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Healthy VolunteersBELIEFS VSNCT06800976

Study of Cognitive and Behavioural Biases in People With Idiopathic Environmental Intolerance (IEI) Versus Healthy Controls

An observational study of Healthy Volunteers and Idiopathic Environmental Intolerance, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Symptoms that patients attribute to the environment when no environmental cause can be identified are known as "idiopathic environmental intolerance" (IEI). IEI is often associated with a major psychological and socio-professional impact. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
69 participants
Where
1 siteFrance
Study dates
24 Feb 2025to 17 Jun 2025
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: We are recruiting healthy participants that will be age- and gender-matched to participants in the BELIEFS study, who live with idiopathic environmental intolerances.

Who may be able to join

  • 18 years of age or older; not suffering from an idiopathic environmental intolerance; informed consent is given.

Who cannot join

  • Suffering from a current psychiatric or neurological condition
  • not being fluent in spoken and written French
  • person subject to a period of exclusion for other research
  • being imprisoned/jailed
  • being hospitalized
  • Persons of legal age who are subject to a legal protection measure (e.g. conservatorship, guardianship), persons of legal age who are unable to express their consent and who are not subject to a protection measure.
  • being pregnant or breast-feeding
  • Translated with DeepL.com (free version)

Trial locations and contacts

1 site in 1 country.

France1 site
  • Unité de pathologies professionnelles et environnementales, Hôtel-Dieu

    Paris, Île-de-France Region, 75004

Other trials in France

About this study

Symptoms that patients attribute to the environment when no environmental cause can be identified are known as "idiopathic environmental intolerance" (IEI). IEI is often associated with a major psychological and socio-professional impact. Specific diagnostic tools and evidence-based treatment programs are still lacking. As a result, IEI patients often feel left behind by physicians and public health policies.

A number of environmental agents are singled out by IEI sufferers, including chemicals (cleaning products, tobacco smoke), electromagnetic fields generated by cell phones and base stations, air conditioning and infrasound emitted by wind turbines. Patients hold one or more of these environmental agents responsible for a very wide range of chronic, non-specific physical symptoms such as diffuse pain, fatigue, dizziness, dyspnoea, hot flushes, nausea, tinnitus or palpitations, but also cognitive symptoms such as loss of memory or concentration. However, the medical examination of IEI patients shows no evidence of bodily dysfunction.

Read more

Furthermore, numerous exposure studies have shown that environmental agents did not alter the biological parameters of IEI patients, that patients could not reliably distinguish between real and fictitious exposures, and that they only presented symptoms when they thought the exposure was real, whether this was true or not. This suggests that IEI symptoms can be considered "functional", resulting from an alteration in the way the body is felt rather than from injury to the body itself. Recently, several authors including Lemogne and Pitron have proposed a cognitive model of body awareness and more specifically of functional physical symptoms.This model is part of a Bayesian understanding of brain function, which is increasingly seen as a process underlying all perceptual experiences.From this perspective, bodily experiences are the result of probabilistic calculations Two sources of information are integrated, weighted by their reliability (accuracy) with regard to the current context: the body's sensory signals on the one hand (i.e. peripheral nerve inputs) and "priors" about the body on the other (i.e. pre-existing information from previous bodily experiences, beliefs about the body, emotions, etc.). In functional physical symptoms, it has been suggested that priors override the body's sensory signals, thus skewing bodily perception.This would be the consequence of an imbalance between low-precision sensory signals on the one hand, and high-precision priors on the other.

In line with this model, Van den Bergh and Witthöft have proposed an understanding of IEI as arising from a nocebo effect.Here, we propose a research project with patients suffering from IEI to test and validate this Bayesian theoretical model of IEI, the main study C22-19, BELIEFS which is currently recruiting.

This ancillary study, C24-26 BELIEFS-VS, enables us to include a population of healthy volunteers whom we will compare with the IEI patients in the main C22-19 BELIEFS study.

Read the detailed description

In the main BELIEFS study (ClinicalTrials ID NCT05973214), we are investigating the efficacy of a dedicated CBT treatment program for people with IEI, and the evolution of cognitive biases before versus after the treatment program. The present BELIEFS-VS ancillary study aims to include a group of healthy volunteers in order to compare cognitive outcomes in people with IEI. This BELIEFS-VS ancillary study will enable us to better study the cognitive characteristics of IEI patients in comparison with non-affected individuals, and thus gain a better understanding of the pathophysiology of the condition.

