N/A
N=60
Bronx MBCT-Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02443519 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Proportion of People With "Severe" Scores on the Migraine Disability Assessment — 77.4; 89.7; 58.1; 75.9 percentage of participants — p=.027
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MBCT for Migraine (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of People With "Severe" Scores on the Migraine Disability Assessment |
77.4; 89.7; 58.1; 75.9 | .027 sig |
| PRIMARY Headache-Related Disability Index |
52.5; 50.2; 38.2; 50.4 | <.004 sig |
| SECONDARY Headache Days (Over Course of 1 Month) |
16.5; 15.5; 14.8; 14.2 | .773 |
| SECONDARY Average Headache Severity for Headache Days Recorded Over 30 Days |
1.7; 1.8; 1.6; 1.7 | .888 |
| SECONDARY The Pain Catastrophizing Scale |
22.6; 22.0; 15.6; 22.6 | .035 sig |
| SECONDARY Chronic Pain Acceptance Questionnaire |
60.7; 60.3; 68.0; 64.7 | .572 |
| SECONDARY Five Facet Mindfulness Questionnaire |
128.5; 132.9; 116.0; 117.7 | .609 |
| SECONDARY Headache Specific Locus of Control |
86.0; 87.5; 80.3; 89.8 | .022 sig |
| SECONDARY Headache Management Self-efficacy Scale |
108.1; 111.8; 113.8; 115.4 | .124 |
| SECONDARY NIH PROMIS Depression Short Form |
54.0; 53.1; 52.2; 55.9 | .017 sig |
| SECONDARY NIH PROMIS Anxiety Short Form |
56.7; 56.2; 55.7; 59.2 | .259 |
| SECONDARY Average Monthly Migraine Disability Index |
2.8; 3.4; 1.7; 4.4 | .007 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02443519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.