Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
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: mindfulness intervention, psycho educative programme.
- Кому может быть актуально
- Состояния в реестре: Drug Resistant Epilepsy. 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
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.
Подробное описание
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
1. First phase: comparative randomized study (primary endpoint):
1. After inclusion, a 2 months baseline follow-up is carry to collect the judgement criteria without intervention. 2. At the end of this period, patients will be randomly assigned to the mindfulness intervention group or the control group with the psycho educative programme. Both programmes will takes 3 months. 3. Then a 6-months post-intervention follow-up period for both groups
Patients will have assessment visits every 3 months. They will also complete a daily notebook including the number of seizures they have done and a scale of their "interior weather". 2. Second phase (optional):
At the end of the first phase, patients in the control group will be able to benefit from the mindfulness programme and will be followed at the end of the programme for 6 months.
Вмешательства
- Другое mindfulness intervention
The mindfulness program is conducted in a group session of up to 10 people. Each session lasts 2 hours. A total of 12 sessions will be conducted by a practitioner who is specifically trained in this type of programme. - Другое psycho educative programme
The psycho-educational control intervention will follow the same format and structure as the mindfulness meditation intervention in terms of group format, session duration and frequency. This is a therapeutic education programme developed for several years in the neurology department of the university hospital of Lyon and Grenoble. The program follows the repository recommended by the french league against epilepsy.
Первичные конечные точки
- Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score. [Срок оценки: 9 months]
Вторичные конечные точки (9)
- Evolution of seizures frequency [Срок оценки: 9 months]
- Evolution of psychiatric morbidity [Срок оценки: 9 months]
- Evolution of anxiety level [Срок оценки: 9 months]
- Evolution of stress management [Срок оценки: 9 months]
- Evolution of stress level [Срок оценки: 9 months]
- Evolution of self acceptance and interoception [Срок оценки: 9 months]
- Evolution of self acceptance and interoception [Срок оценки: 9 months]
- Evolution of self acceptance and interoception [Срок оценки: 9 months]
- Evolution of cognitive functions [Срок оценки: 9 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
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
- Открытое
- Основная цель
- Другое
Центры проведения
Франция · 3 центра
- Epileptology Department of The Grenoble University Hospital — Grenoble
- Epileptology Department of the Lyon University Hospital — Lyon
- La Teppe medical centre — Tain-l'Hermitage
Идентификаторы
NCT: NCT04126369 · 38RC18.209