Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01314651
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2011-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Behavioral Insomnia Treatment for Chronic Migraine
Sponsor:
Daniel Riche
Organization:
Study Overview
Official Title:
Efficacy of Behavioral Insomnia Treatment for Chronic Migraine: A Randomized Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: