An observational study in Fibromyalgia and Burnout, Psychological, sponsored by Hasselt University. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Hasselt University · Observational
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Among 23 studies in Fibromyalgia with a site in Belgium — 7 open to participants now, 7 under way, none of them phase 3. Fibromyalgia · Belgium.
Among the 23 studies in Fibromyalgia with a site in Belgium, this one is one of 3 that started in 2022, is one of 9 observational ones, and was the 17th registered.
1,243 studies on the registry are indexed under Fibromyalgia; 255 are open to participants now.
Browse Fibromyalgia studies →7 of the 23 studies in Fibromyalgia with a site in Belgium are open now. Recruiting first, the newest first:
Vrije Universiteit Brussel · Sites in Belgium
Ages 18–70 · Healthy volunteers
Universitair Ziekenhuis Brussel · Sites in Belgium
Ages 18+
Vrije Universiteit Brussel · Sites in Belgium
Ages 18+ · Healthy volunteers
Hasselt University · Sites in Belgium
Ages 18–65 · Healthy volunteers
University Ghent · Sites in Belgium
Ages 18–65 · Healthy volunteers
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 3 · Phase 3 2
First in 2004; this study’s year is marked. 3 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 84 is below the median of 100 across 279 observational studies indexed under Fibromyalgia.
Median enrollment 60 across the 13 interventional studies, 100 across the 9 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 23 have an industry lead sponsor. The 10 most frequent:
Hasselt University is the lead sponsor of 204 studies on the registry; 31 are open to participants now.
Hasselt University has 2 studies filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
2 of the studies in Fibromyalgia with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06892977University GhentMapping Stress and Pain Interactions (G072323N) | 2026-12 |
| NCT07176078Universitair Ziekenhuis BrusselEvaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome | 2026-12 |
Add all 2 to your calendar (.ics) → With an account.
Among the 23 studies in Fibromyalgia with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The goal of this observational study is to learn about interoception in patients with stress related syndromes (overstrain, burnout; SRS) and functional disorder (fibromyalgia/ chronic fatigue syndrome; FD). The main questions it aims to answer are:
The participants will perform the respiratory occlusion discrimination task and have to fill out some questionnaires.
Researchers will compare healthy controls to see if there is a significant difference.
About 40-49% of primary care patients report somatic symptoms that cannot be explained by any well-known organic disease. Typical examples are headache, dizziness, shortness of breath, fatigue, muscle aches, nausea, and gastrointestinal symptoms. These bodily symptoms can occur in the context of SRS such as overstrain and burnout, but also as clusters in a more chronic form, often referred to as FD, such as fibromyalgia or chronic fatigue syndrome.
Fibromyalgia is a chronic widespread pain condition characterized by point tenderness, fatigue, sleep disturbance, cognitive complaints, and increasing somatic complaints. In addition, chronic fatigue syndrome is a chronic condition characterized by severe fatigue, impairments in concentration and short-term memory, sleep disturbance, and musculoskeletal pain. Both are multi-faceted and challenging chronic conditions with considerable overlap in symptoms, causes and treatments. According to multidisciplinary guidelines, overstrain is characterized by the following symptoms: disturbed or restless sleep, irritability, not being able to stand commotion/ noise, emotional lability, feeling stressed or rushed, not being able to relax, difficulty concentrating and/or forgetfulness with a duration of 3 months. Burnout occurs when symptoms of overstrain persist for more than 6 months, and feelings of fatigue and exhaustion become prominent. The patient experiences significant limitations in professional and/or social functioning.
Interoception has been described in the literature as "the overall process of how the nervous system senses, integrates, stores and displays information about the state of the internal body". Theory suggests that interoception should be divided into three measurable constructs: interoceptive accuracy (objective accuracy in detecting internal bodily sensations), interoceptive sensitivity (the self-perceived tendency to be internally self-focused), and interoceptive awareness (metacognition about his/her own interoceptive accuracy).
The measurement will take place in the TRACE labs of Ziekenhuis Oost Limburg (ZOL). The informed consent will be signed before any data collection takes place. The experiment will take approximately 30 minutes. Participants will start with the interoceptive accuracy task using the Respiratory Occlusion Discrimination Task (ROD task). The ROD task measures how good subjects are at distinguishing the lengths of short (max 620 ms) inspiratory occlusions (or respiratory interruptions). Occlusions of these lengths are not aversive or unpleasant. One trial consists of two occlusions within one inspiration (inter-occlusion interval = 300 milliseconds), one occlusion being the reference occlusion (always 440 milliseconds) and one occlusion being the test occlusion (longer or shorter than 440 milliseconds), administered in random order. The participant is asked to indicate which of the two occlusions was longest. An adaptive staircase paradigm is used to determine the just noticeable difference in lengths of inspiratory occlusions. The length of the task depends on the performance of the subject, but is on average 56 trials (= 15 minutes). After the experiment, another short side experiment of 16 trials will be conducted in which the participant should indicate how confident they were in their response on a Visual Analogue scale (VAS), in order to estimate interoceptive awareness. In the meantime, participants will be also asked to complete a questionnaire bundle at home (online), which takes approximately 45 minutes to complete.
