Bronx MBCT-Migraine (BMBCT-M)

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Behavioral: MBCT for Migraine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Yeshiva University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of People With "Severe" Scores on the Migraine Disability Assessment	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."	Change from Month 1 to Month 4
Headache-Related Disability Index	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.	Change from Month 1 to Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Days (Over Course of 1 Month)	Number of headache days/month for the month prior to treatment, and the month after treatment	Change from Month 1 to Month 4
Average Headache Severity for Headache Days Recorded Over 30 Days	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.	Change from Month 1 to Month 4
The Pain Catastrophizing Scale	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.	Change from Month 1 to Month 4
Chronic Pain Acceptance Questionnaire	20-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance.	Change from Month 1 to Month 4
Five Facet Mindfulness Questionnaire	39-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.	Change from Month 1 to Month 4
Headache Specific Locus of Control	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.	Change from Month 1 to Month 4
Headache Management Self-efficacy Scale	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	Change from Month 1 to Month 4
NIH PROMIS Depression Short Form	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.	Change from Month 1 to Month 4
NIH PROMIS Anxiety Short Form	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.	Change from Month 1 to Month 4
Average Monthly Migraine Disability Index	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.	Change from Month 1 through Month 4

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Mindfulness; Disability; Cognitive Therapy; MBCT
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 2015-4684