Efficacy of Behavioral Insomnia Treatment for Chronic Migraine
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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 |
- Headache frequency [ Time Frame: 2 weeks post-treatment, 6 weeks post-treatment ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (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 |
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| Contact: Todd A Smitherman, Ph.D. | 662-915-1832 | tasmithe@olemiss.edu |
| United States, Mississippi | |
| Psychological Services Center | Recruiting |
| University, Mississippi, United States, 38677 | |
| Contact: Todd A Smitherman, Ph.D. 662-915-1825 tasmithe@olemiss.edu | |
| Principal Investigator: Todd A Smitherman, Ph.D. | |
| Principal Investigator: | Todd A Smitherman, Ph.D. | University of Mississippi Medical Center |
More Information
No publications provided
| Responsible Party: | Diane W. Lindley, Research Compliance Specialist, 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: | September 12, 2011 |
| 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 Sleep Initiation and Maintenance Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013