Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy. (EPIMEDIT)
Primary Purpose
Drug Resistant Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mindfulness intervention
psycho educative programme
Sponsored by
About this trial
This is an interventional other trial for Drug Resistant Epilepsy focused on measuring Drug Resistant Epilepsy, mindfulness, self management
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.
Sites / Locations
- Epileptology Department of The Grenoble University HospitalRecruiting
- Epileptology Department of the Lyon University Hospital
- La Teppe medical centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mindfulness intervention
Psycho educative programme
Arm Description
12 mindfulness sessions for 3 months (1 session per week)
12 psycho educative sessions for 3 months (1 session per week)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evolution of seizures frequency
The number of seizures will be plot by the patient on a daily notebook throughout the study period.
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
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).
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.
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.
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.
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)
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)
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.
Full Information
NCT ID
NCT04126369
First Posted
August 2, 2019
Last Updated
May 15, 2023
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04126369
Brief Title
Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
Acronym
EPIMEDIT
Official Title
Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
September 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
First phase: comparative randomized study (primary endpoint):
After inclusion, a 2 months baseline follow-up is carry to collect the judgement criteria without intervention.
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.
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".
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy
Keywords
Drug Resistant Epilepsy, mindfulness, self management
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mindfulness intervention
Arm Type
Experimental
Arm Description
12 mindfulness sessions for 3 months (1 session per week)
Arm Title
Psycho educative programme
Arm Type
Active Comparator
Arm Description
12 psycho educative sessions for 3 months (1 session per week)
Intervention Type
Other
Intervention Name(s)
mindfulness intervention
Intervention Description
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
Intervention Name(s)
psycho educative programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score.
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Evolution of seizures frequency
Description
The number of seizures will be plot by the patient on a daily notebook throughout the study period.
Time Frame
9 months
Title
Evolution of psychiatric morbidity
Description
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
Time Frame
9 months
Title
Evolution of anxiety level
Description
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).
Time Frame
9 months
Title
Evolution of stress management
Description
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.
Time Frame
9 months
Title
Evolution of stress level
Description
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.
Time Frame
9 months
Title
Evolution of self acceptance and interoception
Description
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.
Time Frame
9 months
Title
Evolution of self acceptance and interoception
Description
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)
Time Frame
9 months
Title
Evolution of self acceptance and interoception
Description
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)
Time Frame
9 months
Title
Evolution of cognitive functions
Description
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.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile SABOURDY, MD
Phone
04767656.9
Ext
+33
Email
CSabourdy@chu-grenoble.fr
Facility Information:
Facility Name
Epileptology Department of The Grenoble University Hospital
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile SABOURDY, MD
Phone
04 76 76 54 88
Ext
+33
Email
CSabourdy@chu-grenoble.fr
Facility Name
Epileptology Department of the Lyon University Hospital
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien JUNG, MD
Facility Name
La Teppe medical centre
City
Tain-l'Hermitage
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick PETIT, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
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