FibromyalgiaNCT05907538
Interoception in Patients With Medically Unexplained Symptoms
An observational study of Fibromyalgia and Burnout, Psychological, run by Hasselt University at 2 sites in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Burnout, Psychological
- What is being tested?
- Interoceptive accuracy measurement, Interoceptive sensibility measurement and Interoceptive awareness measurement
- How many people
- 84 participants
- Where
- 2 sitesBelgium
- Study dates
- 25 Jul 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- patients with fibromyalgia should be diagnosed by using the ACR criteria (American College of Rheumatology, Wolfe et al., 2010; Wolfe et al., 2016). patients with chronic fatigue syndrome should be diagnosed by using the CDC criteria (Centers for Disease Control and Prevention; Fukuda et al., 1994).
- patients with overstrain or burnout should be diagnosed according to the multidisciplinary guidelines for overstrain and burnout for first-line professionals from the Dutch Society of Occupational Medicine (NVAB, 2011)
- Healthy controls will be selected so that there is an equal ratio between patients and healthy controls for
- Age group (per 5 years)
- Gender (including X)
- Educational attainment
- BMI
- all participants need a score < 75 on the CSD (Walentynowicz, et al., 2018)
Who cannot join
- Younger than 18 or older than 65
- Pregnancy
- Primary depressive episode, anxiety disorder, eating disorder, substance abuse, neurocognitive, or psychotic episode diagnosed with DSM-V (Diagnostic and Statistical Manual of Mental Disorders; MINI-s; Overbeek et al., 1999).
- Presence of a chronic organic disorder (One speaks of a chronic organic disorder if it is present for a period of at least 3 months. Examples include: Epilepsy, Heart Disease, Rheumatism, Asthma, Diabetes, etc.) or acute organic condition (fever, flu, etc.)
- BMI > 30
- Eligibility Criteria patients with SRS (overstrain or burnout)
Show all 18Show fewer
- Younger than 18 or older than 65
- Pregnancy
- Primary depressive episode, anxiety disorder, eating disorder, substance abuse, neurocognitive, or psychotic episode diagnosed with DSM-V (MINI-s; Overbeek et al., 1999).
- Presence of a chronic organic disorder (One speaks of a chronic organic disorder if it is present for a period of at least 3 months. Examples include: Epilepsy, Heart Disease, Rheumatism, Asthma, Diabetes, etc.) or acute organic condition (fever, flu, etc.)
- BMI > 30
- Eligibility Criteria healthy controls
- Younger than 18 or older than 65
- Pregnancy
- Presence of a depressive episode, anxiety disorder, eating disorder, substance abuse, neurocognitive, or psychotic disorder diagnosed with DSM-V (MINI-s; Overbeek et al., 1999).
- Presence of a chronic organic disorder (One speaks of a chronic organic disorder if it is present for a period of at least 3 months. Examples are: epilepsy, heart disease, rheumatism, asthma, diabetes, etc.) or acute organic disorder (fever, flu, etc.)
- BMI > 30
- Persistent physical symptoms (e.g., hyperventilation symptoms, prolonged COVID, chronic pain or fatigue, chronic tinnitus, etc.)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Hasselt University
Diepenbeek, Limburg, 3590
Indra Ramakers, +32483082723, indra.ramakers@uhasselt.be
- Recruiting
TRACE labs Ziekenhuis Oost-Limburg (ZOL)
Lanaken, 3620
Indra Ramakers, +32483082723, indra.ramakers@uhasselt.be
About this study
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:
- Is there a significant difference in interoception between patients with SRS and healthy controls?
- Is there a significant difference in interoception between patients with FD and healthy controls?
- Is there a significant difference in interoception between patients with SRS and FD?
