Non-drug Interventions for Migraines

Mass General Brigham

Status: Completed

Conditions: Migraine; Headache

Treatments: Behavioral: Mindfulness Based Stress Reduction (MBSR)

Study type: Interventional

Funder types: Other

Identifiers

NCT01545466

2011P001654

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Mindfulness Based Stress Reduction

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Based Stress Reduction (MBSR)

Wait-List Control Group

No Intervention group

Description:

These participants will continue in usual care during the trial and will be offered the intervention of MBSR after the trial is over.