COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 2 of 8 for:    lifestyle | Migraine | United States

Efficacy of Behavioral Insomnia Treatment for Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314651
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : April 24, 2014
Migraine Research Foundation
The Oxford Neurology Clinic
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi, Oxford

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Insomnia Behavioral: Stimulus Control and Sleep Restriction Behavioral: Lifestyle Modification Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Behavioral Insomnia Treatment for Chronic Migraine: A Randomized Controlled Pilot Study
Study Start Date : March 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Sleep Management
Instructions in stimulus control and sleep restriction.
Behavioral: Stimulus Control and Sleep Restriction
5 instructions in stimulus control and individually-tailored sleep restriction

Sham Comparator: Lifestyle Modification
Instructions to change general lifestyle habits (maintain consistent liquid consumption, range of motion exercises, etc.)
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.)

Primary Outcome Measures :
  1. Headache frequency [ Time Frame: 2 weeks post-treatment, 6 weeks post-treatment ]

Secondary Outcome Measures :
  1. Headache severity [ Time Frame: 2 weeks post-treatment, 6 weeks post-treatment ]
  2. Headache-related disability [ Time Frame: 2 weeks post-treatment; 6 weeks post-treatment ]
  3. Total Sleep Time [ Time Frame: 2 weeks post-treatment; 6 weeks post-treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314651

Layout table for location information
United States, Mississippi
Psychological Services Center
University, Mississippi, United States, 38677
Sponsors and Collaborators
Daniel Riche
Migraine Research Foundation
The Oxford Neurology Clinic
Layout table for investigator information
Principal Investigator: Todd A Smitherman, Ph.D. University of Mississippi Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Daniel Riche, University of Mississippi Clinical Trials and FDA Administrator, University of Mississippi, Oxford Identifier: NCT01314651    
Other Study ID Numbers: UMO-0002
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014
Keywords provided by Daniel Riche, University of Mississippi, Oxford:
Migraine Disorders
Chronic migraine
Behavioral sleep management
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Sleep Initiation and Maintenance Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders