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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBCT for Migraine | Experimental | 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. |
|
| Wait List/Treatment as Usual | No Intervention | Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBCT for Migraine | Behavioral | 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth K Seng, Ph.D. | Yeshiva University/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeshiva University | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38407727 | Derived | Best RD, Ozmeral A, Grinberg AS, Smitherman TA, Seng EK. Pain acceptance as a change mechanism for mindfulness-based cognitive therapy for migraine. J Behav Med. 2024 Jun;47(3):471-482. doi: 10.1007/s10865-024-00475-5. Epub 2024 Feb 26. | |
| 34484887 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. MBCT for Migraine: 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework |
| FG001 | Wait List/Treatment as Usual | Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. MBCT for Migraine: 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Posted | Number | percentage of participants | Change from Month 1 to Month 4 |
|
4 months
Adverse events were tracked on a monthly basis by research staff in both groups. Participants in the MBCT-M group were also tracked weekly by the study therapist during the two-month treatment period (Month 2 and Month 3).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. MBCT for Migraine: 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flooding | Psychiatric disorders | Non-systematic Assessment | A vivid recollection of a traumatic event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Seng | Yeshiva University & Albert Einstein College of Medicine | 646-592-4368 | elizabeth.seng@yu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2019 | Nov 26, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2018 | Jan 9, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
| BG001 | Wait List/Treatment as Usual | Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Headache Disability Inventory (HDI) | The HDI is a scale that ranges from 0-100, with higher scores indicating higher levels of headache disability. | Mean | Standard Deviation | units on a scale |
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| Migraine Disability Assessment (MIDAS) Score >=21 | The MIDAS is a scale 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). | Count of Participants | Participants |
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| Headache Day Frequency (>=15 days/30 days) | Count of Participants | Participants |
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| OG001 | Wait List/Treatment as Usual | Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint. |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 to Month 4 |
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| Secondary | Headache Days (Over Course of 1 Month) | Number of headache days/month for the month prior to treatment, and the month after treatment | Posted | Mean | Standard Deviation | Days/30 days | Change from Month 1 to Month 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Month 1 to Month 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 to Month 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 to Month 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 to Month 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 to Month 4 |
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| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 to Month 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 to Month 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 to Month 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from Month 1 through Month 4 |
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| 0 |
| 31 |
| 0 |
| 31 |
| 2 |
| 31 |
| EG001 | Wait List/Treatment as Usual | Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Increase in headache frequency and intensity | Nervous system disorders | Non-systematic Assessment | Sudden and severe increase in headache frequency and intensity |
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| D009422 | Nervous System Diseases |