClinicalTrials.gov |
| Other | General Decision-Making Style (GDMS) | 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. | ClinicalTrials.gov |
| Other | Hospital Anxiety and Depression Scale (HADS) | 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. | ClinicalTrials.gov |
| Other | Medical Outcomes Study Short Form 36 (SF-36) | 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. | ClinicalTrials.gov |
| Other | Insomnia Severity Index (ISI) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 9
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Iowa Gambling Lite | Primary outcome | ConductCognition |
| Emotional Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)