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Efficacy of Behavioral Insomnia Treatment for Chronic Migraine

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ClinicalTrials.gov Identifier: NCT01314651
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : April 24, 2014
Information provided by (Responsible Party):

March 11, 2011
March 14, 2011
April 24, 2014
March 2011
December 2013   (Final data collection date for primary outcome measure)
Headache frequency [ Time Frame: 2 weeks post-treatment, 6 weeks post-treatment ]
Same as current
Complete list of historical versions of study NCT01314651 on ClinicalTrials.gov Archive Site
  • Headache severity [ Time Frame: 2 weeks post-treatment, 6 weeks post-treatment ]
  • Headache-related disability [ Time Frame: 2 weeks post-treatment; 6 weeks post-treatment ]
  • Total Sleep Time [ Time Frame: 2 weeks post-treatment; 6 weeks post-treatment ]
Same as current
Not Provided
Not Provided
Efficacy of Behavioral Insomnia Treatment for Chronic Migraine
Efficacy of Behavioral Insomnia Treatment for Chronic Migraine: A Randomized Controlled Pilot Study
The purpose of this study is to test the efficacy of a brief behavioral insomnia intervention in reducing headache frequency and severity among patients with chronic migraine and insomnia. It is hypothesized that this intervention will produce greater changes in headache frequency and severity than will a comparison treatment involving non-sleep-specific general lifestyle modifications.
Chronic migraine (occurring 15 or more days per month) is a disabling disorder that engenders significant personal suffering and healthcare costs. Frequently, individuals with chronic migraine also suffer from symptoms of insomnia, the regulation of which has been shown to improve migraine. A variety of effective and well-validated behavioral treatments exist to reduce symptoms of insomnia but have not been widely applied to migraine patients. The goal of this study is to pilot test and compare the efficacy of 2 different behavioral (non-medication) treatments for chronic migraine, one of which addresses insomnia symptoms and one of which addresses general lifestyle changes, on headache and sleep parameters. Patients will be adults (18-65) diagnosed with chronic migraine and insomnia at the Oxford Neurology Clinic when they present for routine medical appointments. They will be maintained on usual medical care and referred to the Psychological Services Center for collection of baseline data and administration of the behavioral interventions. At baseline participants will be administered a structured interview and questionnaires pertaining to headache symptoms, sleep problems, and depression/anxiety. They will keep a daily diary of headache variables for 2 weeks and wear an actigraph on their wrist during baseline. Patients will be randomly assigned to receive either the a treatment focused on modifying general lifestyle behaviors (Lifestyle Modification; a replication of the instructions from Calhoun and Ford, 2007) or making changes to their sleep behaviors (Sleep Management) for 3 brief (20-30 min) sessions, spaced 2 weeks apart. Treatments will entail education/rationale about the intervention and a review of a set of instructions unique to each condition. Subsequent sessions will ensure compliance with the respective instructions. Daily monitoring of headache symptoms will continue throughout the trial. Participants will complete the aforementioned questionnaires at 2 posttreatment follow-up visits and wear the actigraph again for 2 week periods surrounding the 2 follow-up visits.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Migraine
  • Insomnia
  • Behavioral: Stimulus Control and Sleep Restriction
    5 instructions in stimulus control and individually-tailored sleep restriction
  • Behavioral: Lifestyle Modification
    5 instructions in changing general lifestyle habits (maintaining consistent liquid intake, range of motion exercises, eating a serving of protein in the morning, etc.)
  • Experimental: Sleep Management
    Instructions in stimulus control and sleep restriction.
    Intervention: Behavioral: Stimulus Control and Sleep Restriction
  • Sham Comparator: Lifestyle Modification
    Instructions to change general lifestyle habits (maintain consistent liquid consumption, range of motion exercises, etc.)
    Intervention: Behavioral: Lifestyle Modification
Smitherman TA, Walters AB, Davis RE, Ambrose CE, Roland M, Houle TT, Rains JC. Randomized Controlled Pilot Trial of Behavioral Insomnia Treatment for Chronic Migraine With Comorbid Insomnia. Headache. 2016 Feb;56(2):276-91. doi: 10.1111/head.12760. Epub 2016 Jan 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients aged 18-65 diagnosed with chronic migraine (15 or more days with headache per month, most of which must be migraine) and insomnia who present for routine medical care for migraine.

Exclusion Criteria:

  • Currently pregnant or breastfeeding, being unable to read or speak English at a 6th grade level, alcohol or substance abuse or dependence, bipolar disorder or seizure disorder, psychiatric hospitalization within the last year, medication overuse headache, and patients not stable on current migraine medications.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Daniel Riche, University of Mississippi, Oxford
Daniel Riche
  • Migraine Research Foundation
  • The Oxford Neurology Clinic
Principal Investigator: Todd A Smitherman, Ph.D. University of Mississippi Medical Center
University of Mississippi, Oxford
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP