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

Primary Purpose

Idiopathic Environmental Intolerance

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Environmental Intolerance focused on measuring Environmental health, Idiopathic Environmental Intolerance, Cognitive Behavioral Therapy, Functional Disorder, Somatic Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Unité de pathologies professionnelles et environnementales, Hôtel-Dieu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment Group

Waitlist Control Group

Arm Description

Outcomes

Primary Outcome Measures

SF-12
Quality of Life

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2023
Last Updated
July 26, 2023
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT05973214
Brief Title
Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)
Acronym
BELIEFS
Official Title
Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Environmental Intolerance
Keywords
Environmental health, Idiopathic Environmental Intolerance, Cognitive Behavioral Therapy, Functional Disorder, Somatic Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel two-armed randomized controlled study with a waitlist control group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Title
Waitlist Control Group
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
CBT for IEI
Primary Outcome Measure Information:
Title
SF-12
Description
Quality of Life
Time Frame
T0; 3 Months ; 6 Months
Secondary Outcome Measure Information:
Title
PHQ15
Description
Symptoms
Time Frame
T0; 3 Months ; 6 Months
Title
SSD12
Description
Symptom Burden
Time Frame
T0; 3 Months ; 6 Months
Title
SIQ
Description
Symptom Interpretation
Time Frame
T0; 3 Months ; 6 Months
Title
CSS-SHR
Description
Chemical Sensitivity
Time Frame
T0; 3 Months ; 6 Months
Title
EMFSS-11
Description
Sensitivity to Electromagnetic Fields
Time Frame
T0; 3 Months ; 6 Months
Title
MHWS12
Description
Modern Health Worries
Time Frame
T0; 3 Months ; 6 Months
Title
CAS
Description
Climate Change Anxiety
Time Frame
T0; 3 Months ; 6 Months
Title
HAD
Description
Depression and Anxiety
Time Frame
T0; 3 Months ; 6 Months
Title
IU
Description
Intolerance to Uncertainty
Time Frame
T0; 3 Months ; 6 Months
Title
BPQ12
Description
Interoceptive Accuracy
Time Frame
T0; 3 Months ; 6 Months
Title
LEAS
Description
Emotional Awareness
Time Frame
T0; 3 Months ; 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Pitron, MD, PHD
Phone
0142348608
Email
victor.pitron@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Zablith
Phone
0142342608
Email
ingrid.zablith@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cedric Lemogne, PR, MD
Organizational Affiliation
Institut de Psychiatrie et des Neurosciences de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité de pathologies professionnelles et environnementales, Hôtel-Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Pitron, MD, PhD
Email
victor.pitron@aphp.fr
First Name & Middle Initial & Last Name & Degree
Ingrid Zablith
Email
ingrid.zablith@inserm.fr
First Name & Middle Initial & Last Name & Degree
Cédric Lemogne, MD,PhD

12. IPD Sharing Statement

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

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