Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
NCT ID: NCT05283200
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1000 participants
INTERVENTIONAL
2022-02-11
2026-06-30
Brief Summary
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Detailed Description
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The CBT arm is currently closed to enrollment as of 8/14/2023.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Yoga
The goal for the yoga intervention is to provide participants with instructor-guided safe, gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, anxiety symptoms, disability, and improve quality of life.
Participants enrolled in the Yoga intervention group will receive one month of Instructor-Guided 70-minute virtual live yoga classes, twice per week, led by an experienced yoga therapist and co-instructor. During Months 2-3 participants in the Yoga Intervention will receive one 70-minute virtual live yoga class per week. Each session will have a set of specific poses, breathing exercises, meditation, and yoga philosophies developed by our yoga experts.
Yoga
Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction
Cognitive Behavioral Therapy
The goal of the Cognitive Behavioral Therapy (CBT) intervention is to provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, depression and anxiety symptoms, disability and improve quality of life.
Participants enrolled in the CBT intervention group will receive 3 months of Instructor-Guided 90-minute, virtual group counseling session, once per week, led by a psychologist and a co-therapist.
Cognitive Behavioral Therapy
Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills
Music
The aim of this intervention is for participants to learn and develop skills to reduce stress which may, in turn, decrease seizure frequency and improve quality of life. Participants will be exposed to a variety of ways that they might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction.
Participants enrolled in the Music Intervention group will receive one month of Instructor-Guided Intervention 70-minute virtual live music therapy sessions, twice per week, led by an experienced music therapist and co-instructor. An two months of a 70-minute virtual live music therapy session once per week.
Music
Music therapist will teach a variety of ways that participants might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction.
Standard of Care
Participants randomized to the Standard of Care Control Group will receive their usual standard epilepsy care. For Months 1-3 participants will receive weekly online surveys as well as brief monthly calls checking-in and collecting their seizure frequency. Participants will continue to receive brief monthly calls for checking-in and collection of seizure frequency Months 4-12. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.
No interventions assigned to this group
Enhanced Standard of Care
Participants randomized to the Enhanced Standard of Care Control Group will receive their usual standard epilepsy care and weekly scheduled, scripted, follow-up phone calls from a study team member to check-in on their health, epilepsy management, and seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish.
No interventions assigned to this group
Interventions
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Yoga
Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction
Cognitive Behavioral Therapy
Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills
Music
Music therapist will teach a variety of ways that participants might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction.
Eligibility Criteria
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Inclusion Criteria
* Ability to independently provide informed consent
* At the time of enrollment, patients must have had at least 1 seizure within the past 30 days
* No anticipated anti-seizure medication adjustments
* Internet access and the ability to participate in online video streaming
* Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4) Reading subtest
* Willing and able to participate in any of the assigned interventions which may include yoga or music therapy
Exclusion Criteria
* Any patient that has engaged in yoga or music therapy within the last 6 months
* Currently enrolled in another interventional study for epilepsy at the time of enrollment.
* Anticipated or scheduled epilepsy surgery within 6 months
* Pending litigation related to the cause of epilepsy or current application for long term disability
* Participants with a diagnosed, symptomatic, chronic illness (i.e., significant psychiatric concerns, liver, gastrointestinal, respiratory, renal, cardiac, etc.) who, based on primary investigator review, will not be able to participate in the study safely or effectively.
* Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that would impact study participation.
* Currently pregnant or less than 6 weeks postpartum
* Significant hearing loss
* Blindness
* Musicogenic epilepsy or seizures
18 Years
75 Years
ALL
No
Sponsors
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Imad Najm MD
OTHER
Responsible Party
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Imad Najm MD
Principal Investigator
Principal Investigators
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Imad Najm, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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IRB 21-975
Identifier Type: -
Identifier Source: org_study_id
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