Stress Management Intervention for Living With Epilepsy (SMILE)

Completed · Not applicable · Has a placebo group

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT01444183

Run by

Montefiore Medical Center

People needed

95

Starts

2012-01-01

Expected to finish

2015-01-01

Last updated by the study team

2018-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Patient-reported ability to self-predict seizures
• Patient-reported awareness of trigger factors, including stress
• 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

You may not qualify if…

• 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)

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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