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

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.

Study Overview

• Status: Recruiting
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Other: mindfulness intervention; Other: psycho educative 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cécile SABOURDY, MD; Phone Number: +33 04767656.9; Email: CSabourdy@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • Epileptology Department of The Grenoble University Hospital
    • Contact: Cécile SABOURDY, MD; Phone Number: +33 04 76 76 54 88; Email: CSabourdy@chu-grenoble.fr
  • Lyon, France
    • Not yet recruiting
    • Epileptology Department of the Lyon University Hospital
    • Contact: Julien JUNG, MD
  • Tain-l'Hermitage, France
    • Not yet recruiting
    • La Teppe medical centre
    • Contact: Patrick PETIT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mindfulness intervention; 12 mindfulness sessions for 3 months (1 session per week)	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.
Active Comparator: Psycho educative programme; 12 psycho educative sessions for 3 months (1 session per week)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score.	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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of seizures frequency	The number of seizures will be plot by the patient on a daily notebook throughout the study period.	9 months
Evolution of psychiatric morbidity	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, 2015	9 months
Evolution of anxiety level	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).	9 months
Evolution of stress management	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.	9 months
Evolution of stress level	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.	9 months
Evolution of self acceptance and interoception	The evolution of self acceptance and interoception will be assess with the Self-Compassion Scale - Short Form (SCS-SF) questionnaire. The SCS-SF 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: Raes, F., Pommier, E., Neff, K. D., & Van Gucht, D. (2011). Construction and factorial validation of a short form of the Self-Compassion Scale. Clinical Psychology & Psychotherapy. 18, 250-255.	9 months
Evolution of self acceptance and interoception	The evolution of self acceptance and interoception will be assess with the Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire. The MAIA 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: Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A (2012) The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS ONE 7(11)	9 months
Evolution of self acceptance and interoception	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)	9 months
Evolution of cognitive functions	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.	9 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Estimated): January 20, 2026
• Study Completion (Estimated): September 20, 2027

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: self management; mindfulness; Drug Resistant Epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 38RC18.209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No