Non-drug Interventions for Migraines

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545466
• Other study ID #: 2011P001654
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: March 11, 2013
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Mindfulness Based Stress Reduction (MBSR)
MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in perceived stress from baseline	Change in Perceived stress scale from baseline	baseline, immediately post-intervention, 4 weeks post-intervention
Secondary	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
Secondary	Change in anxiety from baseline	Change in anxiety from baseline (state-trait anxiety measure)	baseline, immediately post-intervention, 4 weeks post-intervention
Secondary	Change in depression from baseline	Change in depression from baseline(PHQ-9)	baseline, immediately post-intervention, 4 weeks post-intervention
Secondary	Change in mindfulness from baseline	Change in mindfulness from baseline(Five facet mindfulness scale)	baseline, immediately post-intervention, 4 weeks post-intervention
Secondary	Qualitative interviews	Participants will be interviewed qualitatively	immediately post-intervention
Secondary	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
Secondary	Change in Migraine duration from baseline	Length of migraines (tracked via headache logs)	baseline, immediately post-intervention, 4 weeks post-intervention
Secondary	Change in quality of life from baseline	Change in Migraine specific quality of life from baseline	baseline, immediately post-intervention, 4 weeks post-intervention