Read more
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia, Burnout, Psychological
- Being tested
- Interoceptive accuracy measurement, Interoceptive sensibility measurement, Interoceptive awareness measurement
- Keywords
- Fibromyalgia, Burnout, Interoception
- Medical subject headings
- Fibromyalgia, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive accuracy measurementOther
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 measurementOther
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 measurementOther
Interoceptive awareness will be measures using a visual analogue scale (VAS)
| Study group | Role | What they receive |
|---|---|---|
| Patients with functional disorder (FD) | 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) Receives: Other: Interoceptive accuracy measurement; Other: Interoceptive sensibility measurement; Other: Interoceptive awareness measurement | |
| Patients with stress related syndromes (SRS) | 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) Receives: Other: Interoceptive accuracy measurement; Other: Interoceptive sensibility measurement; Other: Interoceptive awareness measurement | |
| Healthy controls | 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 Receives: Other: Interoceptive accuracy measurement; Other: Interoceptive sensibility measurement; Other: Interoceptive awareness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interoceptive accuracy
Respiratory occlusion discrimination task (ROD task; Van Den Houte et al., 2021)
Measured: 20 minutes
Interoceptive sensibility
Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022)
Measured: 5 minutes
Interoceptive sensibility
THree-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)
Measured: 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
Measured: 5 minutes
Secondary outcomes (8)
Psychological variables
Checklist for Symptoms in Daily Life (CSD; Walentynowicz et al., 2018)
Measured: 5 minutes
Psychological variables
Positive and Negative Affect Scale (PANAS; Watson et al., 1988)
Measured: 5 minutes
Psychological variables
Tellegen Absorption Scale (TAS; Tellegen \& Atkinson, 1974)
Measured: 5 minutes
Psychological variables
Traumatic Experiences Checklist (TEC; Nijenhuis et al., 2002)
Measured: 10 minutes
Psychological variables
Toronto Alexithymia Scale (TAS-20; Bagby et al., 1994)
Measured: 5 minutes
Psychological variables
Need for Controllability and Predictability Questionnaire (NCP-q; Ramakers et al., manuscript in preparation)
Measured: 5 minutes
Psychological variables
Frost Multidimensional Perfectionism Scale (FMPS; Frost et al., 1990)
Measured: 5 minutes
Psychological variables
Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- TRACE labs Ziekenhuis Oost-Limburg (ZOL)
- Responsible party
- Principal investigator, Indra Ramakers, Hasselt University
- Investigators
- Katleen Bogaerts, PhD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907538
- Sponsor's protocol ID
- B1152021000014
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haller H, Cramer H, Lauche R, Dobos G. Somatoform disorders and medically unexplained symptoms in primary care. Dtsch Arztebl Int. 2015 Apr 17;112(16):279-87. doi: 10.3238/arztebl.2015.0279.
PubMed 25939319Barsky AJ, Borus JF. Functional somatic syndromes. Ann Intern Med. 1999 Jun 1;130(11):910-21. doi: 10.7326/0003-4819-130-11-199906010-00016.
PubMed 10375340Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
PubMed 27916278Walentynowicz, M., Witthöft, M., Raes, F., Van Diest, I., & Van den Bergh, O. (2018). Sensory and affective components of symptom perception: a psychometric approach. Journal of Experimental Psychopathology, 9(2), 1-13. Doi: 10.5127/jep.059716
Courtois I, Cools F, Calsius J. Effectiveness of body awareness interventions in fibromyalgia and chronic fatigue syndrome: a systematic review and meta-analysis. J Bodyw Mov Ther. 2015 Jan;19(1):35-56. doi: 10.1016/j.jbmt.2014.04.003. Epub 2014 Apr 18.
PubMed 25603742NVAB. (2011). Eén lijn in de eerste lijn bij overspanning en burnout: Multidisciplinaire richtlijn overspanning en burnout voor eerstelijns professionals. Geraadpleegd van https://nvab-online.nl/sites/default/files/bestanden-webpaginas/MDRL_Overspanning-Burnout.pdf
Terluin, B., Van der Klink, J., Schaufeli, W. (2005). Stressgerelateerde klachten: spanningsklachten, overspanning en burnout. In J. Van der Klink, B. Terluin B (Reds), Psychische problemen en werk. Handboek voor een activerende begeleiding door huisarts en bedrijfsarts (p. 259-290). Houten: Bohn Stafleu Van Loghum.
van der Klink JJ, van Dijk FJ. Dutch practice guidelines for managing adjustment disorders in occupational and primary health care. Scand J Work Environ Health. 2003 Dec;29(6):478-87. doi: 10.5271/sjweh.756.
PubMed 14712856Khalsa SS, Adolphs R, Cameron OG, Critchley HD, Davenport PW, Feinstein JS, Feusner JD, Garfinkel SN, Lane RD, Mehling WE, Meuret AE, Nemeroff CB, Oppenheimer S, Petzschner FH, Pollatos O, Rhudy JL, Schramm LP, Simmons WK, Stein MB, Stephan KE, Van den Bergh O, Van Diest I, von Leupoldt A, Paulus MP; Interoception Summit 2016 participants. Interoception and Mental Health: A Roadmap. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):501-513. doi: 10.1016/j.bpsc.2017.12.004. Epub 2017 Dec 28.
PubMed 29884281Garfinkel SN, Seth AK, Barrett AB, Suzuki K, Critchley HD. Knowing your own heart: distinguishing interoceptive accuracy from interoceptive awareness. Biol Psychol. 2015 Jan;104:65-74. doi: 10.1016/j.biopsycho.2014.11.004. Epub 2014 Nov 20.
PubMed 25451381Van Den Houte M, Vlemincx E, Franssen M, Van Diest I, Van Oudenhove L, Luminet O. The respiratory occlusion discrimination task: A new paradigm to measure respiratory interoceptive accuracy. Psychophysiology. 2021 Apr;58(4):e13760. doi: 10.1111/psyp.13760. Epub 2021 Jan 12.
PubMed 33438245Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The chronic fatigue syndrome: a comprehensive approach to its definition and study. International Chronic Fatigue Syndrome Study Group. Ann Intern Med. 1994 Dec 15;121(12):953-9. doi: 10.7326/0003-4819-121-12-199412150-00009.
