The Impact of Mindfulness Meditation in Veterans With Epilepsy

NCT03589755 | Withdrawn DMC

• 1 other identifier: 1158499-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

mindfulness; meditation; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• 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)

Other Outcomes (8)

• Change in beck depression inventory I and II (BDI-II) scores over time

  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)

• Change in the Beck anxiety inventory (BAI) 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 the drug abuse screening test (dast-10) 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)

Study Arms (2)

mindful meditation

ACTIVE COMPARATOR

Behavioral intervention, providing meditation

Behavioral: Mindfulness meditation

Waiting list

NO INTERVENTION

Patient on a waiting list

Interventions

Mindfulness meditation BEHAVIORAL

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

mindful meditation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Miami VA Healthcare System: lead

Study Sites (1)

miami VAMC

Miami, Florida, 33125, United States

Location

Related Publications (9)

• 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.

  PMID: 8642887 RESULT

• Arias 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.

  PMID: 17034289 RESULT

• Vezzani 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.

  PMID: 26684336 RESULT

• Pascoe 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.

  PMID: 28863392 RESULT

• Walker 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.

  PMID: 20833592 RESULT

• Acevedo 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.

  PMID: 27909646 RESULT

• Moyer 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.

  PMID: 21921291 RESULT

• Tang 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.

  PMID: 25767459 RESULT

• Guidelines 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.

  PMID: 8330566 RESULT

MeSH Terms

Conditions

Epilepsy; Anxiety Disorders; Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria R Lopez, M.D

  Miami Veteran Affairs hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Clinical providers in the epilepsy clinic are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: July 18, 2018
• Study Start: February 8, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

US (1)