The Impact of Mindfulness Meditation in Veterans With Epilepsy: Can Seizures and Psychiatric Comorbidities Improve
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in number of seizures over time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Clinical providers in the epilepsy clinic are blinded
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in number of seizures over time
时间窗: 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.
Total number of seizures per 4 week periods will be compared over time.
次要结局
- Change in quality of life in epilepsy questionnaire (QOLIE-31) scores over time(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))
- Change in number of Emergency room (ER) visits(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.)
研究者
Maria Raquel Lopez
Primary Investigator
Miami VA Healthcare System