Migraine
Conditions
Keywords
Mindfulness, MBCT, Cognitive Therapy, Disability
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.
Interventions
BEHAVIORALMBCT for Migraine
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
Sponsors
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of People With Severe Scores on the Migraine Disability Assessment | Change from Month 1 to Month 4 | 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 | Change from Month 1 to Month 4 | 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
| Measure | Time frame | Description |
|---|---|---|
| The Pain Catastrophizing Scale | Change from Month 1 to Month 4 | 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 | Change from Month 1 to Month 4 | 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 | Change from Month 1 to Month 4 | 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 | Change from Month 1 to Month 4 | 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 Days (Over Course of 1 Month) | Change from Month 1 to Month 4 | Number of headache days/month for the month prior to treatment, and the month after treatment |
| NIH PROMIS Depression Short Form | Change from Month 1 to Month 4 | 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 | Change from Month 1 to Month 4 | 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 | Change from Month 1 through Month 4 | 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. |
| Headache Management Self-efficacy Scale | Change from Month 1 to Month 4 | 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 |
| Average Headache Severity for Headache Days Recorded Over 30 Days | Change from Month 1 to Month 4 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| Wait List/Treatment as Usual Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint. | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | MBCT for Migraine | Wait List/Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 10.6 | 44.2 years STANDARD_DEVIATION 11.5 | 40.1 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 24 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Headache Day Frequency (>=15 days/30 days) < 15 days/month | 15 Participants | 14 Participants | 29 Participants |
| Headache Day Frequency (>=15 days/30 days) >= 15 days/month | 16 Participants | 15 Participants | 31 Participants |
| Headache Disability Inventory (HDI) | 52.5 units on a scale STANDARD_DEVIATION 21.2 | 50.2 units on a scale STANDARD_DEVIATION 16.2 | 51.4 units on a scale STANDARD_DEVIATION 19 |
| Migraine Disability Assessment (MIDAS) Score >=21 MIDAS Not Severe (Score < 21) | 7 Participants | 3 Participants | 10 Participants |
| Migraine Disability Assessment (MIDAS) Score >=21 MIDAS Severe (Score >=21) | 24 Participants | 26 Participants | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 26 Participants | 23 Participants | 49 Participants |
| Region of Enrollment United States | 31 participants | 29 participants | 60 participants |
| Sex: Female, Male Female | 29 Participants | 26 Participants | 55 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 2 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | Headache-Related Disability Index | Month 1 | 52.5 score on a scale | Standard Deviation 21.2 |
| MBCT for Migraine | Headache-Related Disability Index | Month 4 | 38.2 score on a scale | Standard Deviation 16.6 |
| Wait List/Treatment as Usual | Headache-Related Disability Index | Month 1 | 50.2 score on a scale | Standard Deviation 16.2 |
| Wait List/Treatment as Usual | Headache-Related Disability Index | Month 4 | 50.4 score on a scale | Standard Deviation 14.3 |
p-value: <0.00495% CI: [0.8, 21.8]Mixed Models Analysis
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MBCT for Migraine | Proportion of People With Severe Scores on the Migraine Disability Assessment | Month 4 | 58.1 percentage of participants |
| MBCT for Migraine | Proportion of People With Severe Scores on the Migraine Disability Assessment | Month 1 | 77.4 percentage of participants |
| Wait List/Treatment as Usual | Proportion of People With Severe Scores on the Migraine Disability Assessment | Month 1 | 89.7 percentage of participants |
| Wait List/Treatment as Usual | Proportion of People With Severe Scores on the Migraine Disability Assessment | Month 4 | 75.9 percentage of participants |
p-value: 0.02795% CI: [-0.7, 3.9]Mixed Models Analysis
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | Average Headache Severity for Headache Days Recorded Over 30 Days | Month 1 | 1.7 units on a scale | Standard Deviation 0.3 |
| MBCT for Migraine | Average Headache Severity for Headache Days Recorded Over 30 Days | Month 4 | 1.6 units on a scale | Standard Deviation 0.3 |
| Wait List/Treatment as Usual | Average Headache Severity for Headache Days Recorded Over 30 Days | Month 1 | 1.8 units on a scale | Standard Deviation 0.3 |
| Wait List/Treatment as Usual | Average Headache Severity for Headache Days Recorded Over 30 Days | Month 4 | 1.7 units on a scale | Standard Deviation 0.3 |
p-value: 0.88895% CI: [-0.14, 0.16]Mixed Models Analysis
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.
