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

NCT ID: NCT04126369

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2027-09-20

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.

Conditions

Drug Resistant Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

mindfulness intervention

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

Group Type: EXPERIMENTAL

mindfulness intervention

Intervention Type: OTHER

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.

Psycho educative programme

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

Group Type: ACTIVE_COMPARATOR

psycho educative programme

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Epileptology Department of The Grenoble University Hospital

Grenoble, , France

Site Status: RECRUITING

Epileptology Department of the Lyon University Hospital

Lyon, , France

Site Status: NOT_YET_RECRUITING

La Teppe medical centre

Tain-l'Hermitage, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Cécile SABOURDY, MD

Role: CONTACT

CSabourdy@chu-grenoble.fr

04767656.9 ext. +33

Facility Contacts

Cécile SABOURDY, MD

Role: primary

CSabourdy@chu-grenoble.fr

04 76 76 54 88 ext. +33

Julien JUNG, MD

Role: primary

Patrick PETIT, MD

Role: primary

Other Identifiers

38RC18.209

Identifier Type: -

Identifier Source: org_study_id