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Completed

NCT Number: NCT02443519

Bronx MBCT-Migraine

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeshiva University

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBCT for Migraine

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Official study title

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

Acronym: BMBCT-M

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 14, 2015
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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