NCT05283200

Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Imad Najm MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lifestyle

Interventions

Type	Name	Description
BEHAVIORAL	Yoga	Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction
BEHAVIORAL	Cognitive Behavioral Therapy	Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills
BEHAVIORAL	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.

Timeline

• Start date: 2022-02-11
• Primary completion: 2026-02-28
• Completion: 2026-06-01
• First posted: 2022-03-16
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States