Clinical trial NCT04126369: Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
Official title: Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Resistant Epilepsy
Keywords: Drug Resistant Epilepsy
mindfulness
self management
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score.
timeFrame: 9 months
Secondary outcomes:
measure: Evolution of seizures frequency
timeFrame: 9 months
measure: Evolution of psychiatric morbidity
timeFrame: 9 months
measure: Evolution of anxiety level
timeFrame: 9 months
measure: Evolution of stress management
timeFrame: 9 months
measure: Evolution of stress level
timeFrame: 9 months
measure: Evolution of self acceptance and interoception
timeFrame: 9 months
measure: Evolution of self acceptance and interoception
timeFrame: 9 months
measure: Evolution of self acceptance and interoception
timeFrame: 9 months
measure: Evolution of cognitive functions
timeFrame: 9 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Epileptology Department of The Grenoble University Hospital
city: Lyon
country: France
facility: Epileptology Department of the Lyon University Hospital
city: Tain-l'Hermitage
country: France
facility: La Teppe medical centre
Study officials:
References: