NCT05973214

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Feb 2024Nov 2028

First Submitted

Initial submission to the registry

July 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

July 26, 2023

Last Update Submit

August 7, 2025

Conditions

Idiopathic Environmental Intolerance

Keywords

Environmental healthIdiopathic Environmental IntoleranceCognitive Behavioral TherapyFunctional DisorderSomatic Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • The Somatic Symptom Disorder - B Criteria Scale

    T0; 3 Months ; 6 Months

  • Symptom Interpretation Questionnaire

    T0; 3 Months ; 6 Months

  • QEESI (Quick environnemental exposure and sensitivity inventory)

    T0; 3 Months ; 6 Months

  • 11-item Electromagnetic Field Sensitivity Scale

    T0; 3 Months ; 6 Months

  • Modern Health Worries Scale short (12-item) version

    T0; 3 Months ; 6 Months

  • +5 more secondary outcomes

Other Outcomes (7)

  • Attitudes Towards Seeking Mental Health Services Inventory (IASMHS)

    T0

  • healthcare utilization questionnaire

    T0, 3 months, 6 months

  • Working Alliance Inventory

    filled out after 3 weeks into treatment by the therapist.

  • +4 more other outcomes

Study Arms (2)

CBT

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy

Waitlist

OTHER
Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

CBT for IEI

CBTWaitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18 years,
  • Present a diagnosis of idiopathic environmental intolerance confirmed by the lead physician at the admission
  • Be affiliated to a social security regime.
  • Informed Consent

You may not qualify if:

  • Severe depression, delusion disorder or substance use disorder
  • No access to internet
  • Non-French speakers
  • Currently participating to another research on IEI
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de pathologies professionnelles et environnementales, Hôtel-Dieu

Paris, Paris, 75004, France

RECRUITING

MeSH Terms

Conditions

Multiple Chemical SensitivityMedically Unexplained Symptoms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Environmental IllnessHypersensitivityImmune System DiseasesDisorders of Environmental OriginSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cedric Lemogne, PR, MD

    Institut de Psychiatrie et des Neurosciences de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Pitron, MD, PHD

CONTACT

0142348608victor.pitron@aphp.fr

Ingrid Zablith

CONTACT

0142342608ingrid.zablith@inserm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel two-armed randomized controlled study with a waitlist control group.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 2, 2023

Study Start

February 20, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations

FR(1)