Back to resultsMindfulness Meditation for Epilepsy (MIME)
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness meditation training
Therapeutic education
Sponsored by
About this trial
This is an interventional prevention trial for Epilepsy focused on measuring Mindfulness meditation
Eligibility Criteria
Inclusion Criteria:
For patients :
- Patients over 16 years of age;
- Epilepsy refractory to drug treatment according to the consensus criteria of the International League Against Epilepsy ;
- Affiliated with a health insurance plan;
- Free, informed and written consent signed by the patient, and parents for patients under the age of 18.
For healthy subjects :
- Healthy subjects 16 years of age and older;
- Affiliated with a health insurance plan;
- Free, informed and written consent signed by the volunteer, or parents, for volunteers under the age of 18.
Exclusion Criteria:
For patients :
- Alcohol Addiction Disorders (assessed by the Mini-International Neuropsychiatric Interview (MINI) scale) ;
- Patients with psychogenic crises;
- Treatment with antidepressants;
- Simultaneous participation in other research that may interfere with the protocol;
- Persons of legal age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
For healthy subjects :
- Psychiatric pathology and/or alcohol addiction disorders (evaluated by the MINI scale) ;
- Simultaneous participation in other research that may interfere with the protocol;
- Persons of legal age subject to legal protection (protection of justice, guardianship, trusteeship), persons deprived of liberty.
Sites / Locations
- Centre Hospitalier UniversitaireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Therapeutic education group
Mindfulness meditation group
Arm Description
The psychologist associated with the project takes care of the patient to receive a 1.5 hour therapeutic education interview ("control" group).
The psychologist associated with the project takes care of the patient to receive training in mindfulness meditation twice (1.5 hours) ("active" group)
Outcomes
Primary Outcome Measures
Short Form Quality of Life Questionnaire (SF36) score at 3 months
Change in the score on the Short Form Quality of Life Questionnaire (SF36) assessed before the intervention and at 3 months.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Secondary Outcome Measures
Short Form Quality of Life Questionnaire (SF36) score at 1 months
Change in the score on the Short Form Quality of Life Questionnaire (SF36) assessed before the intervention and at 1 month.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Depressive symptoms assessed on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month
MADRS score is evaluated before the intervention and at 1 month. Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
Depressive symptoms assessed on the Evolution of MADRS score at 3 months
MADRS score is evaluated before the intervention and at 3 months. Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 1 month
NDDI-E score is evaluated before the intervention and at 1 month. Depression scale score 0 to 24
Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 3 months
NDDI-E score is evaluated before the intervention and at 3 months. Depression scale score 0 to 24
Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 1 month.
Scores on the State-Trait Anxiety Inventory scale (STAI A and B) evaluated before the intervention and at 1 month.
STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;
Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 3 months.
Scores on the State-Trait Anxiety Inventory scale (STAI-Y A and B) evaluated before the intervention and at 3 months.
STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;
Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.
Scores on GAD-7 scale evaluated before the intervention and at 1 month. Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.
Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.
Scores on GAD-7 scale evaluated before the intervention and at 3 months. Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.
Seizure frequency at 1 month
Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.
Seizure frequency at 3 month
Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.
Full Information
NCT ID
NCT04687904
First Posted
December 18, 2020
Last Updated
December 13, 2022
Sponsor
Rennes University Hospital
Collaborators
Laboratoire Traitement du Signal et de l'Image, INSERM UMR1099 Rennes, Centre Hospitalier Guillaume Régnier, RENNES
1. Study Identification
Unique Protocol Identification Number
NCT04687904
Brief Title
Mindfulness Meditation for Epilepsy
Acronym
MIME
Official Title
Mindfulness Meditation for Epilepsy: Effect of Mindfulness Meditation Practice on Quality of Life and EEG Activity in Refractory Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Laboratoire Traitement du Signal et de l'Image, INSERM UMR1099 Rennes, Centre Hospitalier Guillaume Régnier, RENNES
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
In one-third of epileptic patients treated in France, seizures persist despite drug treatment. These so-called "refractory" epilepsies are among the most severe. Only a minority of patients with refractory epilepsy can undergo surgery. The other options available are based on brain or vagus nerve stimulation interventions which clinical effectiveness is still being studied. Alternative therapies are needed both to decrease the frequency of patients' seizures and to improve their quality of life.
The practice of mindfulness meditation has recently been included in the recommendations of the International League Against Epilepsy in order to alleviate anxiety or depression comorbid symptoms.
This study falls within this framework by targeting two aspects of the pathology.
Detailed Description
Through the development of standardized protocols, mindfulness meditation has been introduced as a complementary treatment to prevent the relapse of depression, and to reduce stress and improve well-being in many chronic conditions.
Epilepsy, which results from the activity of hyperexcitable circuits, is also associated with a disorganization of the physiological brain networks. Studies in cognitive neuroscience in healthy subjects suggest that meditation induces lasting changes in the physiological networks of attention and default mode and could potentially compensate for dysfunctions of these networks in epileptic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Mindfulness meditation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic education group
Arm Type
Active Comparator
Arm Description
The psychologist associated with the project takes care of the patient to receive a 1.5 hour therapeutic education interview ("control" group).
