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Bronx MBCT-Migraine (BMBCT-M)

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ClinicalTrials.gov Identifier: NCT02443519
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Elizabeth Seng, Albert Einstein College of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Behavioral: MBCT for Migraine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of People With "Severe" Scores on the Migraine Disability Assessment [ Time Frame: Change from Month 1 to Month 4 ]
    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."

  2. 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. Total scores range from 0-100, with higher scores indicating higher levels of disability.


Secondary Outcome Measures :
  1. 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

  2. Average Headache Severity for Headache Days Recorded Over 30 Days [ Time Frame: Change from Month 1 to Month 4 ]
    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.

  3. 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. Total scores range from 0-52, with higher scores indicating higher levels of catastrophizing.

  4. Chronic Pain Acceptance Questionnaire [ Time Frame: Change from Month 1 to Month 4 ]
    20-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance.

  5. Five Facet Mindfulness Questionnaire [ Time Frame: Change from Month 1 to Month 4 ]
    39-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.

  6. 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. Total scores range from 33-165, with higher scores indicating more external (vs. internal) locus of control.

  7. 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. Total scores range from 25-175, with higher scores indicating higher levels of self-efficacy

  8. 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. Scores are normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of depressive symptoms.

  9. 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. Scores were normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of anxious symptoms.

  10. Average Monthly Migraine Disability Index [ Time Frame: Change from Month 1 through Month 4 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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


Locations
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United States, New York
Yeshiva University
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Elizabeth K Seng, Ph.D. Yeshiva University/Albert Einstein College of Medicine
  Study Documents (Full-Text)

Documents provided by Elizabeth Seng, Albert Einstein College of Medicine:
Study Protocol and Statistical Analysis Plan  [PDF] January 3, 2019
Informed Consent Form  [PDF] February 14, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Elizabeth Seng, Assistant Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02443519    
Other Study ID Numbers: 2015-4684
First Posted: May 14, 2015    Key Record Dates
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020
Last Verified: September 2020
Keywords provided by Elizabeth Seng, Albert Einstein College of Medicine:
Mindfulness
MBCT
Cognitive Therapy
Disability
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases