Stress Management Intervention for Living With Epilepsy (SMILE)

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.

Inclusion Criteria:

- Age 18 years and above

- English speaking

- Partial epilepsy consistent with ILAE criteria supported by either EEG or MRI data

- Experiencing at least 2 seizures/month

- Reported awareness of all seizures, including seizures in a cluster

- One of the following:

1. Patient-reported ability to self-predict seizures

2. Patient-reported awareness of trigger factors, including stress

3. Patient-reported awareness of premonitory features

- Able to maintain accurate e-diary independently

- Minimum 6th grade reading level as screened by WRAT administration

- Must be on a stable dose of anti-epileptic drugs for at least 30 days prior to study
entry

- May be on stable dose of SSRI, SNRI, or atypical antipsychotic for at least 6 months

- May be on a stable dose of benzodiazepines (if so, dose stable for at least 30 days
prior to study entry)

For inclusion in clinical trial phase, patient must be/have:

- A minimum of 4 seizures documented in the 8-week baseline phase (or 6 seizures in the
12-week extended baseline phase)

- At least 1 seizure per 4-week period in two of the three 4-week periods in the
extended baseline phase

- Diaries satisfactorily completed during baseline phase

- Complied with study requirements during the baseline phase

Exclusion Criteria:

- Non-motor simple partial seizures only

- Concurrent VNS use

- History of suicide attempt within the past 2 years

- Current suicidality

- Not competent to sign consent

- Status epilepticus within the previous 6 months

- Began regularly using behavioral techniques for stress reduction within past 3 months

- Did not benefit from an adequate trial of a valid stress reduction technique

- Progressive neurologic condition that the investigator believes would affect seizure
frequency

- Any history of substance abuse within the previous 2 years

- History of poor medication compliance as judged by the investigator

- Psychiatric illness that requires change in medication dose

- Any medical or psychiatric condition that would impair reliable participation in the
trial

- Intermittent use of benzodiazepines (if used for sleep, will be determined case by
case)