Arm Title
Mindfulness meditation group
Arm Type
Experimental
Arm Description
The psychologist associated with the project takes care of the patient to receive training in mindfulness meditation twice (1.5 hours) ("active" group)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness meditation training
Intervention Description
Patients will be able to benefit from mindfulness meditation training at the rate of 1h30 in the morning and 1h30 in the afternoon. During this training, patients will be invited to share with the psychologist their vision of mindfulness meditation and their expectations of this practice. The psychologist will then introduce what mindfulness is and how the sessions will take place. Several sessions guided by the psychologist will then be offered to the patient (body scan, focused attention, mindfulness movements...).
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic education
Intervention Description
Patients will benefit from a 2-hour interview which will be conducted by the psychologist associated with the project.
The aim of this interview is to help patients better understand their disease in order to adopt the right behaviors on a daily basis. This session will inform patients about their disease, its origins, its treatment, the difficulties it causes and the means to remedy it. The objective of this session is to better understand and manage epilepsy and to enable patients to take an active part in the process of care and management of the disease.
No specific instructions will be given at the end of this interview.
Primary Outcome Measure Information:
Title
Short Form Quality of Life Questionnaire (SF36) score at 3 months
Description
Change in the score on the Short Form Quality of Life Questionnaire (SF36) assessed before the intervention and at 3 months.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
At inclusion and at 3 months
Secondary Outcome Measure Information:
Title
Short Form Quality of Life Questionnaire (SF36) score at 1 months
Description
Change in the score on the Short Form Quality of Life Questionnaire (SF36) assessed before the intervention and at 1 month.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
At inclusion and at 1 month
Title
Depressive symptoms assessed on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month
Description
MADRS score is evaluated before the intervention and at 1 month. Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
Time Frame
At inclusion and at 1 month
Title
Depressive symptoms assessed on the Evolution of MADRS score at 3 months
Description
MADRS score is evaluated before the intervention and at 3 months. Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
Time Frame
At inclusion and at 3 months
Title
Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 1 month
Description
NDDI-E score is evaluated before the intervention and at 1 month. Depression scale score 0 to 24
Time Frame
At inclusion and at 1 month
Title
Depressive symptoms assessed on the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) at 3 months
Description
NDDI-E score is evaluated before the intervention and at 3 months. Depression scale score 0 to 24
Time Frame
At inclusion and at 3 months
Title
Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 1 month.
Description
Scores on the State-Trait Anxiety Inventory scale (STAI A and B) evaluated before the intervention and at 1 month.
STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;
Time Frame
At admission and at 1 month
Title
Anxiety symptoms assessed on the State-Trait Anxiety Inventory scale (STAI) at 3 months.
Description
Scores on the State-Trait Anxiety Inventory scale (STAI-Y A and B) evaluated before the intervention and at 3 months.
STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;
Time Frame
At inclusion and at 3 months
Title
Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.
Description
Scores on GAD-7 scale evaluated before the intervention and at 1 month. Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.
Time Frame
At admission and at 1 month
Title
Anxiety symptoms assessed on the General Anxiety Disorder 7 scale (GAD-7) at 1 month.
Description
Scores on GAD-7 scale evaluated before the intervention and at 3 months. Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.
Time Frame
At admission and at 3 months
Title
Seizure frequency at 1 month
Description
Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.
Time Frame
At 1 month
Title
Seizure frequency at 3 month
Description
Seizure frequency: self-assessed by the patient and those around him/her using a seizure diary.
Time Frame
At 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For patients :
Patients over 16 years of age;
Epilepsy refractory to drug treatment according to the consensus criteria of the International League Against Epilepsy ;
Affiliated with a health insurance plan;
Free, informed and written consent signed by the patient, and parents for patients under the age of 18.
For healthy subjects :
Healthy subjects 16 years of age and older;
Affiliated with a health insurance plan;
Free, informed and written consent signed by the volunteer, or parents, for volunteers under the age of 18.
Exclusion Criteria:
For patients :
Alcohol Addiction Disorders (assessed by the Mini-International Neuropsychiatric Interview (MINI) scale) ;
Patients with psychogenic crises;
Treatment with antidepressants;
Simultaneous participation in other research that may interfere with the protocol;
Persons of legal age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
For healthy subjects :
Psychiatric pathology and/or alcohol addiction disorders (evaluated by the MINI scale) ;
Simultaneous participation in other research that may interfere with the protocol;
Persons of legal age subject to legal protection (protection of justice, guardianship, trusteeship), persons deprived of liberty.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anca NICA, MD
Phone
+332 99 28 41 62
Email
anca.nica@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle MERLET, PhD
Email
isabelle.merlet@univ-rennes1.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle MERLET, PhD
Organizational Affiliation
LTSI - INSERM UMR 1099
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anca NICA, MD
Phone
+332 99 28 41 62
Email
anca.nica@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Anca NICA, MD
First Name & Middle Initial & Last Name & Degree
Serge Belliard, MD
First Name & Middle Initial & Last Name & Degree
Dominique Drapier, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Mindfulness Meditation for Epilepsy
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