Effectiveness of a Cognitive and Behavioral Treatment Program in People With Idiopathic Environmental Intolerance (IEI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Short Form Health Survey - 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CBT
干预措施: Cognitive Behavioral Therapy (Behavioral)
Waitlist
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Short Form Health Survey - 12
时间窗: T0; 3 Months ; 6 Months
Measures quality of life with a minimum value of zero and a maximum value of 100. Higher score indicates better outcome.
次要结局
- The Somatic Symptom Disorder - B Criteria Scale(T0; 3 Months ; 6 Months)
- Hospital Anxiety and Depression scale(T0; 3 Months ; 6 Months)
- The Somatic Symptom Disorder - B Criteria Scale(T0; 3 Months ; 6 Months)
- QEESI (Quick environnemental exposure and sensitivity inventory)(T0; 3 Months ; 6 Months)
- Hospital Anxiety and Depression scale(T0; 3 Months ; 6 Months)
- Symptom Interpretation Questionnaire(T0; 3 Months ; 6 Months)
- Climate Change Anxiety Scale(T0; 3 Months ; 6 Months)
- Short version of the Intolerance of Uncertainty Scale(T0; 3 Months ; 6 Months)
- Levels of Emotional Awareness Scale 10 item(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)
- Body Perception Questionnaire - Very Short Form(T0; 3 Months ; 6 Months)