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Trial record 21 of 1824 for:    epilepsy

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

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ClinicalTrials.gov Identifier: NCT04126369
Recruitment Status : Not yet recruiting
First Posted : October 15, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Other: mindfulness intervention Other: psycho educative programme Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Evolution of seizures frequency [ Time Frame: 9 months ]
    The number of seizures will be plot by the patient on a daily notebook throughout the study period.

  2. Evolution of psychiatric morbidity [ Time Frame: 9 months ]

    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


  3. Evolution of anxiety level [ Time Frame: 9 months ]

    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).


  4. Evolution of stress management [ Time Frame: 9 months ]

    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.


  5. Evolution of stress level [ Time Frame: 9 months ]
    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.

  6. Evolution of self acceptance and interoception [ Time Frame: 9 months ]

    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.


  7. Evolution of self acceptance and interoception [ Time Frame: 9 months ]

    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)


  8. Evolution of self acceptance and interoception [ Time Frame: 9 months ]

    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. Evolution of cognitive functions [ Time Frame: 9 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126369


Contacts
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Contact: Cécile SABOURDY, MD 04767656.9 ext +33 CSabourdy@chu-grenoble.fr

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

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04126369     History of Changes
Other Study ID Numbers: 38RC18.209
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Drug Resistant Epilepsy
mindfulness
self management
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases