Bronx MBCT-Migraine
- Conditions
- Migraine
- Interventions
- Behavioral: MBCT for Migraine
- Registration Number
- NCT02443519
- Lead Sponsor
- Albert Einstein College of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MBCT for Migraine 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.
- Primary Outcome Measures
Name Time Method 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.
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."
- Secondary Outcome Measures
Name Time Method 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.
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.
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 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
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.
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
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.
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.
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.
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.
Trial Locations
- Locations (1)
Yeshiva University
🇺🇸Bronx, New York, United States