Interoception in Patients With Medically Unexplained Symptoms

NCT05907538 | Unknown

• 1 other identifier: B1152021000014
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Fibromyalgia; Burnout, Psychological

Keywords

Fibromyalgia; Burnout; Interoception

Outcome Measures

Primary Outcomes (4)

• Interoceptive accuracy

  Respiratory occlusion discrimination task (ROD task; Van Den Houte et al., 2021)

  20 minutes

• Interoceptive sensibility

  Interoceptive Sensitivity and Attention Questionnaire (ISAQ; Bogaerts et al., 2022)

  5 minutes

• Interoceptive sensibility

  THree-domain Interoceptive Sensations Questionnaire (THISQ; Vlemincx et al., 2021)

  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

  5 minutes

Secondary Outcomes (8)

• Psychological variables

  5 minutes

• Psychological variables

  5 minutes

• Psychological variables

  5 minutes

• Psychological variables

  10 minutes

• Psychological variables

  5 minutes

Study Arms (3)

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)

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)

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

Other: Interoceptive accuracy measurement; Other: Interoceptive sensibility measurement; Other: Interoceptive awareness measurement

Interventions

Interoceptive accuracy measurement OTHER

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).

Healthy controls; Patients with functional disorder (FD); Patients with stress related syndromes (SRS)

Interoceptive sensibility measurement OTHER

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)

Healthy controls; Patients with functional disorder (FD); Patients with stress related syndromes (SRS)

Interoceptive awareness measurement OTHER

Interoceptive awareness will be measures using a visual analogue scale (VAS)

Healthy controls; Patients with functional disorder (FD); Patients with stress related syndromes (SRS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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).

You may not qualify if:

• 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)
• \- 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)
• 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
• Healthy controls will be selected so that there is an equal ratio between patients and healthy controls for
• Age group (per 5 years)

Sponsors & Collaborators

• Hasselt University: lead
• TRACE labs Ziekenhuis Oost-Limburg (ZOL): collaborator

Study Sites (2)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

TRACE labs Ziekenhuis Oost-Limburg (ZOL)

Lanaken, 3620, Belgium

RECRUITING

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MeSH Terms

Conditions

Fibromyalgia; Burnout, Psychological

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Katleen Bogaerts, PhD

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Indra Ramakers, Dra

CONTACT

+32483082723; indra.ramakers@uhasselt.be

Marleen Missotten

CONTACT

+32(0)11268502; CME@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 18, 2023
• Study Start: July 25, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

BE (2)