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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction
Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills
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.
Cleveland Clinic
Cleveland, Ohio, United States
Seizure Frequency
Reduction in seizure frequency
Time frame: 3-12 months from beginning of intervention
Change in Stress
Change in stress as measured by improvement on the Patient Health Questionnaire-8.
Time frame: 3-12 months from beginning of intervention
Change in Stress
Change in stress as measured by improvement on the Generalized Anxiety Disorder 7 scales.
Time frame: 3-12 months from beginning of intervention
Quality of Life with Epilepsy
Change in reported Quality of Life as measured by improvement in the Quality of Life in Epilepsy assessment.
Time frame: 3-12 months from beginning of intervention
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