Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Cognitive Behavioral Therapy.
- Кому может быть актуально
- Состояния в реестре: Idiopathic Environmental Intolerance. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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
Вмешательства
- Поведенческое Cognitive Behavioral Therapy
CBT for IEI
Первичные конечные точки
- Short Form Health Survey - 12 [Срок оценки: T0; 3 Months ; 6 Months]
Вторичные конечные точки (10)
- The Somatic Symptom Disorder - B Criteria Scale [Срок оценки: T0; 3 Months ; 6 Months]
- Symptom Interpretation Questionnaire [Срок оценки: T0; 3 Months ; 6 Months]
- QEESI (Quick environnemental exposure and sensitivity inventory) [Срок оценки: T0; 3 Months ; 6 Months]
- 11-item Electromagnetic Field Sensitivity Scale [Срок оценки: T0; 3 Months ; 6 Months]
- Modern Health Worries Scale short (12-item) version [Срок оценки: T0; 3 Months ; 6 Months]
- Climate Change Anxiety Scale [Срок оценки: T0; 3 Months ; 6 Months]
- Hospital Anxiety and Depression scale [Срок оценки: T0; 3 Months ; 6 Months]
- Short version of the Intolerance of Uncertainty Scale [Срок оценки: T0; 3 Months ; 6 Months]
- Body Perception Questionnaire - Very Short Form [Срок оценки: T0; 3 Months ; 6 Months]
- Levels of Emotional Awareness Scale 10 item [Срок оценки: T0; 3 Months ; 6 Months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Франция · 1 центр
- Unité de pathologies professionnelles et environnementales, Hôtel-Dieu — Paris
Публикации
- Pitron V, Petzke T, Zablith I, Revillot-Tirot M, Forestier-Dupuch C, Ibouchna FZ, Witthoft M, Leger D, Bensefa-Colas L, Van den Bergh O, Lemogne C. Efficacy of cognitive and behavioral therapy (CBT) treatment for individuals living with symptoms associated with environmental factors (SAEF): protocol for a randomized controlled trial. BMC Psychol. 2025 Nov 24;13(1):1296. doi: 10.1186/s40359-025-035 PMID 41287001
Идентификаторы
NCT: NCT05973214 · C22-19 · 2022-A01370-43