View Clinical Trial (Medical Research Study)
Efficacy of Behavioral Insomnia Treatment for Chronic Migraine: A Randomized Controlled Pilot Study
| City: |
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University |
| State: |
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Mississippi |
| Zip Code: |
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38677 |
| Conditions: |
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Chronic Migraine - Insomnia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01314651 |
| Primary Contact: |
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Principal Investigator
Todd A Smitherman, Ph.D.
University of Mississippi Medical Center
Todd A Smitherman, Ph.D.
Phone: 662-915-1832
Email: tasmithe@olemiss.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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University, Mississippi 38677
United States
Todd A Smitherman, Ph.D.
Phone: 662-915-1825
Email: tasmithe@olemiss.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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