Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
- Conditions
- Lifestyle
- Interventions
- Behavioral: Cognitive Behavioral TherapyBehavioral: YogaBehavioral: Music
- Registration Number
- NCT05283200
- Lead Sponsor
- Imad Najm MD
- Brief Summary
A prospective controlled, randomized study to examine the effects of behavioral and wellness-based interventions on seizure frequency for adult patients with medication resistant epilepsy who are still experiencing 1 or more seizures per month.
- Detailed Description
In this prospective controlled, randomized study, investigators aim to assess the impact of integrative behavioral and wellness-based interventions on seizure frequency (primary outcome measure), stress, cognitive function, and quality of life (secondary outcome measures) in patients with difficult to treat epilepsy. The study team will accomplish these objectives through three active interventions that include: cognitive behavioral therapy (CBT), yoga therapy, and music therapy. This study will have two control groups who will continue with their standard of care as guided by their epilepsy provider. Investigators will measure the effects of our interventions using seizure diaries, cognitive assessments, and health and quality of life questionnaires. In this study, the study team will collect, process, store, and analyze human biospecimens of enrolled participants for research purposes to assess the potential biologic impact of our interventions. Collection, processing, storage, and data management of the biospecimens to be used for this study, and future studies, will be completed through Lerner Research Institute.
The CBT arm is currently closed to enrollment as of 8/14/2023.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Adult (ages 18-75) patients of the Cleveland Clinic Epilepsy Center with a confirmed diagnosis of epilepsy
- 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
- Patients with a history of non-epileptic or psychogenic seizures
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy 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. Yoga 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. Music 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.
- Primary Outcome Measures
Name Time Method Seizure Frequency 3-12 months from beginning of intervention Reduction in seizure frequency
- Secondary Outcome Measures
Name Time Method Change in Stress 3-12 months from beginning of intervention Change in stress as measured by improvement on the Generalized Anxiety Disorder 7 scales.
Quality of Life with Epilepsy 3-12 months from beginning of intervention Change in reported Quality of Life as measured by improvement in the Quality of Life in Epilepsy assessment.
Trial Locations
- Locations (1)
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States