Stress Management Intervention for Living With Epilepsy (SMILE) (SMILE)

April 17, 2018 updated by: Sheryl Haut, Montefiore Medical Center

Pre-emptive Treatment in Epilepsy Using Electronic Diaries: Towards a New Frontier in Epilepsy Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Progressive muscle relaxation
Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM
Behavioral: Progressive muscle relaxation

Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM

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: Sham exercise
Subjects practice a sham exercise consisting of focused attention activities
Behavioral: Sham exercise

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in seizure frequency
Time Frame: End of baseline and end of 12 week clinical trial
End of baseline and end of 12 week clinical trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

University of Cincinnati
Charles L Shor Foundation for Epilepsy Research

Investigators

  • Principal Investigator: Sheryl Haut, MD, Montefiore Medical Center
  • Principal Investigator: Michael Privitera, MD, University of Cincinnati
  • Principal Investigator: Susannah Cornes, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (ESTIMATE)

September 30, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-07-296E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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