PubMed 7978722Bogaerts K, Walentynowicz M, Van Den Houte M, Constantinou E, Van den Bergh O. The Interoceptive Sensitivity and Attention Questionnaire: Evaluating Aspects of Self-Reported Interoception in Patients With Persistent Somatic Symptoms, Stress-Related Syndromes, and Healthy Controls. Psychosom Med. 2022 Feb-Mar 01;84(2):251-260. doi: 10.1097/PSY.0000000000001038.
PubMed 34840287Vlemincx E, Walentynowicz M, Zamariola G, Van Oudenhove L, Luminet O. A novel self-report scale of interoception: the three-domain interoceptive sensations questionnaire (THISQ). Psychol Health. 2023 Sep-Oct;38(9):1234-1253. doi: 10.1080/08870446.2021.2009479. Epub 2021 Dec 7.
PubMed 34875958
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoception in Patients With Medically Unexplained Symptoms
- ClinicalTrials.gov ID
- NCT05907538
- Acronym / sponsor ID
- B1152021000014
- Conditions
- Fibromyalgia, Burnout, Psychological
- Keywords
- Fibromyalgia, Burnout, Interoception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- TRACE labs Ziekenhuis Oost-Limburg (ZOL)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there a significant difference in interoception between patients with SRS and healthy controls?
- Is there a significant difference in interoception between patients with FD and healthy controls?
- Is there a significant difference in interoception between patients with SRS and FD?
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with functional disorder (FD) | – | Other: Interoceptive accuracy measurement, Other: Interoceptive sensibility measurement, Other: Interoceptive awareness measurementPatients 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) |
| Patients with stress related syndromes (SRS) | – | Other: Interoceptive accuracy measurement, Other: Interoceptive sensibility measurement, Other: Interoceptive awareness measurementPatients 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) |
| Healthy controls | – | Other: Interoceptive accuracy measurement, Other: Interoceptive sensibility measurement, Other: Interoceptive awareness measurementHealthy 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (8 listed)
- patients with fibromyalgia should be diagnosed by using the ACR criteria (American College of Rheumatology, Wolfe et al., 2010; Wolfe et al., 2016). patients with chronic fatigue syndrome should be diagnosed by using the CDC criteria (Centers for Disease Control and Prevention; Fukuda et al., 1994).
- patients with overstrain or burnout should be diagnosed according to the multidisciplinary guidelines for overstrain and burnout for first-line professionals from the Dutch Society of Occupational Medicine (NVAB, 2011)
- Healthy controls will be selected so that there is an equal ratio between patients and healthy controls for
- Age group (per 5 years)
- Gender (including X)
Key exclusion criteria (18 listed)
- Younger than 18 or older than 65
- Pregnancy
- Primary depressive episode, anxiety disorder, eating disorder, substance abuse, neurocognitive, or psychotic episode diagnosed with DSM-V (Diagnostic and Statistical Manual of Mental Disorders; MINI-s; Overbeek et al., 1999).
- Presence of a chronic organic disorder (One speaks of a chronic organic disorder if it is present for a period of at least 3 months. Examples include: Epilepsy, Heart Disease, Rheumatism, Asthma, Diabetes, etc.) or acute organic condition (fever, flu, etc.)
- BMI > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoceptive accuracy measurementInteroceptive 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). | Other | Healthy controls, Patients with functional disorder (FD), Patients with stress related syndromes (SRS) |
| Interoceptive sensibility measurementInteroceptive 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) | Other | Healthy controls, Patients with functional disorder (FD), Patients with stress related syndromes (SRS) |
| Interoceptive awareness measurementInteroceptive awareness will be measures using a visual analogue scale (VAS) | Other | Healthy controls, Patients with functional disorder (FD), Patients with stress related syndromes (SRS) |
Primary outcome
Interoceptive accuracy
Time frame: 20 minutes
Respiratory occlusion discrimination task (ROD task; Van Den Houte et al., 2021)
Interoceptive sensibility
Time frame: 5 minutes
Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022)
Interoceptive sensibility
Time frame: 5 minutes
THree-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)
Interoceptive awareness
Time frame: 5 minutes
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
8 secondary outcomes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 10 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Psychological variables
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 25939319Haller H, Cramer H, Lauche R, Dobos G. Somatoform disorders and medically unexplained symptoms in primary care. Dtsch Arztebl Int. 2015 Apr 17;112(16):279-87. doi: 10.3238/arztebl.2015.0279.
- Background: PubMed 10375340Barsky AJ, Borus JF. Functional somatic syndromes. Ann Intern Med. 1999 Jun 1;130(11):910-21. doi: 10.7326/0003-4819-130-11-199906010-00016.
- Background: PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
- Background: PubMed 27916278Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
- BackgroundWalentynowicz, M., Witthöft, M., Raes, F., Van Diest, I., & Van den Bergh, O. (2018). Sensory and affective components of symptom perception: a psychometric approach. Journal of Experimental Psychopathology, 9(2), 1-13. Doi: 10.5127/jep.059716
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katleen Bogaerts, PhD principal investigator
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Burnout, Psychological, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Indra Ramakers, Dra (+32483082723, indra.ramakers@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interoceptive accuracy (time frame: 20 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907538, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.