Time frame: Change from Month 1 through Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | Average Monthly Migraine Disability Index | Month 1 | 2.8 score on a scale | Standard Deviation 1.6 |
| MBCT for Migraine | Average Monthly Migraine Disability Index | Month 4 | 1.7 score on a scale | Standard Deviation 2.7 |
| Wait List/Treatment as Usual | Average Monthly Migraine Disability Index | Month 1 | 3.4 score on a scale | Standard Deviation 2 |
| Wait List/Treatment as Usual | Average Monthly Migraine Disability Index | Month 4 | 4.4 score on a scale | Standard Deviation 1.3 |
p-value: 0.00795% CI: [-1.6, -0.3]Mixed Models Analysis
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | Chronic Pain Acceptance Questionnaire | Month 1 | 60.7 score on a scale | Standard Deviation 20.2 |
| MBCT for Migraine | Chronic Pain Acceptance Questionnaire | Month 4 | 68.0 score on a scale | Standard Deviation 9.2 |
| Wait List/Treatment as Usual | Chronic Pain Acceptance Questionnaire | Month 1 | 60.3 score on a scale | Standard Deviation 14 |
| Wait List/Treatment as Usual | Chronic Pain Acceptance Questionnaire | Month 4 | 64.7 score on a scale | Standard Deviation 7.8 |
p-value: 0.57295% CI: [-10.83, 4.74]Mixed Models Analysis
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | Five Facet Mindfulness Questionnaire | Month 1 | 128.5 score on a scale | Standard Deviation 17.6 |
| MBCT for Migraine | Five Facet Mindfulness Questionnaire | Month 4 | 116.0 score on a scale | Standard Deviation 8.6 |
| Wait List/Treatment as Usual | Five Facet Mindfulness Questionnaire | Month 1 | 132.9 score on a scale | Standard Deviation 18.3 |
| Wait List/Treatment as Usual | Five Facet Mindfulness Questionnaire | Month 4 | 117.7 score on a scale | Standard Deviation 10.9 |
p-value: 0.60995% CI: [-11.76, 6.46]Mixed Models Analysis
Secondary
Headache Days (Over Course of 1 Month)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | Headache Days (Over Course of 1 Month) | Month 1 | 16.5 Days/30 days | Standard Deviation 6 |
| MBCT for Migraine | Headache Days (Over Course of 1 Month) | Month 4 | 14.8 Days/30 days | Standard Deviation 4.8 |
| Wait List/Treatment as Usual | Headache Days (Over Course of 1 Month) | Month 1 | 15.5 Days/30 days | Standard Deviation 5.9 |
| Wait List/Treatment as Usual | Headache Days (Over Course of 1 Month) | Month 4 | 14.2 Days/30 days | Standard Deviation 4.8 |
p-value: 0.77395% CI: [-3.7, 2.8]Mixed Models Analysis
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
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | Headache Management Self-efficacy Scale | Month 1 | 108.1 score on a scale | Standard Deviation 11.9 |
| MBCT for Migraine | Headache Management Self-efficacy Scale | Month 4 | 113.8 score on a scale | Standard Deviation 12.6 |
| Wait List/Treatment as Usual | Headache Management Self-efficacy Scale | Month 1 | 111.8 score on a scale | Standard Deviation 13.5 |
| Wait List/Treatment as Usual | Headache Management Self-efficacy Scale | Month 4 | 115.4 score on a scale | Standard Deviation 11.1 |
p-value: 0.12495% CI: [-7.56, 3.53]Mixed Models Analysis
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | Headache Specific Locus of Control | Month 1 | 86.0 score on a scale | Standard Deviation 10.5 |
| MBCT for Migraine | Headache Specific Locus of Control | Month 4 | 80.3 score on a scale | Standard Deviation 11.8 |
| Wait List/Treatment as Usual | Headache Specific Locus of Control | Month 1 | 87.5 score on a scale | Standard Deviation 14.3 |
| Wait List/Treatment as Usual | Headache Specific Locus of Control | Month 4 | 89.8 score on a scale | Standard Deviation 17.1 |
p-value: 0.02295% CI: [2.99, 13.91]Mixed Models Analysis
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | NIH PROMIS Anxiety Short Form | Month 1 | 56.7 score on a scale | Standard Deviation 8.2 |
| MBCT for Migraine | NIH PROMIS Anxiety Short Form | Month 4 | 55.7 score on a scale | Standard Deviation 8.1 |
| Wait List/Treatment as Usual | NIH PROMIS Anxiety Short Form | Month 1 | 56.2 score on a scale | Standard Deviation 6.2 |
| Wait List/Treatment as Usual | NIH PROMIS Anxiety Short Form | Month 4 | 59.2 score on a scale | Standard Deviation 7.7 |
p-value: 0.25995% CI: [-0.03, 5.68]Mixed Models Analysis
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | NIH PROMIS Depression Short Form | Month 1 | 54.0 score on a scale | Standard Deviation 60.2 |
| MBCT for Migraine | NIH PROMIS Depression Short Form | Month 4 | 52.2 score on a scale | Standard Deviation 6.8 |
| Wait List/Treatment as Usual | NIH PROMIS Depression Short Form | Month 1 | 53.1 score on a scale | Standard Deviation 7.4 |
| Wait List/Treatment as Usual | NIH PROMIS Depression Short Form | Month 4 | 55.9 score on a scale | Standard Deviation 6.5 |
p-value: 0.01795% CI: [0.63, 6.33]Mixed Models Analysis
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.
Time frame: Change from Month 1 to Month 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBCT for Migraine | The Pain Catastrophizing Scale | Month 1 | 22.6 score on a scale | Standard Deviation 8.7 |
| MBCT for Migraine | The Pain Catastrophizing Scale | Month 4 | 15.6 score on a scale | Standard Deviation 8.8 |
| Wait List/Treatment as Usual | The Pain Catastrophizing Scale | Month 1 | 22.0 score on a scale | Standard Deviation 7.8 |
| Wait List/Treatment as Usual | The Pain Catastrophizing Scale | Month 4 | 22.6 score on a scale | Standard Deviation 10.4 |
p-value: 0.03595% CI: [2.48, 12.42]Mixed Models Analysis