Understanding interoception in patients with unexplained symptoms
Interoception in Patients With Medically Unexplained Symptoms
This study is trying to see how well people with fibromyalgia and chronic fatigue syndrome can sense their body's signals compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hasselt University Academic / other |
| Locations | 2 sites (Diepenbeek, Limburg and 1 other locations) |
| Trial ID | NCT05907538 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate interoception in patients suffering from stress-related syndromes and functional disorders, specifically fibromyalgia and chronic fatigue syndrome. Participants will undergo a respiratory occlusion discrimination task and complete questionnaires to assess their interoceptive abilities. The study will compare the interoceptive accuracy and sensibility of patients with these conditions against healthy controls to identify significant differences. The findings could enhance our understanding of how these patients perceive bodily signals and contribute to better management strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 diagnosed with fibromyalgia or chronic fatigue syndrome.
Not a fit: Patients with primary mental health disorders, chronic organic diseases, or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic approaches for patients with fibromyalgia and chronic fatigue syndrome.
How similar studies have performed: While there is ongoing research into interoception, this specific approach focusing on stress-related syndromes and functional disorders is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria patients with FD (fibromyalgia and/or chronic fatigue syndrome) Inclusion Criteria: * 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). Exclusion Criteria: * 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) Inclusion Criteria: - 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) Exclusion Criteria: * 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 Inclusion Criteria: 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) Exclusion Criteria: * 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.)
Where this trial is running
Diepenbeek, Limburg and 1 other locations
- Hasselt University — Diepenbeek, Limburg, Belgium (Recruiting)
- TRACE labs Ziekenhuis Oost-Limburg (ZOL) — Lanaken, Belgium (Recruiting)
Study contacts
- Principal investigator: Katleen Bogaerts, PhD — Hasselt University
- Study coordinator: Indra Ramakers, Dra
- Email: indra.ramakers@uhasselt.be
- Phone: +32483082723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.