The power calculations resulted in a total of 28 persons per group. Therefore the investigators plan to recruit a total of 84 people.
Primary outcomes are interoceptive accuracy, interoceptive sensibility, and interoceptive awareness. Secondary outcome measures are psychological variables measured using questionnaires.
Descriptive statistics will be used to display baseline group characteristics. To evaluate between-group differences (i.e. the difference between patients with FD,SRS and healthy controls regarding interoception and psychological variables) one-way ANOVA's will be used.
All patients with fibromyalgia diagnosed according to the ACR criteria (Wolfe et al., 2010; 2016) are eligible to participate, all patients with chronic fatigue syndrome diagnosed according to the CDC criteria (Fukuda et al., 1994), and all patients with overstrain or burnout diagnosed according to the multidisciplinary guidelines for overstrain and burnout for first-line professionals from the Dutch Society of Occupational Medicine (NVAB, 2011) are eligible to participate
Eligibility Criteria patients with FD (fibromyalgia and/or chronic fatigue syndrome)
Inclusion Criteria:
Exclusion Criteria:
Eligibility Criteria patients with SRS (overstrain or burnout)
Inclusion Criteria:
Exclusion Criteria:
Eligibility Criteria healthy controls
Inclusion Criteria:
Healthy controls will be selected so that there is an equal ratio between patients and healthy controls for
all participants need a score \< 75 on the CSD (Walentynowicz, et al., 2018)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with fibromyalgia diagnosed using the ACR criteria (American College of Rheumatology, Wolfe et al., 2010; 2016) Patients with chronic fatigue syndrome diagnosed using the CDC criteria (Centers for Disease Control and Prevention; Fukuda et al., 1994)
Other: Interoceptive accuracy measurement · Other: Interoceptive sensibility measurement · Other: Interoceptive awareness measurement
Patients with overstrain and burnout according to the multidisciplinary guidelines for overstrain and burnout in primary care from the Dutch Society of Occupational Medicine (NVAB, 2011)
Other: Interoceptive accuracy measurement · Other: Interoceptive sensibility measurement · Other: Interoceptive awareness measurement
Healthy controls will consist of people who experience few physical complaints in daily life. The healthy controls will thus be screened for inclusion using the CSD (Checklist for Symptoms in Daily life; Walentynowicz, et al., 2018). Only volunteers with a score of 75 or lower on this questionnaire will be included
Other: Interoceptive accuracy measurement · Other: Interoceptive sensibility measurement · Other: Interoceptive awareness measurement
Interoceptive accuracy will be measured using the Respiratory Occlusion Discrimination Task (ROD task; Van Den Houte et al., 2021). The ROD task measures how good subjects are at distinguishing the lengths of short (max 620 milliseconds) inspiratory occlusions (or respiratory interruptions).
Interoceptive sensibility will be measured using two self-report questionnaires, the The Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022) and the the Three-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)
Interoceptive awareness will be measures using a visual analogue scale (VAS)
Interoceptive accuracy
Respiratory occlusion discrimination task (ROD task; Van Den Houte et al., 2021)
Time frame: 20 minutes
Interoceptive sensibility
Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022)
Time frame: 5 minutes
Interoceptive sensibility
THree-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)
Time frame: 5 minutes
Interoceptive awareness
Visual analogue scale (0-100). A score of 0 indicates that participants are not certain at all of their answer, a score of 100 indicates that participants are entirely certain of their answer
Time frame: 5 minutes
Psychological variables
Checklist for Symptoms in Daily Life (CSD; Walentynowicz et al., 2018)
Time frame: 5 minutes
Psychological variables
Positive and Negative Affect Scale (PANAS; Watson et al., 1988)
Time frame: 5 minutes
Psychological variables
Tellegen Absorption Scale (TAS; Tellegen \& Atkinson, 1974)
Time frame: 5 minutes
Psychological variables
Traumatic Experiences Checklist (TEC; Nijenhuis et al., 2002)
Time frame: 10 minutes
Psychological variables
Toronto Alexithymia Scale (TAS-20; Bagby et al., 1994)
Time frame: 5 minutes
Psychological variables
Need for Controllability and Predictability Questionnaire (NCP-q; Ramakers et al., manuscript in preparation)
Time frame: 5 minutes
Psychological variables
Frost Multidimensional Perfectionism Scale (FMPS; Frost et al., 1990)
Time frame: 5 minutes
Psychological variables
Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011)
Time frame: 5 minutes
Started Jul 2022 (actual). Primary completion is estimated for Jun 2024, 23 months after the start.
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