Stress Management Intervention for Living With Epilepsy (SMILE)

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Behavioral: Progressive muscle relaxation; Behavioral: Sham exercise

• Registration Number: NCT01444183
• Lead Sponsor: Montefiore Medical Center

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 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.

Study Timeline

• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-30
• Study Start: 2012-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progressive muscle relaxation	Progressive muscle relaxation	Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM
Sham exercise	Sham exercise	Subjects practice a sham exercise consisting of focused attention activities

Primary Outcome Measures

Name	Time	Method
Change in seizure frequency	End of baseline and end of 12 week clinical trial

Trial Locations

Locations (3)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States