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MigraineBMBCT-MNCT02443519

Bronx MBCT-Migraine

A study testing MBCT for Migraine in people with Migraine, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized clinical trial aims to examine the effect of a standardized 8-week course of Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people with migraine. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
MBCT for Migraine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Jul 2015to Feb 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ICHD-3 beta headache diagnosis of migraine,
  • self-reported and diary-confirmed 4-20 headache days per month
  • aged 18-65
  • ability to read English
  • capacity to consent.

Who cannot join

  • no ICHD-3 beta headache diagnosis of migraine
  • fewer than 4 or greater than 20 headache days per month
  • under 18 or over 65
  • inability to read English
  • lacking the capacity to consent
  • utilization of new preventative pain treatments within four weeks of the baseline assessment, or a plan to utilize new preventive pain medications during the duration of the study
  • severe psychiatric illness that would interfere with participation in the treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yeshiva University

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial

This randomized clinical trial aims to examine the effect of a standardized 8-week course of Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people with migraine.

Conditions
Migraine
Being tested
MBCT for Migraine
Keywords
Mindfulness, MBCT, Cognitive Therapy, Disability
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBCT for MigraineBehavioural

    8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework

Study groups in NCT02443519
Study groupRoleWhat they receive
MBCT for MigraineExperimentalIn this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day \& Thorn). Participants will attend weekly 75-90 minute individual sessions for eight weeks. At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain). Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc). Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.
Receives: Behavioral: MBCT for Migraine
Wait List/Treatment as UsualNo interventionPatients will continue with standard care. Patients will be offered MBCT after the primary endpoint.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of People With "Severe" Scores on the Migraine Disability Assessment

    The MIDAS is a 5-item, self-report instrument that assesses the number of days in the past three months participants experienced partially or fully reduced functioning in a variety of contexts (work, school, social). MIDAS scores are totaled and interpreted in the following grades: 0-5 = Grade I (Little or no disability); 6-10 = Grade II (Mild disability); 11-20 = Grade III (Moderate disability); 21+ = Grade IV (Severe disability). Scores were dichotomized at "Not Severe" (Grades I, II, and III) and "Severe "(Grade IV). The outcome was the proportion of participants who reported "Severe Disability."

    Measured: Change from Month 1 to Month 4

  2. Headache-Related Disability Index

    25-item, self-report questionnaire of the emotional and functional impact of headache on daily activities. Total scores range from 0-100, with higher scores indicating higher levels of disability.

    Measured: Change from Month 1 to Month 4

Secondary outcomes (10)

  1. Headache Days (Over Course of 1 Month)

    Number of headache days/month for the month prior to treatment, and the month after treatment

    Measured: Change from Month 1 to Month 4

  2. Average Headache Severity for Headache Days Recorded Over 30 Days

    Headache Severity was recorded for every headache day on a scale of 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Average headache severity was averaged across all headache days for each month.

    Measured: Change from Month 1 to Month 4

  3. The Pain Catastrophizing Scale

    13-item self-report measure that conveys a participant's level of pain-related, catastrophic thinking during painful experiences. Total scores range from 0-52, with higher scores indicating higher levels of catastrophizing.

    Measured: Change from Month 1 to Month 4

  4. Chronic Pain Acceptance Questionnaire

    20-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance.

    Measured: Change from Month 1 to Month 4

  5. Five Facet Mindfulness Questionnaire

    39-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.

    Measured: Change from Month 1 to Month 4

  6. Headache Specific Locus of Control

    33-item measure designed to assess the extent to which individuals with recurrent headaches expect that the occurrence, worsening, and improvement of their headaches are influenced primarily by their own behavior, by chance or fate, or by the actions of medical professionals. Total scores range from 33-165, with higher scores indicating more external (vs. internal) locus of control.

    Measured: Change from Month 1 to Month 4

  7. Headache Management Self-efficacy Scale

    25-item self-report scale designed to capture the confidence a patient believes they have in their own abilities to prevent headache episodes and manage their pain. Total scores range from 25-175, with higher scores indicating higher levels of self-efficacy

    Measured: Change from Month 1 to Month 4

  8. NIH PROMIS Depression Short Form

    8-item self-report measure that assesses emotional distress in the past week focusing on negative mood and negative self-views. Scores are normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of depressive symptoms.

    Measured: Change from Month 1 to Month 4

  9. NIH PROMIS Anxiety Short Form

    8-item self-report measure that assesses emotional distress in the past week focusing on fear, worry and hyper-arousal. Scores were normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of anxious symptoms.

    Measured: Change from Month 1 to Month 4

  10. Average Monthly Migraine Disability Index

    A daily 4-item measure of migraine related disability. Scores range from 0-10, with higher scores indicating higher levels of disability. Scores are averaged across all headache days recorded each month.

    Measured: Change from Month 1 through Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionOct 2018
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02443519
Sponsor's protocol ID
2015-4684
Acronym
BMBCT-M
Status last verified
Sep 2020
First submitted
8 May 2015
Last updated
12 Oct 2020
Data monitoring committee
Yes

Publications

  • Best RD, Ozmeral A, Grinberg AS, Smitherman TA, Seng EK. Pain acceptance as a change mechanism for mindfulness-based cognitive therapy for migraine. J Behav Med. 2024 Jun;47(3):471-482. doi: 10.1007/s10865-024-00475-5. Epub 2024 Feb 26.

    PubMed 38407727

  • Seng EK, Conway AB, Grinberg AS, Patel ZS, Marzouk M, Rosenberg L, Metts C, Day MA, Minen MT, Buse DC, Lipton RB. Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. Neurol Clin Pract. 2021 Jun;11(3):194-205. doi: 10.1212/CPJ.0000000000000984.

    PubMed 34484887

Questions about this trial

What is this clinical trial studying?

A study testing MBCT for Migraine in people with Migraine, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of People With "Severe" Scores on the Migraine Disability Assessment (time frame: Change from Month 1 to Month 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02443519, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020; AzTrials last refreshed its copy on 28 Oct 2026.

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