Clinical trial NCT02443519: Bronx MBCT-Migraine
Official title: Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Mindfulness
MBCT
Cognitive Therapy
Disability
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of People With "Severe" Scores on the Migraine Disability Assessment
timeFrame: Change from Month 1 to Month 4
measure: Headache-Related Disability Index
timeFrame: Change from Month 1 to Month 4
Secondary outcomes:
measure: Headache Days (Over Course of 1 Month)
timeFrame: Change from Month 1 to Month 4
measure: Average Headache Severity for Headache Days Recorded Over 30 Days
timeFrame: Change from Month 1 to Month 4
measure: The Pain Catastrophizing Scale
timeFrame: Change from Month 1 to Month 4
measure: Chronic Pain Acceptance Questionnaire
timeFrame: Change from Month 1 to Month 4
measure: Five Facet Mindfulness Questionnaire
timeFrame: Change from Month 1 to Month 4
measure: Headache Specific Locus of Control
timeFrame: Change from Month 1 to Month 4
measure: Headache Management Self-efficacy Scale
timeFrame: Change from Month 1 to Month 4
measure: NIH PROMIS Depression Short Form
timeFrame: Change from Month 1 to Month 4
measure: NIH PROMIS Anxiety Short Form
timeFrame: Change from Month 1 to Month 4
measure: Average Monthly Migraine Disability Index
timeFrame: Change from Month 1 through Month 4
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Yeshiva University
state: New York
Study officials:
affiliation: Yeshiva University/Albert Einstein College of Medicine
name: Elizabeth K Seng, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.