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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Environmental Intolerance
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

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

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victor Pitron, MD, PHD; Phone Number: 0142348608; Email: victor.pitron@aphp.fr
• Study Contact Backup: Name: Ingrid Zablith; Phone Number: 0142342608; Email: ingrid.zablith@inserm.fr

Study Locations

• France
  • Paris, France, 75004
    • Unité de pathologies professionnelles et environnementales, Hôtel-Dieu
    • Contact: Victor Pitron, MD, PhD; Email: victor.pitron@aphp.fr
    • Contact: Ingrid Zablith; Email: ingrid.zablith@inserm.fr
    • Principal Investigator: Cédric Lemogne, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Waitlist	Behavioral: Cognitive Behavioral Therapy; CBT for IEI
Experimental: CBT	Behavioral: Cognitive Behavioral Therapy; CBT for IEI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	T0; 3 Months ; 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire -15	Measures and monitors somatic symptom with scores ranging from 0 to 30 to represent mild, moderate and severe levels of somatization (higher score represent worst outcomes).	T0; 3 Months ; 6 Months
The Somatic Symptom Disorder - B Criteria Scale	Measures criteria for Somatic Symptom Disorder (SSD) and symptoms' 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.	T0; 3 Months ; 6 Months
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).	T0; 3 Months ; 6 Months
11-item Chemical Sensitivity scale	Measures Chemical Sensitivity. The score can range from 0 to 54 (high score representing high annoyance/intolerance and worse outcome).	T0; 3 Months ; 6 Months
11-item Electromagnetic Field Sensitivity Scale	Measures sensitivity to Electromagnetic Fields. The score can range from 0 to 54 (high score representing high annoyance/intolerance and worse outcome).	T0; 3 Months ; 6 Months
Modern Health Worries Scale short (12-item) version	Measures Modern Health Worries (concerns of respondents about modern environmental issues). Scores range from 12 to 60 with higher scores indicating more concern or worse outcome.	T0; 3 Months ; 6 Months
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.	T0; 3 Months ; 6 Months
Hospital Anxiety and Depression scale	Measures Depression and Anxiety. Score ranges from 0 to 21 with higher score representing worse outcome.	T0; 3 Months ; 6 Months
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.	T0; 3 Months ; 6 Months
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)	T0; 3 Months ; 6 Months
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.	T0; 3 Months ; 6 Months

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Cedric Lemogne, PR, MD, Institut de Psychiatrie et des Neurosciences de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Somatic Symptoms; Environmental health; Idiopathic Environmental Intolerance; Functional Disorder
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Disorders of Environmental Origin; Environmental Illness; Multiple Chemical Sensitivity
• Other Study ID Numbers: C22-19; 2022-A01370-43 (Registry Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No