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Bronx MBCT-Migraine (BMBCT-M)

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBCT for Migraine
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Mindfulness, MBCT, Cognitive Therapy, Disability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yeshiva University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBCT for Migraine

Wait List/Treatment as Usual

Arm Description

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.

Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.

Outcomes

Primary Outcome Measures

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."
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.

Secondary Outcome Measures

Headache Days (Over Course of 1 Month)
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
May 8, 2015
Last Updated
September 17, 2020
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02443519
Brief Title
Bronx MBCT-Migraine
Acronym
BMBCT-M
Official Title
Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Mindfulness, MBCT, Cognitive Therapy, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT for Migraine
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List/Treatment as Usual
Arm Type
No Intervention
Arm Description
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
Intervention Type
Behavioral
Intervention Name(s)
MBCT for Migraine
Intervention Description
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
Primary Outcome Measure Information:
Title
Proportion of People With "Severe" Scores on the Migraine Disability Assessment
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."
Time Frame
Change from Month 1 to Month 4
Title
Headache-Related Disability Index
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.
Time Frame
Change from Month 1 to Month 4
Secondary Outcome Measure Information:
Title
Headache Days (Over Course of 1 Month)
Description
Number of headache days/month for the month prior to treatment, and the month after treatment
Time Frame
Change from Month 1 to Month 4
Title
Average Headache Severity for Headache Days Recorded Over 30 Days
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.
Time Frame
Change from Month 1 to Month 4
Title
The Pain Catastrophizing Scale
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.
Time Frame
Change from Month 1 to Month 4
Title
Chronic Pain Acceptance Questionnaire
Description
20-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance.
Time Frame
Change from Month 1 to Month 4
Title
Five Facet Mindfulness Questionnaire
Description
39-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.
Time Frame
Change from Month 1 to Month 4
Title
Headache Specific Locus of Control
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.
Time Frame
Change from Month 1 to Month 4
Title
Headache Management Self-efficacy Scale
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
Time Frame
Change from Month 1 to Month 4
Title
NIH PROMIS Depression Short Form
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.
Time Frame
Change from Month 1 to Month 4
Title
NIH PROMIS Anxiety Short Form
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.
Time Frame
Change from Month 1 to Month 4
Title
Average Monthly Migraine Disability Index
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.
Time Frame
Change from Month 1 through Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth K Seng, Ph.D.
Organizational Affiliation
Yeshiva University/Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeshiva University
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34484887
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.
Results Reference
derived

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Bronx MBCT-Migraine

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