Clinical trial NCT05973214: Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)
Official title: Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Environmental Intolerance
Keywords: Environmental health
Idiopathic Environmental Intolerance
Cognitive Behavioral Therapy
Functional Disorder
Somatic Symptoms
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2023-08-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel two-armed randomized controlled study with a waitlist control group.
Primary purpose: TREATMENT

Brief summary: Idiopathic Environmental Intolerance (IEI) denotes a functional disorder represented by heterogeneous symptoms that sufferers attribute to specific environmental agents and for which there may be no solid evidence of an underlying physiological cause.

We are conducting a randomized controlled trial study to compare patients before and after a newly developed cognitive behavioral therapy treatment program for IEI, with respect to behavioral and psychometric variables.

The results of this research project are expected to contribute to advancements in the clinical treatment of IEI, as well as to elaborate on existing theoretical models of IEI.

Detailed description: Introduction:

A percentage of the population report various, nonspecific somatic and cognitive symptoms (e.g., headaches, nausea, fatigue, difficulty concentrating...) that they causally attribute to agents in their environments (chemicals, electromagnetic fields, windmills..). This condition is called Idiopathic Environmental Intolerance (IEI). It is proposed that the attribution of symptoms to an environmental agent, and the associated negative expectations is what drives symptom experience. We hypothesize that this, alongside other cognitive biases, are involved in the emergence and maintenance of symptoms. Treatment models have been developed, but no cognitive behavioral therapy was tested on IEI patients.

The planned study aims to investigate the feasibility and efficacy of a cognitive behavioral treatment online program, in ameliorating quality of life in a French population of patients suffering from IEI.

Methods and analysis:

This parallel two-armed, randomized controlled trial, evaluates an 8-week guided intervention against a wait-list control group. It is a hybrid intervention that will include web-based consecutive modules based on disorder-specific cognitive behavioral therapy (CBT) as well as general transdiagnostic principles . Guidance will be provided by trained psychologists with weekly supportive feedback.

As part of the "BELIEF" project, the present study aims to recruit n=82 patients indicating symptom attributed to factors in the environment. Assessments will take place at baseline and after intervention completion (12 and 24 weeks after randomization). The primary outcome will be measured by the SF-12 scale for quality of life. Secondary outcomes include symptom perception, severity and distress, eco-anxiety, emotional processing, intolerance to uncertainty and associated mental disorders such as depression and anxiety. Consumption of healthcare services will also be measured.

Ethics and dissemination:

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

Trial registration number: DRKS00014375

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years,
* Present a diagnosis of idiopathic environmental intolerance confirmed by the lead psychiatrist at the admission
* Be affiliated to a social security regime.
* SF-12 SCORE ≤50
* Informed Consent

Exclusion Criteria:

* Severe depression, delusion disorder or substance use disorder
* No access to internet
* Non-French speakers
* Currently participating to another research on IEI
* Under an exclusion period for another study
* Benefiting from French state aid known as AME
* Deprivation of liberty by court or administrative order
* Hospitalized without consent
* Under protective measures
* Pregnancy and/or breastfeeding

Primary outcomes:
measure: Short Form Health Survey - 12
timeFrame: T0; 3 Months ; 6 Months
Secondary outcomes:
measure: Patient Health Questionnaire -15
timeFrame: T0; 3 Months ; 6 Months
measure: The Somatic Symptom Disorder - B Criteria Scale
timeFrame: T0; 3 Months ; 6 Months
measure: Symptom Interpretation Questionnaire
timeFrame: T0; 3 Months ; 6 Months
measure: 11-item Chemical Sensitivity scale
timeFrame: T0; 3 Months ; 6 Months
measure: 11-item Electromagnetic Field Sensitivity Scale
timeFrame: T0; 3 Months ; 6 Months
measure: Modern Health Worries Scale short (12-item) version
timeFrame: T0; 3 Months ; 6 Months
measure: Climate Change Anxiety Scale
timeFrame: T0; 3 Months ; 6 Months
measure: Hospital Anxiety and Depression scale
timeFrame: T0; 3 Months ; 6 Months
measure: Short version of the Intolerance of Uncertainty Scale
timeFrame: T0; 3 Months ; 6 Months
measure: Body Perception Questionnaire - Very Short Form
timeFrame: T0; 3 Months ; 6 Months
measure: Levels of Emotional Awareness Scale 10 item
timeFrame: T0; 3 Months ; 6 Months
Other outcomes:
Locations:
city: Paris
country: France
facility: Unité de pathologies professionnelles et environnementales, Hôtel-Dieu
Study officials:
affiliation: Institut de Psychiatrie et des Neurosciences de Paris
name: Cedric Lemogne, PR, MD
role: PRINCIPAL_INVESTIGATOR
References: