Bronx MBCT-Migraine

Study Overview
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Brief Summary
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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.

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

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: MBCT for Migraine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT for Migraine<br>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<br>* 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework<br>|
| No Intervention: Wait List/Treatment as Usual<br>Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, MBCT, Cognitive Therapy, Disability