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Bronx MBCT-Migraine (BMBCT-M)

This study is currently recruiting participants.
Verified October 2016 by Elizabeth Seng, Albert Einstein College of Medicine of Yeshiva University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02443519
First Posted: May 14, 2015
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Elizabeth Seng, Albert Einstein College of Medicine of Yeshiva University
  Purpose
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.

Condition Intervention
Migraine Behavioral: MBCT for Migraine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Elizabeth Seng, Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Migraine Disability Assessment [ Time Frame: Change from Month 1 to Month 4 ]
    5-item, self-report instrument measuring disruption experienced due to migraine

  • Headache-Related Disability Index [ Time Frame: Change from Month 1 to Month 4 ]
    25-item, self-report questionnaire of the emotional and functional impact of headache on daily activities


Secondary Outcome Measures:
  • Headache Days (over course of 1 month) [ Time Frame: Change from Month 1 to Month 4 ]
    Number of headache days/month for the month prior to treatment, and the month after treatment

  • Headache Severity (average of severity over course of 1 month) [ Time Frame: Change from Month 1 to Month 4 ]
    Average headache severity for one month prior to treatment, and the month after treatment ends

  • The Pain Catastrophizing Scale [ Time Frame: Change from Month 1 to Month 4 ]
    13-item self-report measure that conveys a participant's level of pain-related, catastrophic thinking during painful experiences

  • Chronic Pain Acceptance Questionnaire [ Time Frame: Change from Month 1 to Month 4 ]
    20-item, self-report measure of pain-related acceptance

  • Five Facet Mindfulness Questionnaire [ Time Frame: Change from Month 1 to Month 4 ]
    39-item self-report instrument containing five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience

  • Headache Specific Locus of Control [ Time Frame: Change from Month 1 to Month 4 ]
    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.

  • Headache Management Self-efficacy Scale [ Time Frame: Change from Month 1 to Month 4 ]
    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

  • NIH PROMIS Depression Short Form [ Time Frame: Change from Month 1 to Month 4 ]
    8-item self-report measure that assesses emotional distress in the past week focusing on negative mood and negative self-views

  • NIH PROMIS Anxiety Short Form [ Time Frame: Change from Month 1 to Month 4 ]
    8-item self-report measure that assesses emotional distress in the past week focusing on fear, worry and hyper-arousal.

  • Migraine Disability Index [ Time Frame: Change from Month 1 through Month 4 ]
    A daily 4-item measure of migraine related disability


Estimated Enrollment: 80
Study Start Date: May 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBCT for Migraine
In 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.
Behavioral: MBCT for Migraine
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
No Intervention: Wait List/Treatment as Usual
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443519


Contacts
Contact: Elizabeth K Seng, Ph.D. 718-430-3813 Elizabeth.Seng@einstein.yu.edu

Locations
United States, New York
Yeshiva University Recruiting
Bronx, New York, United States, 10461
Contact: Elizabeth Seng, Ph.D.    929-224-3984    MBCTforHeadache@gmail.com   
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Investigators
Principal Investigator: Elizabeth K Seng, Ph.D. Yeshiva University/Albert Einstein College of Medicine
  More Information

Responsible Party: Elizabeth Seng, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT02443519     History of Changes
Other Study ID Numbers: 2015-4684
First Submitted: May 8, 2015
First Posted: May 14, 2015
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Elizabeth Seng, Albert Einstein College of Medicine of Yeshiva University:
Mindfulness
MBCT
Cognitive Therapy
Disability

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases