Status:
COMPLETED
Stress Management Intervention for Living With Epilepsy (SMILE)
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Charles L Shor Foundation for Epilepsy Research
University of Cincinnati
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 inv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01444183
Start Date
January 1 2012
End Date
January 1 2015
Last Update
April 19 2018
Active Locations (3)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
3
University of Cincinnati
Cincinnati, Ohio, United States, 45267