xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05973214</url>
    </required_header>
    <id_info>
      <org_study_id>C22-19</org_study_id>
      <secondary_id>2022-A01370-43</secondary_id>
      <nct_id>NCT05973214</nct_id>
    </id_info>
    <brief_title>Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)</brief_title>
    <acronym>BELIEFS</acronym>
    <official_title>Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Idiopathic Environmental Intolerance (IEI) denotes a functional disorder represented by&#xD;
        heterogeneous symptoms that sufferers attribute to specific environmental agents and for&#xD;
        which there may be no solid evidence of an underlying physiological cause.&#xD;
  &#xD;
        We are conducting a randomized controlled trial study to compare patients before and after a&#xD;
        newly developed cognitive behavioral therapy treatment program for IEI, with respect to&#xD;
        behavioral and psychometric variables.&#xD;
  &#xD;
        The results of this research project are expected to contribute to advancements in the&#xD;
        clinical treatment of IEI, as well as to elaborate on existing theoretical models of IEI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction:&#xD;
  &#xD;
        A percentage of the population report various, nonspecific somatic and cognitive symptoms&#xD;
        (e.g., headaches, nausea, fatigue, difficulty concentrating...) that they causally attribute&#xD;
        to agents in their environments (chemicals, electromagnetic fields, windmills..). This&#xD;
        condition is called Idiopathic Environmental Intolerance (IEI). It is proposed that the&#xD;
        attribution of symptoms to an environmental agent, and the associated negative expectations&#xD;
        is what drives symptom experience. We hypothesize that this, alongside other cognitive&#xD;
        biases, are involved in the emergence and maintenance of symptoms. Treatment models have been&#xD;
        developed, but no cognitive behavioral therapy was tested on IEI patients.&#xD;
  &#xD;
        The planned study aims to investigate the feasibility and efficacy of a cognitive behavioral&#xD;
        treatment online program, in ameliorating quality of life in a French population of patients&#xD;
        suffering from IEI.&#xD;
  &#xD;
        Methods and analysis:&#xD;
  &#xD;
        This parallel two-armed, randomized controlled trial, evaluates an 8-week guided intervention&#xD;
        against a wait-list control group. It is a hybrid intervention that will include web-based&#xD;
        consecutive modules based on disorder-specific cognitive behavioral therapy (CBT) as well as&#xD;
        general transdiagnostic principles . Guidance will be provided by trained psychologists with&#xD;
        weekly supportive feedback.&#xD;
  &#xD;
        As part of the &quot;BELIEF&quot; project, the present study aims to recruit n=82 patients indicating&#xD;
        symptom attributed to factors in the environment. Assessments will take place at baseline and&#xD;
        after intervention completion (12 and 24 weeks after randomization). The primary outcome will&#xD;
        be measured by the SF-12 scale for quality of life. Secondary outcomes include symptom&#xD;
        perception, severity and distress, eco-anxiety, emotional processing, intolerance to&#xD;
        uncertainty and associated mental disorders such as depression and anxiety. Consumption of&#xD;
        healthcare services will also be measured.&#xD;
  &#xD;
        Ethics and dissemination:&#xD;
  &#xD;
        Ethics approval has been granted. Results from this study will be published in peer-reviewed&#xD;
        journals and presented at international conferences.&#xD;
  &#xD;
        Trial registration number: DRKS00014375&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel two-armed randomized controlled study with a waitlist control group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>SF-12</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Quality of Life</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PHQ15</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SSD12</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Symptom Burden</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SIQ</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Symptom Interpretation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CSS-SHR</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Chemical Sensitivity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EMFSS-11</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Sensitivity to Electromagnetic Fields</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MHWS12</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Modern Health Worries</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CAS</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Climate Change Anxiety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HAD</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Depression and Anxiety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IU</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Intolerance to Uncertainty</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BPQ12</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Interoceptive Accuracy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LEAS</measure>
