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Efficacy of Behavioral Insomnia Treatment for Chronic Migraine

This study has been completed.
Sponsor:
Collaborators:
Migraine Research Foundation
The Oxford Neurology Clinic
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi, Oxford
ClinicalTrials.gov Identifier:
NCT01314651
First received: March 11, 2011
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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 Intervention
Chronic Migraine
Insomnia
Behavioral: Stimulus Control and Sleep Restriction
Behavioral: Lifestyle Modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Behavioral Insomnia Treatment for Chronic Migraine: A Randomized Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Mississippi, Oxford:

Primary Outcome Measures:
  • Headache frequency [ Time Frame: 2 weeks post-treatment, 6 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache severity [ Time Frame: 2 weeks post-treatment, 6 weeks post-treatment ] [ Designated as safety issue: No ]
  • Headache-related disability [ Time Frame: 2 weeks post-treatment; 6 weeks post-treatment ] [ Designated as safety issue: No ]
  • Total Sleep Time [ Time Frame: 2 weeks post-treatment; 6 weeks post-treatment ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314651

Locations
United States, Mississippi
Psychological Services Center
University, Mississippi, United States, 38677
Sponsors and Collaborators
Daniel Riche
Migraine Research Foundation
The Oxford Neurology Clinic
Investigators
Principal Investigator: Todd A Smitherman, Ph.D. University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: Daniel Riche, University of Mississippi Clinical Trials and FDA Administrator, University of Mississippi, Oxford
ClinicalTrials.gov Identifier: NCT01314651     History of Changes
Other Study ID Numbers: UMO-0002
Study First Received: March 11, 2011
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi, Oxford:
Migraine Disorders
Chronic migraine
Insomnia
Behavioral sleep management

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014