Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy. (EPIMEDIT)

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: Drug Resistant Epilepsy

Treatments: Other: psycho educative programme; Other: mindfulness intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04126369

38RC18.209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

mindfulness intervention

Experimental group

Description:

12 mindfulness sessions for 3 months (1 session per week)

Treatment:

Other: mindfulness intervention

Psycho educative programme

Active Comparator group

Description:

12 psycho educative sessions for 3 months (1 session per week)

Treatment:

Other: psycho educative programme