The Impact of Mindfulness Meditation in Veterans With Epilepsy

Study Overview
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Brief Summary
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Epilepsy is one of the fourth most common neurological disorder and affects people of all ages and about 25 % of those patients have medically intractable epilepsy. Since the traditional pharmaceutical and surgical approach is not always effective, this study intends to investigate a novel approach using mindfulness as adjunctive tool of treatment for veterans with epilepsy. This study proposes a randomized, single-blinded pilot investigative trial to assess the effectiveness of mindfulness meditation. The measures outcomes include seizure frequency, number of ER visits, quality of life, depression, anxiety, post traumatic stress disorder (PTSD), sleep quality and alcohol use in patients with Epilepsy. The cohort group will be randomized in two groups, one is the group of patients getting mindful meditation weekly during 8 weeks compared to patients in the waiting list who have the desire to participate.

Detailed Description
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This is a randomized control trial of the impact of mindfulness meditation in patients with known diagnosis of epilepsy over the course of 2 years. Participating physicians will recruit patients meeting the inclusion and exclusion criteria who have been diagnosed and treated in the epilepsy clinic at the Miami Veteran hospital. Upon completion of screening and enrolment procedures study participants will be randomly assigned to one of the two groups using a randomized call-in system: Treatment with weekly sessions of mindfulness meditation for 8 weeks or placement in the waiting list. Demographics will be obtained for both groups during the initial clinic visit. The epilepsy variable questionnaire will also be completed during the initial appointment in the epilepsy clinic (this will assess seizure frequency, number of ER visits 3 months prior, adherence to antiepileptic medications reviewing the electronic pharmacy log with dates of medication being dispensed at the Veteran Medical Center. All patients will be scheduled to have an initial appointment with the clinical psychologist to fill out the complete a battery of questionnaires including: Quality of life inventory in epilepsy (QOLIE-31), alcohol use disorder identification test (AUDIT), Beck depression inventory (BDI-II), Beck anxiety inventory (BAI), drug abuse screening test (dast-10), Epworth Sleepiness Scale, Insomnia severity, patient health questionnaires (PHQ), Post traumatic The patients who do not initially receive mindfulness meditation will continue to receive standard of care and will be placed in a second phase of randomization where they will have a chance to once again be randomized to one of the groups. This process will continue until a total of at least 40 patients has been recruited. After the recruitment has been completed, the remainder of the patients will be given the opportunity to participate in mindfulness medication if they so desire. The hypothesis is that mindfulness meditation group will have more favorable outcomes than patients in the waitlist group in terms of the primary outcome of reduction in seizure frequency and secondary outcomes including number of ER visits, improvement in quality of life, decreasing symptoms of depression, anxiety, and/or PTSD, improvement in sleep quality, and decreased alcohol use. Physicians will be blinded to which group patients are assigned during data collection. All of the participants will have a weekly clinic note titled Psychology Note in the clinic MIA MH PSYCHOL MINDFUL GRP. The notes will document the session if patient is in the mindfulness meditation group or will document that the patient remains on the waiting list. The physicians will not access these notes and will remain blinded to the patient assignment and upon completion of the study the data will be de-identified and analyzed by the statistician.

Official Title
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The Impact of Mindfulness Meditation in Veterans With Epilepsy: Can Seizures and Psychiatric Comorbidities Improve

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Mindfulness meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of epilepsy, according to the using the 2014 International League Against Epilepsy criteria Adults over the age of 18 Willingness to participate in mindfulness meditation sessions weekly for 8 weeks Being able to read at a 6th grade level. Being able to understand the study, consent form, and guided instructions during mindfulness meditation. Exclusion Criteria: Having an isolated diagnosis of psychogenic non-epileptic seizures. Having a diagnosis of major neurocognitive disorder previously known as dementia which would make the patient unable to follow guided instructions during mindfulness meditation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mindful meditation<br>Behavioral intervention, providing meditation | Behavioral: Mindfulness meditation<br>* The intervention consist of a weekly session of mindfulness meditation provided by a clinical psychologist trained in this area. She will provide weekly session to a group of 10 patients at a time for a total of 8 weeks. Upon completing the course, the other 10 people will start<br>|
| No Intervention: Waiting list<br>Patient on a waiting list | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of seizures over time | Total number of seizures per 4 week periods will be compared over time. | Number of seizures in 4 weeks (baseline) prior to beginning the mindfulness study and then week 4, 8 and 12 from the begining of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of Emergency room (ER) visits | Number of ER visits during 3 months (baseline) prior to meditation study compared with number of ER visits during three months after the completion of meditation. | At the beginning of study ( will iclude number of ER visit 3 month prior to enrollment in study. Then at week 12 and 3 months after completing the study. | 
| Change in quality of life in epilepsy questionnaire (QOLIE-31) scores over time | Score of QOLIE - 31 at the baseline, then at week 4 and week 8 during meditation study and 4 weeks after the completion of study. The QoLIE-31 score range is from 0 to 100 with a higher score indicating a better outcome for quality of life. | At the beginning of mindfulness study (baseline) and then at the end of weeks 4 and 8 during mindfulness study and one month after completion of meditation sessions (post study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, meditation, anxiety, depression