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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

Tracking Information
First Submitted Date  ICMJE May 8, 2015
First Posted Date  ICMJE May 14, 2015
Results First Submitted Date  ICMJE November 6, 2019
Results First Posted Date  ICMJE October 12, 2020
Last Update Posted Date October 12, 2020
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • 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."
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bronx MBCT-Migraine
Official Title  ICMJE Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Behavioral: MBCT for Migraine
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: MBCT for Migraine
  • No Intervention: Wait List/Treatment as Usual
    Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
80
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02443519
Other Study ID Numbers  ICMJE 2015-4684
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Seng, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth K Seng, Ph.D. Yeshiva University/Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP