Non-drug Interventions for Migraines

Study Overview
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Brief Summary
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This proposal describes a randomized controlled pilot trial investigating feasibility, safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness based stress reduction (MBSR) program compared to a wait-list control group.

Detailed Description
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Preliminary research has shown MBSR to be effective in chronic pain syndromes and other mind/body interventions have shown good promise in the treatment of headaches. A randomized controlled trial (RCT) of yoga in migraine without aura patients by John and colleagues showed that yoga resulted in a significant decrease in headache frequency, pain index, and symptomatic medication usage compared to a self-care group. This RCT demonstrated that patients with headaches may benefit from a mind-body intervention. However, their yoga protocol was not specified, and participants were instructed to practice the technique only during the prodromal phase of a headache (prior to the pain becoming severe), so as an abortive intervention at the time of a headache. Thus, the investigators of this trial are proposing to evaluate the effect of MBSR on adults with migraines compared to an education control group. This study will add to the John study because, unlike many other mind-body interventions, MBSR offers the distinct advantage of a standardized protocol that has been used both clinically and in numerous research studies across a wide variety of conditions. Furthermore, MBSR teaches participants a daily practice that, if effective, could serve as a prophylactic intervention.

Official Title
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Mindfulness Based Stress Reduction for Adults With Migraines: A Pilot Study

Conditions
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Migraine, Headache

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction (MBSR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of migraine (International Classification of Headache Disorders-II);21 4-14 days with migraines/month ≥one year of migraines ≥18 years Able and willing to attend weekly sessions and willing to participate in daily mindfulness assignments, up to 30-45 min/day Agreeable to participate and to be randomized to either group Fluent in English (since the treatment groups will be run in English) Good general health with no additional diseases expected to interfere with the study Exclusion Criteria: Current regular meditation/yoga practice Any major systemic illness or unstable medical or psychiatric condition (e.g. suicide risk) requiring immediate treatment or that could lead to difficulty complying with the protocol Diagnosis of medication overuse headache (International Classification of Headache Disorders-II);19 Current or planned pregnancy or breastfeeding New prophylactic migraine medicine started within 4 weeks of the screening visit Unwilling to maintain stable current doses of migraine medicines for the duration of trial Failure to complete baseline diary recordings of migraine activity and medication use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Stress Reduction<br>Participants will complete an 8 week course in Mindfulness Based Stress Reduction (MBSR), meeting once/week for 8 weeks and having a 4-6 hour retreat after the 6th class | Behavioral: Mindfulness Based Stress Reduction (MBSR)<br>* MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class<br>|
| No Intervention: Wait-List Control Group<br>These participants will continue in usual care during the trial and will be offered the intervention of MBSR after the trial is over. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Migraine frequency from Baseline | Change in the number of migraines per month from baseline(tracked with headache logs) | baseline, immediately post-intervention, 4 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-efficacy from baseline | Change in self-efficacy from baseline(Headache Management Self-Efficacy Scale) | baseline, immediately post-intervention, 4 weeks post-intervention | 
| Change in perceived stress from baseline | Change in Perceived stress scale from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | 
| Change in migraine-related disability/impact from baseline | Change in migraine-related disability/impact from baseline(one month MIDAS and HIT-6) | baseline, immediately post-intervention, 4 weeks post-intervention | 
| Change in anxiety from baseline | Change in anxiety from baseline (state-trait anxiety measure) | baseline, immediately post-intervention, 4 weeks post-intervention | 
| Change in depression from baseline | Change in depression from baseline(PHQ-9) | baseline, immediately post-intervention, 4 weeks post-intervention | 
| Change in mindfulness from baseline | Change in mindfulness from baseline(Five facet mindfulness scale) | baseline, immediately post-intervention, 4 weeks post-intervention | 
| Qualitative interviews | Participants will be interviewed qualitatively | immediately post-intervention | 
| Change in migraine severity from baseline | Change in Migraine intensity (1-10) tracked via headache logs from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | 
| Change in Migraine duration from baseline | Length of migraines (tracked via headache logs) | baseline, immediately post-intervention, 4 weeks post-intervention | 
| Change in quality of life from baseline | Change in Migraine specific quality of life from baseline | baseline, immediately post-intervention, 4 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraines, Behavioral, Complementary and Alternative Medicine, Mindfulness Meditation, Mindfulness Based Stress Reduction