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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05973214

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Environmental Intolerance	Behavioral: Cognitive Behavioral Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel two-armed randomized controlled study with a waitlist control group.Parallel two-armed randomized controlled study with a waitlist control group.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment Group

Behavioral: Cognitive Behavioral Therapy

CBT for IEI

Other: Waitlist Control Group

Behavioral: Cognitive Behavioral Therapy

CBT for IEI

Outcome Measures

Primary Outcome Measures

SF-12 [T0; 3 Months ; 6 Months]
Quality of Life

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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