NCT02695498

Brief Summary

Although many adults with migraines use non-pharmacological treatment options, there is a lack of research on the use of many mind/body techniques specifically for headache. This research will further the understanding of the mechanisms, efficacy, and predictors of mind-body practices in adults with migraines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration 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

First Submitted

Initial submission to the registry

January 11, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

August 26, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

November 27, 2023

Completed
Last Updated

November 27, 2023

Status Verified

August 1, 2019

Enrollment Period

2.9 years

First QC Date

January 11, 2016

Results QC Date

October 19, 2021

Last Update Submit

November 22, 2023

Conditions

Migraine

Keywords

migraine with auramigraine without aurapaincontrolsmind-body

Outcome Measures

Primary Outcomes (1)

  • Change in Frequency of Migraine Days Per Month From Baseline

    Change in frequency of migraine days from baseline: A migraine day is defined as a calendar day (00:00 to 23:59) when the patient reports 4 or more continuous hours of a moderate to severe headache (rating of 6-10 on 0-10 pain intensity scale) and/or they treated a headache with abortive medication; tracked with headache logs.

    Baseline and immediately post-intervention (12 weeks)

Secondary Outcomes (39)

  • Change in Frequency of Migraine Days From Baseline

    3 months post-intervention

  • Change in Frequency of Headache Days From Baseline

    Baseline to Immediately post-intervention (12 weeks)

  • Change in Headache Duration From Baseline to 12 Weeks

    From baseline to Immediately post-intervention (12 weeks)

  • Change in Migraine Severity-pain Intensity From Baseline to Week 12

    baseline to Week 12

  • Change in Headache Severity-pain Intensity From Baseline to Week 12

    Baseline and 12 weeks

  • +34 more secondary outcomes

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga.

Other: Mindfulness Based Stress Reduction

Migraine/stress Education

EXPERIMENTAL

This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.

Other: Migraine/stress Education

Interventions

Mindfulness Based Stress ReductionOTHER

MBSR is a standardized course in mindfulness mediation and yoga. The participants will meet weekly for 8 weeks for 2.5 hours, plus a "mindfulness retreat day" (approximately 6 hours) after the 6th class \[9 total classes.\] Mindfulness is cultivated through meditation, body scan (sequential attention to parts of the body), and mindful movement (bodily awareness during gentle stretching, based on yoga). The instructor also gives information about stress and stress relief.

Mindfulness Based Stress Reduction
Migraine/stress EducationOTHER

The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.

Migraine/stress Education

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of migraine; ≥18yo; ≥1 yr of migraines; 4-20 days/month with migraines; able and willing to participate in 8 weekly sessions and daily homework 30-45min

You may not qualify if:

  • Current regular (weekly or more often) practice of meditation; any major unstable medical/psychiatric illness (e.g., hospitalization within 90 days, suicide risk, etc.); other non-migraine chronic pain condition (e.g., fibromyalgia, low back pain, etc.) or sensory abnormalities (e.g., neuropathy, Raynaud's, etc.); diagnosis of medication overuse headache; volunteers with no pain ratings to frankly noxious stimuli (temperatures \> 49°C) or excessive responses to threshold temperatures (\~43°C); current or planned pregnancy or breastfeeding, any new medication started within 4 weeks of screening visit; unwilling to maintain stable current medication dosages for duration of trial; failure to complete baseline headache logs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

  • 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: 25041058BACKGROUND

  • Wells RE, O'Connell N, Pierce CR, Estave P, Penzien DB, Loder E, Zeidan F, Houle TT. Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial. JAMA Intern Med. 2021 Mar 1;181(3):317-328. doi: 10.1001/jamainternmed.2020.7090.

    PMID: 33315046DERIVED

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraMigraine without AuraPain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Rebecca Wells, MD, MPH
Organization
Atrium Health Wake Forest Baptist
rewells@wakehealth.edu
336-716-2357

Study Officials

  • Rebecca E Wells, MD, MPH

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

March 1, 2016

Study Start

August 26, 2016

Primary Completion

July 17, 2019

Study Completion

July 17, 2019

Last Updated

November 27, 2023

Results First Posted

November 27, 2023

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Findings will be disseminated so that providers can implement the results into clinical practice, for scientists to build upon in their research, and for patients to inform treatment decisions. Results will be made publicly available through this website. In addition, results will be published in respected peer-reviewed journals, presented to colleagues at scientific meetings, and discussed with the press.

Shared Documents
STUDY PROTOCOL
Access Criteria
Please contact Dr. Rebecca Wells for information regarding the study protocol and Institutional Review Board (IRB) approvals.

Locations

US(1)