NCT01444183

Stress Management Intervention for Living With Epilepsy (SMILE)

Pre-emptive Treatment in Epilepsy Using Electronic Diaries: Towards a New Frontier in Epilepsy Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy.

Detailed description

The study will examine whether a stress reduction intervention reduces the number of seizures in people with drug resistant epilepsy. In the proposed randomized controlled, double blind trial, the investigators will enroll subjects with frequent seizures, especially those who identify stress as a seizure precipitant. There is an observational phase (8-12 weeks) and a treatment phase (12 weeks). During the observational phase, subjects will be monitored multiple times daily via smart phone devices, in order to identify high risk days for seizures. In the treatment phase, subjects will be randomly assigned to one of two groups receiving different focused attention practices. These behavioral interventions will be administered daily with extra interventions applied on days of higher risk.

Conditions

• Epilepsy

Interventions

Type	Name	Description
BEHAVIORAL	Progressive muscle relaxation	Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM Both groups will practice twice daily, one 15 minute practice in the AM and a 5 minute practice in the PM. An additional 5 minute mid-day practice will occur only when e-diary entries from experience sampling meet specific predetermined criteria.
BEHAVIORAL	Sham exercise	The focused attention practices will consist of one or more of the following components: movement of body parts, breathing exercises, and writing exercises. Both groups will practice twice daily, one 15 minute practice in the AM and a 5 minute practice in the PM. An additional 5 minute mid-day practice will occur only when e-diary entries from experience sampling meet specific predetermined criteria.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2011-09-30
• Last updated: 2018-04-19

Locations

3 sites across 1 country: United States