Clinical trial NCT01314651: Efficacy of Behavioral Insomnia Treatment for Chronic Migraine
Official title: Efficacy of Behavioral Insomnia Treatment for Chronic Migraine: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Insomnia
Keywords: Migraine Disorders
Chronic migraine
Insomnia
Behavioral sleep management
Lead sponsor: University of Mississippi, Oxford
Sponsor class: OTHER
Collaborators: name: Migraine Research Foundation
name: The Oxford Neurology Clinic
First posted: 2011-03-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Headache frequency
timeFrame: 2 weeks post-treatment, 6 weeks post-treatment
Secondary outcomes:
measure: Headache severity
timeFrame: 2 weeks post-treatment, 6 weeks post-treatment
measure: Headache-related disability
timeFrame: 2 weeks post-treatment; 6 weeks post-treatment
measure: Total Sleep Time
timeFrame: 2 weeks post-treatment; 6 weeks post-treatment
Other outcomes:
Locations:
city: University
country: United States
facility: Psychological Services Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Todd A Smitherman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.