Back to resultsBe WELL With Migraine: Brain Education and WELLness With Migraine
Primary Purpose
Migraine
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Education and WELLness with Migraine Group A
Brain Education and WELLness with Migraine Group B
Sponsored by
About this trial
This is an interventional supportive care trial for Migraine focused on measuring Migraine, Migraine without aura, Migraine with aura, behavioral, mind-body, integrative, virtual, online
Eligibility Criteria
Inclusion Criteria: Diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month At least 1 year of migraine At least 18 years old Able to participate in 8 weekly online classes Willingness to complete baseline headache logs Headache-related disability (Headache Impact Test (HIT)-6) score >50 Fluent in English Completion of technology onboarding with the online platform Pregnant women who are less than or equal to 16 weeks gestation at enrollment are allowed to participate Exclusion Criteria: Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment. Medication overuse headache, with migraine treatment Pregnant women who are more than 16 weeks gestation at enrollment Unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks OR acute treatment within 4 weeks to ensure stability Unwillingness to maintain stable current medication dosages for study duration Failure to complete baseline headache logs Heavy alcohol and illicit drug use Participation in another intervention clinical trial or one that would interfere in this study Experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with MBSR) Any, and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study participant: COVID-positive test within 30 days of enrollment
Sites / Locations
- Cambridge Health Alliance - Center for Mindfulness and Compassion
- Wake Forest University Health Sciences
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Brain Education and WELLness with Migraine Group A
Brain Education and WELLness with Migraine Group B
Arm Description
8 weekly virtual sessions plus online platform
8 weekly virtual sessions plus online platform
Outcomes
Primary Outcome Measures
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
Secondary Outcome Measures
Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks
PHQ-8 has equivalent diagnostic depression accuracy as PHQ-9 and will be used to assess depression. PHQ-8 scores range from 0 to 24. Each of the 9 items can be scored from 0 ("not at all") to 3 ("nearly every day"). Cut-points of 5, 10, 15, and 20 represent the thresholds for mild, moderate, moderately severe, and severe depression, respectively.
Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks
This 13-item scale quantifies an individual's pain experience. Unlike other scales, this does not require for the person to be in pain while completing it. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52.
Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks
A 25-item scale that assesses patient's beliefs in their ability to prevent and/or appropriately manage their headaches and headache-related disability; it has been shown to be valid and reliable. This scale consists of 25 items rated on a 7-point scale that ranges from 1 strongly disagree to 7 strongly agree. Total scores range from 0-175, higher scores reflect more self-efficacy.
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks
Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks
Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks
This is a 7-item scale that quantifies and assess the severity of generalized anxiety disorder, over the past 2 weeks - GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe)
Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks
This is a 14-item questionnaire that measures how migraines affect a patient's daily life and is a highly reliable and valid instrument. The raw scores are transformed to a 0-100 scale and higher scores reflect greater quality of life
Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks
Participants will complete a daily headache log (<10 items) that captures frequency, along with a 7-day recall headache log (<10 items).
Full Information
NCT ID
NCT05987592
First Posted
August 4, 2023
Last Updated
September 28, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT05987592
Brief Title
Be WELL With Migraine: Brain Education and WELLness With Migraine
Official Title
Be WELL With Migraine: Brain Education and WELLness With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.
Detailed Description
This study involves 8 weekly virtual sessions & an online platform designed to improve the lives of patients with migraine. Participants from across the United States with migraine may be eligible to participate. This study does not require any in-person visits. All assessments and surveys will be completed virtually and/or online. Participants will independently complete an initial online screen. Participants will attend a scheduled phone or videoconferencing call with a study team member to complete the baseline assessment and learn how to use the online platform. Participants will keep an online daily headache log and complete several online surveys throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Migraine without aura, Migraine with aura, behavioral, mind-body, integrative, virtual, online
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm parallel assignment in which one group receives treatment A and the other group receives treatment B
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments, will be blinded.
In addition, blinded reports will be provided to the Wake Forest Data and Safety Monitoring Board (DSMB) for safety monitoring.
