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Stress Management Intervention for Living With Epilepsy (SMILE)

NCT01444183 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2018-04-19

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Charles L Shor Foundation for Epilepsy Research

    collaborator UNKNOWN

  • University of Cincinnati

    collaborator OTHER

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Sheryl Haut, MD · Montefiore Medical Center

  • Michael Privitera, MD · University of Cincinnati

  • Susannah Cornes, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01444183 on ClinicalTrials.gov