Efficacy of Behavioral Insomnia Treatment for Chronic Migraine

NCT ID: NCT01314651

Last Updated: 2014-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

Chronic Migraine; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep Management

Instructions in stimulus control and sleep restriction.

Group Type: EXPERIMENTAL

Stimulus Control and Sleep Restriction

Intervention Type: BEHAVIORAL

5 instructions in stimulus control and individually-tailored sleep restriction

Lifestyle Modification

Instructions to change general lifestyle habits (maintain consistent liquid consumption, range of motion exercises, etc.)

Group Type: SHAM_COMPARATOR

Lifestyle Modification

Intervention Type: BEHAVIORAL

5 instructions in changing general lifestyle habits (maintaining consistent liquid intake, range of motion exercises, eating a serving of protein in the morning, etc.)

Interventions

Stimulus Control and Sleep Restriction

5 instructions in stimulus control and individually-tailored sleep restriction

Intervention Type: 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.)

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Migraine Research Foundation

OTHER

Sponsor Role: collaborator

The Oxford Neurology Clinic

UNKNOWN

Sponsor Role: collaborator

Daniel Riche

OTHER

Sponsor Role: lead

Responsible Party

Daniel Riche

University of Mississippi Clinical Trials and FDA Administrator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Todd A Smitherman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

Psychological Services Center

University, Mississippi, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26813845 (View on PubMed)

Other Identifiers

UMO-0002

Identifier Type: -

Identifier Source: org_study_id