      <time_frame>T0; 3 Months ; 6 Months</time_frame>
      <description>Emotional Awareness</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">82</enrollment>
    <condition>Idiopathic Environmental Intolerance</condition>
    <arm_group>
      <arm_group_label>Treatment Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Behavioral Therapy</intervention_name>
      <description>CBT for IEI</description>
      <arm_group_label>Treatment Group</arm_group_label>
      <arm_group_label>Waitlist Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged ≥18 years,&#xD;
  &#xD;
            -  Present a diagnosis of idiopathic environmental intolerance confirmed by the lead&#xD;
               psychiatrist at the admission&#xD;
  &#xD;
            -  Be affiliated to a social security regime.&#xD;
  &#xD;
            -  SF-12 SCORE ≤50&#xD;
  &#xD;
            -  Informed Consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe depression, delusion disorder or substance use disorder&#xD;
  &#xD;
            -  No access to internet&#xD;
  &#xD;
            -  Non-French speakers&#xD;
  &#xD;
            -  Currently participating to another research on IEI&#xD;
  &#xD;
            -  Under an exclusion period for another study&#xD;
  &#xD;
            -  Benefiting from French state aid known as AME&#xD;
  &#xD;
            -  Deprivation of liberty by court or administrative order&#xD;
  &#xD;
            -  Hospitalized without consent&#xD;
  &#xD;
            -  Under protective measures&#xD;
  &#xD;
            -  Pregnancy and/or breastfeeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cedric Lemogne, PR, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institut de Psychiatrie et des Neurosciences de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Victor Pitron, MD, PHD</last_name>
      <phone>0142348608</phone>
      <email>victor.pitron@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ingrid Zablith</last_name>
      <phone>0142342608</phone>
      <email>ingrid.zablith@inserm.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Unité de pathologies professionnelles et environnementales, Hôtel-Dieu</name>
        <address>
          <city>Paris</city>
          <zip>75004</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Victor Pitron, MD, PhD</last_name>
        <email>victor.pitron@aphp.fr</email>
      </contact>
      <contact_backup>
        <last_name>Ingrid Zablith</last_name>
        <email>ingrid.zablith@inserm.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Cédric Lemogne, MD,PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Environmental health</keyword>
    <keyword>Idiopathic Environmental Intolerance</keyword>
    <keyword>Cognitive Behavioral Therapy</keyword>
    <keyword>Functional Disorder</keyword>
    <keyword>Somatic Symptoms</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Chemical Sensitivity</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05973214
  org study id: C22-19
  secondary id: 2022-A01370-43
  nct id: NCT05973214
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel two-armed randomized controlled study with a waitlist control group.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: SF-12
  time frame: T0; 3 Months ; 6 Months
  description: Quality of Life
  measure: PHQ15
  time frame: T0; 3 Months ; 6 Months
  description: Symptoms
  measure: SSD12
  time frame: T0; 3 Months ; 6 Months
  description: Symptom Burden
  measure: SIQ
  time frame: T0; 3 Months ; 6 Months
  description: Symptom Interpretation
  measure: CSS-SHR
  time frame: T0; 3 Months ; 6 Months
  description: Chemical Sensitivity
  measure: EMFSS-11
  time frame: T0; 3 Months ; 6 Months
  description: Sensitivity to Electromagnetic Fields
  measure: MHWS12
  time frame: T0; 3 Months ; 6 Months
  description: Modern Health Worries
  measure: CAS
  time frame: T0; 3 Months ; 6 Months
  description: Climate Change Anxiety
  measure: HAD
  time frame: T0; 3 Months ; 6 Months
  description: Depression and Anxiety
  measure: IU
  time frame: T0; 3 Months ; 6 Months
  description: Intolerance to Uncertainty
  measure: BPQ12
  time frame: T0; 3 Months ; 6 Months
  description: Interoceptive Accuracy
  measure: LEAS
  time frame: T0; 3 Months ; 6 Months
  description: Emotional Awareness
  arm group label: Treatment Group
  arm group type: Experimental
  arm group label: Waitlist Control Group
  arm group type: Other
  intervention type: Behavioral
  intervention name: Cognitive Behavioral Therapy
  description: CBT for IEI
  arm group label: Treatment Group
  arm group label: Waitlist Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cedric Lemogne, PR, MD
  role: Principal Investigator
  affiliation: Institut de Psychiatrie et des Neurosciences de Paris
  last name: Victor Pitron, MD, PHD
  phone: 0142348608
  email: victor.pitron@aphp.fr
  last name: Ingrid Zablith
  phone: 0142342608
  email: ingrid.zablith@inserm.fr
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Multiple Chemical Sensitivity