Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
- Conditions
- Drug Resistant Epilepsy
- Interventions
- Other: mindfulness interventionOther: psycho educative programme
- Registration Number
- NCT04126369
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mindfulness intervention mindfulness intervention 12 mindfulness sessions for 3 months (1 session per week) Psycho educative programme psycho educative programme 12 psycho educative sessions for 3 months (1 session per week)
- Primary Outcome Measures
Name Time Method Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score. 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.
- Secondary Outcome Measures
Name Time Method Evolution of self acceptance and interoception 9 months The evolution of self acceptance and interoception will be assess with the Five Facet Mindfulness Questionnaire (FFMQ) The FFMQ questionnaires will be assess prior to intervention month 0 and then at month 3, month 6 and month 9 after the beginning of the intervention.
Ref: Baer, R.A., Carmody, J., \& Hunsinger, M (2012) FFMQ-SF. Journal of Clinical Psychology 7: 755-765 (2012)Evolution of anxiety level 9 months The evolution of anxiety level will be assess with the State Trait Anxiety Inventory (STAI) questionnaire.
The STAI questionnaire will be assess prior to intervention month 0 and then at month 3, month 6 and month 9 after the beginning of the intervention.
Ref : Spielberger CD, 1983. Traduction française Schweitzer MB et Paulhan I, 1990. D'après Guelfi JD (58).Evolution of stress management 9 months The evolution of stress management will be assess with the Emotion Regulation abilities Questionnaire (ERQ).
The ERQ questionnaire will be assess prior to intervention month 0 and then at month 3, month 6 and month 9 after the beginning of the intervention.Evolution of seizures frequency 9 months The number of seizures will be plot by the patient on a daily notebook throughout the study period.
Evolution of psychiatric morbidity 9 months The evolution of psychiatric morbidity will be assess with the Neurological Disorders Depression Inventory for Epilepsy (NNDI-E) questionnaire The NNDIE questionnaires will be assess prior to intervention month 0 and then at month 3, month 6 and month 9 after the beginning of the intervention.
Ref: Gilliam et al., The Lancet Neurology, 2006 Micoulaud-Franchi et al., Epilepsy and Behavior, 2015Evolution of stress level 9 months The evolution of stress will be assess with the level of cortisol salivary. The salivary cortisol level will be assess prior to intervention month 0 and then at month 3, month 6 and month 9 after the beginning of the intervention.
Evolution of cognitive functions 9 months The evolution of cognitive functions will be assess with the Cambridge Neuropsychological Test Automated Battery (CANTAB).
The CANTAB cognitive tests will be assess prior to intervention and then at month 3 and month 9 after the beginning of the intervention.
Trial Locations
- Locations (3)
Epileptology Department of The Grenoble University Hospital
🇫🇷Grenoble, France
Epileptology Department of the Lyon University Hospital
🇫🇷Lyon, France
La Teppe medical centre
🇫🇷Tain-l'Hermitage, France