EpilepsyNCT03589755
The Impact of Mindfulness Meditation in Veterans With Epilepsy
A study testing Mindfulness meditation in people with Epilepsy, run by Miami VA Healthcare System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Mindfulness Meditation in Veterans With Epilepsy: Can Seizures and Psychiatric Comorbidities Improve
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Mindfulness meditation
- Keywords
- mindfulness, meditation, anxiety, depression
- Medical subject headings
- Epilepsy, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| mindful meditation | Active comparator | Behavioral intervention, providing meditation Receives: Behavioral: Mindfulness meditation |
| Waiting list | No intervention | Patient on a waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of seizures over time
Total number of seizures per 4 week periods will be compared over time.
Measured: 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 outcomes (2)
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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start8 Feb 2019
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: unable to recruit enough candidates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami VA Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Maria Raquel Lopez, Miami VA Healthcare System
- Investigators
- Maria R Lopez, M.D, Principal investigator, Miami Veteran Affairs hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589755
- Sponsor's protocol ID
- 1158499-1
- Status last verified
- Sep 2020
- First submitted
- 14 May 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
Hauser WA, Annegers JF, Rocca WA. Descriptive epidemiology of epilepsy: contributions of population-based studies from Rochester, Minnesota. Mayo Clin Proc. 1996 Jun;71(6):576-86. doi: 10.4065/71.6.576.
PubMed 8642887Arias AJ, Steinberg K, Banga A, Trestman RL. Systematic review of the efficacy of meditation techniques as treatments for medical illness. J Altern Complement Med. 2006 Oct;12(8):817-32. doi: 10.1089/acm.2006.12.817.
PubMed 17034289Vezzani A, Lang B, Aronica E. Immunity and Inflammation in Epilepsy. Cold Spring Harb Perspect Med. 2015 Dec 18;6(2):a022699. doi: 10.1101/cshperspect.a022699.
PubMed 26684336Pascoe MC, Thompson DR, Jenkins ZM, Ski CF. Mindfulness mediates the physiological markers of stress: Systematic review and meta-analysis. J Psychiatr Res. 2017 Dec;95:156-178. doi: 10.1016/j.jpsychires.2017.08.004. Epub 2017 Aug 23.
PubMed 28863392Walker ER, Obolensky N, Dini S, Thompson NJ. Formative and process evaluations of a cognitive-behavioral therapy and mindfulness intervention for people with epilepsy and depression. Epilepsy Behav. 2010 Nov;19(3):239-46. doi: 10.1016/j.yebeh.2010.07.032. Epub 2010 Sep 15.
PubMed 20833592Acevedo BP, Pospos S, Lavretsky H. The Neural Mechanisms of Meditative Practices: Novel Approaches for Healthy Aging. Curr Behav Neurosci Rep. 2016;3(4):328-339. doi: 10.1007/s40473-016-0098-x. Epub 2016 Oct 18.
PubMed 27909646Moyer CA, Donnelly MP, Anderson JC, Valek KC, Huckaby SJ, Wiederholt DA, Doty RL, Rehlinger AS, Rice BL. Frontal electroencephalographic asymmetry associated with positive emotion is produced by very brief meditation training. Psychol Sci. 2011 Oct;22(10):1277-9. doi: 10.1177/0956797611418985. Epub 2011 Sep 15. No abstract available.
PubMed 21921291Tang YY, Lu Q, Feng H, Tang R, Posner MI. Short-term meditation increases blood flow in anterior cingulate cortex and insula. Front Psychol. 2015 Feb 26;6:212. doi: 10.3389/fpsyg.2015.00212. eCollection 2015.
PubMed 25767459Guidelines for epidemiologic studies on epilepsy. Commission on Epidemiology and Prognosis, International League Against Epilepsy. Epilepsia. 1993 Jul-Aug;34(4):592-6. doi: 10.1111/j.1528-1157.1993.tb00433.x. No abstract available.
