Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score.
研究概览
简要总结
This study evaluates a mindfulness intervention in patients with drug resistant epilepsy.
Half of participants will follow a mindfulness programme, while the other half will follow a self management programme.
详细描述
Drug-resistant epilepsy is associated with an alteration of the quality of life mainly related to psychiatric comorbidities (anxiety and depression). The management of these comorbidities is therefore essential in patients with drug resistant epilepsy, Ideally through non-drug management to minimize the side effects of molecules.
The goal of mindfulness interventions in pathology is to learn to better live with a chronic disease by reducing the stress resulting from the disease, by increasing benevolence towards oneself, the acceptance of the disease and reducing the ruminations linked with the pathology.
Mindfulness therefore seems to be a good way for these patients to improve the management of their emotions and thus improve their quality of life what the investigators propose to evaluate in this study.
The study consists of two phases
- First phase: comparative randomized study (primary endpoint):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Drug resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE)
- •Stable therapy for at least 3 months
- •No planned surgery
- •Patient affiliated to social security insurance or beneficiary of social security insurance.
- •Signed consent
排除标准
- •Patient who has previously had or regularly practicing mindfulness
- •Patient with psychogenic non-epileptic seizures
- •Pregnant woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to legal protection
- •Patient with relationship disorders related to psychosis
- •Patients who are unable or unwilling to work as a group or person unable to understand the topics discussed during session.
结局指标
主要结局
Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score.
时间窗: 9 months
The QOLIE31-P questionnaire has been developed specifically to measure the quality of life of patients with epilepsy. The score ranges from 0 to 100 points. Higher scores reflect better quality of life; lower ones, worse quality of life. The score of QOLIE31-P will be assess prior to intervention and then at month 3, month 6 and month 9 after the beginning of the intervention. Ref : Cramer JA. Van Hammee G. N132 Study Group. Maintenance of improvement in health-related quality of life during long-term treatment with levetiracetam. Epilepsy \& Behavior 2003; 4:118-123.
次要结局
- Evolution of anxiety level(9 months)
- Evolution of stress management(9 months)
- Evolution of seizures frequency(9 months)
- Evolution of psychiatric morbidity(9 months)
- Evolution of stress level(9 months)
- Evolution of cognitive functions(9 months)
- Evolution of self acceptance and interoception(9 months)