Efficacy of Behavioral Insomnia Treatment for Chronic Migraine
Condition: Chronic Migraine; Insomnia
MeSH terms: Migraine Disorders; Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Stimulus Control and Sleep Restriction; Lifestyle Modification
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 instructions in stimulus control and individually-tailored sleep restriction; 5 instructions in changing general lifestyle habits (maintaining consistent liquid intake, range of motion exercises, eating a serving of protein in the morning, etc.)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine Disorders; Chronic migraine; Insomnia; Behavioral sleep management