The SMILE Study

More than half of people with epilepsy say that stress can cause a seizure to happen or can make a seizure worse. But doctors don’t know for sure that this is true.

To find out whether stress can trigger seizures and whether reducing stress can reduce or eliminate them, researchers have been conducting a unique study at the UC Epilepsy Center, the Montefiore Medical Center of the Albert Einstein College of Medicine at Yeshiva University, and the University of California San Francisco. The study is called SMILE, for Stress Management Intervention for Living with Epilepsy.

The SMILE study is ongoing but closed to enrollment,
and data is currently being analyzed.

The study, a randomized, controlled double-blind trial, enrolled participants who have medication-resistant partial seizures.

The study was designed with two parts. During the first part, study participants kept a “phone diary” in order to provide information that helps researchers understand stress and seizures. Two times a day, study participants entered information into a specially programmed smartphone. They answered questions about how they felt: Do you feel stress? Do you feel nervous? Do you feel happy? Do you feel sad?

Study participants were asked a variety of questions about mood and tension, because stress can be interpreted differently by different people. Researchers hope the participants’ phone diaries will clarify what stress means and what type of stress, if any, can be linked to seizures.

Researchers report that compliance with the phone-based diaries during the study was extremely high (94%). Data collected on stress and mood variables, plus seizure prediction, is currently being analyzed.

In the second part of the SMILE study, researchers introduced study participants to a stress management exercise. The participants were divided into two groups, or study arms. Participants in the two groups were given different types of focused-attention and relaxation exercises to perform twice daily, with additional practices on days when they indicated with their smartphone that their stress level was high and they were at risk of having a seizure. Study participants received the intervention therapy through their smartphone.

At the end of the study, all participants had a chance to receive the focused-attention and relaxation treatments that worked best.

For more information about the SMILE study, contact Adrienne Fleck, RN, at (513) 558-3726 or fleckar@ucmail.uc.edu.