Drug Resistant EpilepsyEPIMEDITNCT04126369
Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
A study testing mindfulness intervention and psycho educative programme in people with Drug Resistant Epilepsy, run by University Hospital, Grenoble at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- mindfulness intervention and psycho educative programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Jan 2020to 20 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Epileptology Department of The Grenoble University Hospital
Grenoble
Cécile SABOURDY, MD, 04 76 76 54 88 ext. +33, CSabourdy@chu-grenoble.fr
- Not yet recruiting
Epileptology Department of the Lyon University Hospital
Lyon
Julien JUNG, MD
- Not yet recruiting
La Teppe medical centre
Tain-l'Hermitage
Patrick PETIT, MD
About this study
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.
Read the 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.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- mindfulness intervention, psycho educative programme
- Keywords
- Drug Resistant Epilepsy, mindfulness, self management
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness interventionOther
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 programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness intervention | Experimental | 12 mindfulness sessions for 3 months (1 session per week) Receives: Other: mindfulness intervention |
| Psycho educative programme | Active comparator | 12 psycho educative sessions for 3 months (1 session per week) Receives: Other: psycho educative programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (9)
Evolution of seizures frequency
The number of seizures will be plot by the patient on a daily notebook throughout the study period.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start20 Jan 2020
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126369
- Sponsor's protocol ID
- 38RC18.209
- Acronym
- EPIMEDIT
- Status last verified
- May 2024
- First submitted
- 2 Aug 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
- ClinicalTrials.gov ID
- NCT04126369
- Acronym / sponsor ID
- EPIMEDIT / 38RC18.209
- Conditions
- Drug Resistant Epilepsy
- Keywords
- Drug Resistant Epilepsy, mindfulness, self management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness intervention | Experimental | Other: mindfulness intervention12 mindfulness sessions for 3 months (1 session per week) |
| Psycho educative programme | Active comparator | Other: psycho educative programme12 psycho educative sessions for 3 months (1 session per week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness interventionThe 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. | Other | mindfulness intervention |
| psycho educative programmeThe 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. | Other | Psycho educative programme |
Primary outcome
Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score.
Time frame: 9 months
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 secondary outcomes
Evolution of seizures frequency
Time frame: 9 months
Evolution of psychiatric morbidity
Time frame: 9 months
Evolution of anxiety level
Time frame: 9 months
Evolution of stress management
Time frame: 9 months
Evolution of stress level
Time frame: 9 months
Evolution of self acceptance and interoception
Time frame: 9 months
Evolution of self acceptance and interoception
Time frame: 9 months
Evolution of self acceptance and interoception
Time frame: 9 months
Evolution of cognitive functions
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness intervention and psycho educative programme in people with Drug Resistant Epilepsy, run by University Hospital, Grenoble at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cécile SABOURDY, MD (04767656.9 ext. +33, CSabourdy@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.