NCT01545466

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

February 24, 2012

Last Update Submit

March 11, 2013

Conditions

MigraineHeadache

Keywords

MigrainesBehavioralComplementary and Alternative MedicineMindfulness MeditationMindfulness Based Stress Reduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Change in self-efficacy from baseline

    baseline, immediately post-intervention, 4 weeks post-intervention

  • Change in perceived stress from baseline

    baseline, immediately post-intervention, 4 weeks post-intervention

  • Change in migraine-related disability/impact from baseline

    baseline, immediately post-intervention, 4 weeks post-intervention

  • Change in anxiety from baseline

    baseline, immediately post-intervention, 4 weeks post-intervention

  • Change in depression from baseline

    baseline, immediately post-intervention, 4 weeks post-intervention

  • +5 more secondary outcomes

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

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)

Wait-List Control Group

NO INTERVENTION

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

Interventions

Mindfulness Based Stress Reduction (MBSR)BEHAVIORAL

MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class

Mindfulness Based Stress Reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of migraine (International Classification of Headache Disorders-II);21
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Wells RE, Burch R, Paulsen RH, Wayne PM, Houle TT, Loder E. Meditation for migraines: a pilot randomized controlled trial. Headache. 2014 Oct;54(9):1484-95. doi: 10.1111/head.12420. Epub 2014 Jul 18.

    PMID: 25041058DERIVED

MeSH Terms

Conditions

Migraine DisordersHeadacheBehavior

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rebecca E Wells, MD, MPH

    Brigham and Women's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 6, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

US(1)