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.
Brief Title
Bronx MBCT-Migraine
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
Eligibility 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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Mindfulness
MBCT
Cognitive Therapy
Disability
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT02443519
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2015-4684
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial
Primary Outcomes
Outcome Description
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."
Outcome Measure
Proportion of People With "Severe" Scores on the Migraine Disability Assessment
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Description
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.
Outcome Measure
Headache-Related Disability Index
Outcome Time Frame
Change from Month 1 to Month 4
Secondary Outcomes
Outcome Description
Number of headache days/month for the month prior to treatment, and the month after treatment
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
Headache Days (Over Course of 1 Month)
Outcome Description
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.
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
Average Headache Severity for Headache Days Recorded Over 30 Days
Outcome Description
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.
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
The Pain Catastrophizing Scale
Outcome Description
20-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance.
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
Chronic Pain Acceptance Questionnaire
Outcome Description
39-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
Five Facet Mindfulness Questionnaire
Outcome Description
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.
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
Headache Specific Locus of Control
Outcome Description
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
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
Headache Management Self-efficacy Scale
Outcome Description
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.
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
NIH PROMIS Depression Short Form
Outcome Description
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.
Outcome Time Frame
Change from Month 1 to Month 4
Outcome Measure
NIH PROMIS Anxiety Short Form
Outcome Description
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.
Outcome Time Frame
Change from Month 1 through Month 4
Outcome Measure
Average Monthly Migraine Disability Index
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Elizabeth Seng
Investigator Email
elizabeth.seng@einsteinmed.org
Investigator Phone