PubMed 8330566
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mindfulness Meditation in Veterans With Epilepsy: Can Seizures and Psychiatric Comorbidities Improve
- ClinicalTrials.gov ID
- NCT03589755
- Acronym / sponsor ID
- 1158499-1
- Conditions
- Epilepsy
- Keywords
- mindfulness, meditation, anxiety, depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit enough candidates
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Miami VA Healthcare SystemUS federal agency
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 18 Jul 2018 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindful meditation | Active comparator | Behavioral: Mindfulness meditationBehavioral intervention, providing meditation |
| Waiting list | No intervention | –Patient on a waiting list |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 meditationThe 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 | Behavioural | mindful meditation |
Primary outcome
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.
2 secondary outcomes
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.
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Results publication: PubMed 8642887Hauser WA, Annegers JF, Rocca WA. Descriptive epidemiology of epilepsy: contributions of population-based studies from Rochester, Minnesota. Mayo Clin Proc. 1996 Jun;71(6):576-86. doi: 10.4065/71.6.576.
- Results publication: PubMed 17034289Arias AJ, Steinberg K, Banga A, Trestman RL. Systematic review of the efficacy of meditation techniques as treatments for medical illness. J Altern Complement Med. 2006 Oct;12(8):817-32. doi: 10.1089/acm.2006.12.817.
- Results publication: PubMed 26684336Vezzani A, Lang B, Aronica E. Immunity and Inflammation in Epilepsy. Cold Spring Harb Perspect Med. 2015 Dec 18;6(2):a022699. doi: 10.1101/cshperspect.a022699.
- Results publication: PubMed 28863392Pascoe MC, Thompson DR, Jenkins ZM, Ski CF. Mindfulness mediates the physiological markers of stress: Systematic review and meta-analysis. J Psychiatr Res. 2017 Dec;95:156-178. doi: 10.1016/j.jpsychires.2017.08.004. Epub 2017 Aug 23.
- Results publication: PubMed 20833592Walker ER, Obolensky N, Dini S, Thompson NJ. Formative and process evaluations of a cognitive-behavioral therapy and mindfulness intervention for people with epilepsy and depression. Epilepsy Behav. 2010 Nov;19(3):239-46. doi: 10.1016/j.yebeh.2010.07.032. Epub 2010 Sep 15.
- Results publication: PubMed 27909646Acevedo BP, Pospos S, Lavretsky H. The Neural Mechanisms of Meditative Practices: Novel Approaches for Healthy Aging. Curr Behav Neurosci Rep. 2016;3(4):328-339. doi: 10.1007/s40473-016-0098-x. Epub 2016 Oct 18.
- Results publication: PubMed 21921291Moyer CA, Donnelly MP, Anderson JC, Valek KC, Huckaby SJ, Wiederholt DA, Doty RL, Rehlinger AS, Rice BL. Frontal electroencephalographic asymmetry associated with positive emotion is produced by very brief meditation training. Psychol Sci. 2011 Oct;22(10):1277-9. doi: 10.1177/0956797611418985. Epub 2011 Sep 15. No abstract available.
- Results publication: PubMed 25767459Tang YY, Lu Q, Feng H, Tang R, Posner MI. Short-term meditation increases blood flow in anterior cingulate cortex and insula. Front Psychol. 2015 Feb 26;6:212. doi: 10.3389/fpsyg.2015.00212. eCollection 2015.
- Results publication: PubMed 8330566Guidelines for epidemiologic studies on epilepsy. Commission on Epidemiology and Prognosis, International League Against Epilepsy. Epilepsia. 1993 Jul-Aug;34(4):592-6. doi: 10.1111/j.1528-1157.1993.tb00433.x. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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. This study is not recruiting at the moment.
Maria R Lopez, M.D principal investigator
Miami Veteran Affairs hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation in people with Epilepsy, run by Miami VA Healthcare System at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589755, which also lists 9 linked publications.
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 3 Sep 2020.