Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mindfulness intervention, psycho educative programme.
- Who it may be relevant to
- Registry conditions: Drug Resistant Epilepsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other 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. - Other 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.
Primary outcome measures
- Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score. [Time frame: 9 months]
Secondary outcome measures (9)
- Evolution of seizures frequency [Time frame: 9 months]
- Evolution of psychiatric morbidity [Time frame: 9 months]
- Evolution of anxiety level [Time frame: 9 months]
- Evolution of stress management [Time frame: 9 months]
- Evolution of stress level [Time frame: 9 months]
- Evolution of self acceptance and interoception [Time frame: 9 months]
- Evolution of self acceptance and interoception [Time frame: 9 months]
- Evolution of self acceptance and interoception [Time frame: 9 months]
- Evolution of cognitive functions [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 3 centers
- Epileptology Department of The Grenoble University Hospital — Grenoble
- Epileptology Department of the Lyon University Hospital — Lyon
- La Teppe medical centre — Tain-l'Hermitage
Identifiers
NCT: NCT04126369 · 38RC18.209