Stress Management Intervention for Living With Epilepsy (SMILE)

NCT01444183 | Completed DMC

• 1 other identifier: 11-07-296E
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Epilepsy

Keywords

Epilepsy; seizures; stress reduction

Outcome Measures

Primary Outcomes (1)

• Change in seizure frequency

  End of baseline and end of 12 week clinical trial

Study Arms (2)

Progressive muscle relaxation

ACTIVE COMPARATOR

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

Behavioral: Progressive muscle relaxation

Sham exercise

SHAM COMPARATOR

Subjects practice a sham exercise consisting of focused attention activities

Behavioral: Sham exercise

Interventions

Progressive muscle relaxation BEHAVIORAL

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.

Progressive muscle relaxation

Sham exercise BEHAVIORAL

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 exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• A minimum of 4 seizures documented in the 8-week baseline phase (or 6 seizures in the 12-week extended baseline phase)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Charles L Shor Foundation for Epilepsy Research: collaborator
• University of Cincinnati: collaborator

Study Sites (3)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (6)

• Hall CB, Lipton RB, Tennen H, Haut SR. Early follow-up data from seizure diaries can be used to predict subsequent seizures in same cohort by borrowing strength across participants. Epilepsy Behav. 2009 Mar;14(3):472-5. doi: 10.1016/j.yebeh.2008.12.011. Epub 2009 Jan 10.

  PMID: 19138755 BACKGROUND

• Haut SR, Hall CB, Masur J, Lipton RB. Seizure occurrence: precipitants and prediction. Neurology. 2007 Nov 13;69(20):1905-10. doi: 10.1212/01.wnl.0000278112.48285.84.

  PMID: 17998482 BACKGROUND

• Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.

  PMID: 19646331 BACKGROUND

• Nickel C, Kettler C, Muehlbacher M, Lahmann C, Tritt K, Fartacek R, Bachler E, Rother N, Egger C, Rother WK, Loew TH, Nickel MK. Effect of progressive muscle relaxation in adolescent female bronchial asthma patients: a randomized, double-blind, controlled study. J Psychosom Res. 2005 Dec;59(6):393-8. doi: 10.1016/j.jpsychores.2005.04.008.

  PMID: 16310021 BACKGROUND

• Privitera M, Haut SR, Lipton RB, McGinley JS, Cornes S. Seizure self-prediction in a randomized controlled trial of stress management. Neurology. 2019 Nov 26;93(22):e2021-e2031. doi: 10.1212/WNL.0000000000008539. Epub 2019 Oct 23.

  PMID: 31645468 DERIVED

• Haut SR, Lipton RB, Cornes S, Dwivedi AK, Wasson R, Cotton S, Strawn JR, Privitera M. Behavioral interventions as a treatment for epilepsy: A multicenter randomized controlled trial. Neurology. 2018 Mar 13;90(11):e963-e970. doi: 10.1212/WNL.0000000000005109. Epub 2018 Feb 14.

  PMID: 29444968 DERIVED

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sheryl Haut, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Michael Privitera, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Susannah Cornes, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dept of Medicine (Critical Care)

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 30, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 19, 2018

Record last verified: 2015-04

Locations

US (3)