Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- Albert Einstein College of Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Headache-Related Disability Index
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Elizabeth Seng
Assistant Professor
Albert Einstein College of Medicine
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
Outcomes
Primary Outcomes
Headache-Related Disability Index
Time Frame: 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.
Proportion of People With "Severe" Scores on the Migraine Disability Assessment
Time Frame: 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."
Secondary Outcomes
- Average Headache Severity for Headache Days Recorded Over 30 Days(Change from Month 1 to Month 4)
- The Pain Catastrophizing Scale(Change from Month 1 to Month 4)
- Five Facet Mindfulness Questionnaire(Change from Month 1 to Month 4)
- Headache Management Self-efficacy Scale(Change from Month 1 to Month 4)
- NIH PROMIS Depression Short Form(Change from Month 1 to Month 4)
- Headache Days (Over Course of 1 Month)(Change from Month 1 to Month 4)
- Chronic Pain Acceptance Questionnaire(Change from Month 1 to Month 4)
- Headache Specific Locus of Control(Change from Month 1 to Month 4)
- Average Monthly Migraine Disability Index(Change from Month 1 through Month 4)
- NIH PROMIS Anxiety Short Form(Change from Month 1 to Month 4)