Stress Management Intervention for Living With Epilepsy (SMILE)

Montefiore Medicine Academic Health System

Status

Completed

Conditions

Epilepsy

Treatments

Behavioral: Progressive muscle relaxation

Behavioral: Sham exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01444183

11-07-296E

Details and patient eligibility

About

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

Full 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.

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)