Methods and Analysis:

This is an observational study. Healthy controls will be age- and gender-matched to IEI patients. The healthy controls will be invited to one in-person session in our facilities, where they will be asked to fill in some questionnaires and complete some tasks (the Affective Picture Paradigm and the Belief Updating Task).

Ethics and dissemination:

Ethics approval has been granted. Results from this study will be published in peer-reviewed journals and presented at international conferences.

Keywords
predictive processing, Mechanisms, symptoms associated with environmental factors, negative affect
Medical subject headings
Multiple Chemical Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06800976
Study groupRoleWhat they receive
HealthyHealthy participants with no idiopathic environmental intolerance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance on the Belief Updating Task

    Measured: (Single assessment)

  2. Performance on the Affective Picture Paradigm

    Measured: (Single assessment)

Secondary outcomes (10)
  1. The Somatic Symptom Disorder - B Criteria Scale

    Measures the B criterion for Somatic Symptom Disorder (SSD) and symptom burden: The total score ranges between 0 and 48, with a higher score reflecting higher levels of the psychological features of the SSD, or worse outcome.

    Measured: (Single Assessment)

  2. Symptom Interpretation Questionnaire

    Measures causal attributions individuals make of common somatic symptoms by using three sub scales: somatic (range 13-36), psychological (range: 13-52), and environmental/normalizing (range: 17-49). Each sub score represents the extent with which each sub scale is endorsed as a possible cause for symptoms (higher score means higher outcome).

    Measured: (Single Assessment)

  3. Modern Health Worries Scale short (12-item) version

    Measures Modern Health Worries (concerns of respondents about modern environmental issues/threats of modernity). Scores range from 12 to 60 with higher scores indicating more concern or worse outcome.

    Measured: (Single Assessment)

  4. Climate Change Anxiety Scale

    Measures Climate Change Anxiety with scores ranging from 13 to 65 and higher scores indicating higher levels of climate change anxiety, or worse outcome.

    Measured: (Single Assessment)

  5. Hospital Anxiety and Depression scale

    Measures Depression and Anxiety. Score ranges from 0 to 21 per subscale with higher score representing worse outcome.

    Measured: (Single Assessment)

  6. Short Form Health Survey - 12

    Measures quality of life with a minimum value of zero and a maximum value of 100. Higher score indicates better outcome.

    Measured: (Single Assessment)

  7. Body Perception Questionnaire - Very Short Form

    Measures body awareness and autonomic stress response patterns. Scores range from 12 to 60. Particularly high scores may indicate the autonomic nervous system is frequently activated by stress or chronic threat responses (i.e. worse outcome)

    Measured: (Single Assessment)

  8. Levels of Emotional Awareness Scale 10 item

    Measures the Level of Emotional Awareness with a maximum score of 50. Higher scores indicating greater awareness and differentiation in emotions, or better outcome.

    Measured: (Single Assessment)

  9. Short version of the Intolerance of Uncertainty Scale

    Measures Intolerance to Uncertainty with total scores ranging from 12 to 60 with higher score representing worse outcome. The total scores encompasses two sub-scales: prospective anxiety and inhibitory anxiety. A greater score in each subscale indicates a greater level of prospective anxiety and inhibitory anxiety.

    Measured: (Single Assessment)

  10. Number and intensity of physical symptoms - QEESI (subsection symptoms)

    This subscales measures various physical symptoms one might experience in everyday life. Participants can score between 0 and 100 points, with a higher score indication more and more intense symptoms (worse outcome).

    Measured: (Single Assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2025
  2. Study start24 Feb 2025
  3. Primary completion17 Jun 2025
  4. Study completion17 Jun 2025

Resources

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
Prospective
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06800976
Sponsor's protocol ID
C24-26
Acronym
BELIEFS VS
Status last verified
Jul 2026
First submitted
24 Jan 2025
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers and Idiopathic Environmental Intolerance, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

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 1 inclusion and 8 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: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance on the Belief Updating Task (time frame: (Single assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Jul 2026.

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