Bronx MBCT-Migraine (BMBCT-M)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02443519|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2015
Last Update Posted : October 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Behavioral: MBCT for Migraine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: 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.
Behavioral: MBCT for Migraine
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
No Intervention: Wait List/Treatment as Usual
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
- Migraine Disability Assessment [ Time Frame: Change from Month 1 to Month 4 ]5-item, self-report instrument measuring disruption experienced due to migraine
- 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
- Headache Days (over course of 1 month) [ Time Frame: Change from Month 1 to Month 4 ]Number of headache days/month for the month prior to treatment, and the month after treatment
- Headache Severity (average of severity over course of 1 month) [ Time Frame: Change from Month 1 to Month 4 ]Average headache severity for one month prior to treatment, and the month after treatment ends
- The Pain Catastrophizing Scale [ Time Frame: 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
- Chronic Pain Acceptance Questionnaire [ Time Frame: Change from Month 1 to Month 4 ]20-item, self-report measure of pain-related acceptance
- Five Facet Mindfulness Questionnaire [ Time Frame: Change from Month 1 to Month 4 ]39-item self-report instrument containing five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience
- Headache Specific Locus of Control [ Time Frame: 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.
- Headache Management Self-efficacy Scale [ Time Frame: 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
- NIH PROMIS Depression Short Form [ Time Frame: 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
- NIH PROMIS Anxiety Short Form [ Time Frame: 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.
- Migraine Disability Index [ Time Frame: Change from Month 1 through Month 4 ]A daily 4-item measure of migraine related disability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443519
|United States, New York|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Elizabeth K Seng, Ph.D.||Yeshiva University/Albert Einstein College of Medicine|