Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of Mindfulness Meditation in Veterans With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589755
Recruitment Status : Withdrawn (unable to recruit enough candidates)
First Posted : July 18, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Raquel Lopez, Miami VA Healthcare System

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Mindfulness meditation Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Clinical providers in the epilepsy clinic are blinded
Primary Purpose: Treatment
Official Title: The Impact of Mindfulness Meditation in Veterans With Epilepsy: Can Seizures and Psychiatric Comorbidities Improve
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Active Comparator: mindful meditation
Behavioral intervention, providing meditation
Behavioral: Mindfulness meditation
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

No Intervention: Waiting list
Patient on a waiting list



Primary Outcome Measures :
  1. Change in number of seizures over time [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in number of Emergency room (ER) visits [ Time Frame: 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. ]
    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.

  2. Change in quality of life in epilepsy questionnaire (QOLIE-31) scores over time [ Time Frame: 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) ]
    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.


Other Outcome Measures:
  1. Change in beck depression inventory I and II (BDI-II) scores over time [ Time Frame: baseline scores at the beginning of study, at the end of week 4 and week 8 during mindfulness study and a month after completing the study (at the end of week 12) ]
    We will compare the scores of BDI-II at the baseline, and after week 4 and week 8 during meditation study and 4 weeks after the completion of study. The BDI-II score range is from 0 to 63 with a higher score indicating a worsening of depression.

  2. Change in the Beck anxiety inventory (BAI) scores over time [ Time Frame: 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) ]
    We will compare the scores of the DAI at the baseline, then at the end of week 4 and week 8 during meditation study and 4 weeks after the completion of study. The BAI score range is from 0 to 63 with a higher score indicating a worsening anxiety.

  3. Change in the drug abuse screening test (dast-10) scores over time [ Time Frame: 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) ]
    We will compare the scores of the dast-10 at the baseline, then at the end of week 4 and week 8 during the meditation study and a month after the completion of the study. The dast 10 score range from 0 to 10 with a higher number indicating a worse drug addiction.

  4. Change in the Epworth Sleepiness Scale (ESS) [ Time Frame: 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) ]
    We will compare the score of the ESS at the baseline, then 4, 8 and 12 week after the baseline testing. The ESS score range is from 0 to 24 with a higher score indicating higher chance of dozing

  5. Change in the Alcohol use disorder identification test (AUDIT) [ Time Frame: 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) ]
    Score of AUDIT at the baseline, then at week 4 and week 8 during meditation study and 4 weeks after the completion of study. The AUDIT score range from 0 to more than 20 with a higher score indicating a higher use of alcohol

  6. Change of the insomnia severity index score (ISIS) [ Time Frame: 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) ]
    We will compare the score of ISIS at baseline, then at week 4 and week 8 during meditation study and 4 weeks after the completion of the study. The ISIS score range is from 0 to 28 with a higher score indicating higher severity of insomnia

  7. Change of the patients health questionnaire (PHQ-9) score [ Time Frame: 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) ]
    Score of PHQ questionnaire at the baseline, then at week 4 and week 8 during meditation study and 4 weeks after the completion of study. The PHQ-9 score range is from 0 to 27 with a higher score indicating a more severe depression.

  8. Change of the PCL-5 scores [ Time Frame: 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) ]
    The PCL- 5 is a 20-item self report measure that assesses the 20 DSM-5 symptoms of the PTSD .We will compare the scores of the PCL-5 at the baseline, then at the end of week 4 and week 8 during the meditation study and 4 weeks after the completion of the study. PCL for DSM-IV suggests that a 5-10 point change represents reliable change (i.e., change not due to chance) and a 10-20 point change represents clinically significant change.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of epilepsy, according to the using the 2014 International League Against Epilepsy criteria
  2. Adults over the age of 18
  3. Willingness to participate in mindfulness meditation sessions weekly for 8 weeks
  4. Being able to read at a 6th grade level.
  5. Being able to understand the study, consent form, and guided instructions during mindfulness meditation.

Exclusion Criteria:

  1. Having an isolated diagnosis of psychogenic non-epileptic seizures.
  2. Having a diagnosis of major neurocognitive disorder previously known as dementia which would make the patient unable to follow guided instructions during mindfulness meditation.

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): NCT03589755


Locations
Layout table for location information
United States, Florida
miami VAMC
Miami, Florida, United States, 33125
Sponsors and Collaborators
Miami VA Healthcare System
Investigators
Layout table for investigator information
Principal Investigator: Maria R Lopez, M.D Miami Veteran Affairs hospital
Publications of Results:

Layout table for additonal information
Responsible Party: Maria Raquel Lopez, Primary Investigator, Miami VA Healthcare System
ClinicalTrials.gov Identifier: NCT03589755    
Other Study ID Numbers: 1158499-1
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access request will be reviewed by an external independent reviewer panel. Requests will be required to sign a data access agreement
URL: http://IRBNET.org

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Raquel Lopez, Miami VA Healthcare System:
mindfulness
meditation
anxiety
depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases