Efficacy of Behavioral Insomnia Treatment for Chronic Migraine

Insomnia Clinical Trial

Official title:

Efficacy of Behavioral Insomnia Treatment for Chronic Migraine: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314651
• Other study ID #: UMO-0002
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: April 22, 2014
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: University of Mississippi, Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Migraine
• Insomnia
• Migraine Disorders

Intervention

Behavioral:
• Stimulus Control and Sleep Restriction
5 instructions in stimulus control and individually-tailored sleep restriction
• 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.)

Locations

Country	Name	City	State
United States	Psychological Services Center	University	Mississippi

Sponsors (3)

Lead Sponsor	Collaborator
Daniel Riche	Migraine Research Foundation, The Oxford Neurology Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache frequency		2 weeks post-treatment, 6 weeks post-treatment	No
Secondary	Headache severity		2 weeks post-treatment, 6 weeks post-treatment	No
Secondary	Headache-related disability		2 weeks post-treatment; 6 weeks post-treatment	No
Secondary	Total Sleep Time		2 weeks post-treatment; 6 weeks post-treatment	No