Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)

Study Overview
=================
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

Official Title
-----------------
Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)

Conditions
-----------------
Idiopathic Environmental Intolerance

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel two-armed randomized controlled study with a waitlist control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Behavioral: Cognitive Behavioral Therapy<br>* CBT for IEI<br>|
| Other: Waitlist Control Group<br> | Behavioral: Cognitive Behavioral Therapy<br>* CBT for IEI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 | Quality of Life | T0; 3 Months ; 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ15 | Symptoms | T0; 3 Months ; 6 Months | 
| SSD12 | Symptom Burden | T0; 3 Months ; 6 Months | 
| SIQ | Symptom Interpretation | T0; 3 Months ; 6 Months | 
| CSS-SHR | Chemical Sensitivity | T0; 3 Months ; 6 Months | 
| EMFSS-11 | Sensitivity to Electromagnetic Fields | T0; 3 Months ; 6 Months | 
| MHWS12 | Modern Health Worries | T0; 3 Months ; 6 Months | 
| CAS | Climate Change Anxiety | T0; 3 Months ; 6 Months | 
| HAD | Depression and Anxiety | T0; 3 Months ; 6 Months | 
| IU | Intolerance to Uncertainty | T0; 3 Months ; 6 Months | 
| BPQ12 | Interoceptive Accuracy | T0; 3 Months ; 6 Months | 
| LEAS | Emotional Awareness | T0; 3 Months ; 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Environmental health, Idiopathic Environmental Intolerance, Cognitive Behavioral Therapy, Functional Disorder, Somatic Symptoms