Stress Management Intervention for Living With Epilepsy (SMILE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Behavioral: Focused Attention A Behavioral: Focused Attention B |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Pre-emptive Treatment in Epilepsy Using Electronic Diaries: Towards a New Frontier in Epilepsy Therapy |
- Change in seizure frequency [ Time Frame: End of baseline and end of 12 week clinical trial ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Focused Attention A |
Behavioral: Focused Attention A
The focused attention practices will consist of one or more of the following components: movement of body parts, breathing exercises, and writing exercises. Both groups will practice twice daily, one 15 minute practice in the AM and a 5 minute practice in the PM. An additional 5 minute mid-day practice will occur only when e-diary entries from experience sampling meet specific predetermined criteria. |
| Sham Comparator: Focused Attention B |
Behavioral: Focused Attention B
The focused attention practices will consist of one or more of the following components: movement of body parts, breathing exercises, and writing exercises. Both groups will practice twice daily, one 15 minute practice in the AM and a 5 minute practice in the PM. An additional 5 minute mid-day practice will occur only when e-diary entries from experience sampling meet specific predetermined criteria. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- 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 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)
Contacts and Locations| Contact: Emily Polak, PhD | 718-920-6033 | epolak@montefiore.org |
| Contact: Adrienne Fleck, RN | 513-558-3726 | fleckar@UCMAIL.UC.EDU |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Emily Polak, PhD 718-920-6033 epolak@montefiore.org | |
| Principal Investigator: Sheryl Haut, MD | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Adrienne Fleck, RN 513-558-3726 fleckar@ucmail.uc.edu | |
| Principal Investigator: Mike Privitera, MD | |
| Principal Investigator: | Sheryl Haut, MD | Montefiore Medical Center |
| Principal Investigator: | Michael Privitera, MD | University of Cincinnati |
More Information
Publications:
| Responsible Party: | Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT01444183 History of Changes |
| Other Study ID Numbers: | 11-07-296E |
| Study First Received: | September 15, 2011 |
| Last Updated: | August 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Montefiore Medical Center:
|
Epilepsy seizures stress reduction |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013