Allocation
Randomized
Enrollment
286 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brain Education and WELLness with Migraine Group A
Arm Type
Experimental
Arm Description
8 weekly virtual sessions plus online platform
Arm Title
Brain Education and WELLness with Migraine Group B
Arm Type
Experimental
Arm Description
8 weekly virtual sessions plus online platform
Intervention Type
Behavioral
Intervention Name(s)
Brain Education and WELLness with Migraine Group A
Other Intervention Name(s)
Migraine Group A
Intervention Description
Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
Intervention Type
Behavioral
Intervention Name(s)
Brain Education and WELLness with Migraine Group B
Other Intervention Name(s)
Migraine Group B
Intervention Description
Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
Primary Outcome Measure Information:
Title
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
Description
Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
Time Frame
Immediately post-intervention at 8 weeks
Secondary Outcome Measure Information:
Title
Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks
Description
PHQ-8 has equivalent diagnostic depression accuracy as PHQ-9 and will be used to assess depression. PHQ-8 scores range from 0 to 24. Each of the 9 items can be scored from 0 ("not at all") to 3 ("nearly every day"). Cut-points of 5, 10, 15, and 20 represent the thresholds for mild, moderate, moderately severe, and severe depression, respectively.
Time Frame
Immediately post-intervention at 8 weeks
Title
Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks
Description
This 13-item scale quantifies an individual's pain experience. Unlike other scales, this does not require for the person to be in pain while completing it. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52.
Time Frame
Immediately post-intervention at 8 weeks
Title
Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks
Description
A 25-item scale that assesses patient's beliefs in their ability to prevent and/or appropriately manage their headaches and headache-related disability; it has been shown to be valid and reliable. This scale consists of 25 items rated on a 7-point scale that ranges from 1 strongly disagree to 7 strongly agree. Total scores range from 0-175, higher scores reflect more self-efficacy.
Time Frame
Immediately post-intervention at 8 weeks
Title
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks
Description
Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
Time Frame
Post-intervention at 20 weeks
Title
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks
Description
Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
Time Frame
Post-intervention at 32 weeks
Title
Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks
Description
This is a 7-item scale that quantifies and assess the severity of generalized anxiety disorder, over the past 2 weeks - GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe)
Time Frame
Immediately post-intervention at 8 weeks
Title
Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks
Description
This is a 14-item questionnaire that measures how migraines affect a patient's daily life and is a highly reliable and valid instrument. The raw scores are transformed to a 0-100 scale and higher scores reflect greater quality of life
Time Frame
Immediately post-intervention at 8 weeks
Title
Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks
Description
Participants will complete a daily headache log (<10 items) that captures frequency, along with a 7-day recall headache log (<10 items).
Time Frame
Immediately post-intervention at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month
At least 1 year of migraine
At least 18 years old
Able to participate in 8 weekly online classes
Willingness to complete baseline headache logs
Headache-related disability (Headache Impact Test (HIT)-6) score >50
Fluent in English
Completion of technology onboarding with the online platform
Pregnant women who are less than or equal to 16 weeks gestation at enrollment are allowed to participate
Exclusion Criteria:
Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment.
Medication overuse headache, with migraine treatment
Pregnant women who are more than 16 weeks gestation at enrollment
Unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks OR acute treatment within 4 weeks to ensure stability
Unwillingness to maintain stable current medication dosages for study duration
Failure to complete baseline headache logs
Heavy alcohol and illicit drug use
Participation in another intervention clinical trial or one that would interfere in this study
Experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with MBSR)
Any, and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study participant: COVID-positive test within 30 days of enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junelyn Floyd
Phone
336-713-5776
Email
jgfloyd@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Wells, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance - Center for Mindfulness and Compassion
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02141
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Comeau
Email
acomeau@challiance.org
First Name & Middle Initial & Last Name & Degree
Paula Gardner, MD, MPH
First Name & Middle Initial & Last Name & Degree
Zev Schuman-Oliver, MD
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junelyn Floyd
Phone
336-713-5776
Email
jgfloyd@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Rebecca E Wells, MD, MPH
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh A Chamberlin
Email
LeighAnn.Chamberlin@cchmc.org
First Name & Middle Initial & Last Name & Degree
Scott Powers, PhD, ABPP
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data related to our outcome measures will be included in the IPD Sharing Statement (IPD) sharing plan, in addition to our study protocol, informed consent, and analytic plan.
IPD Sharing Time Frame
After publication and within 12 months of completion of the analysis of study primary aims and ending within 36 months, anonymous and de-identified data will be made available on clinicaltrials.gov so that other investigators can verify or follow-up on the reported analyses.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an IRB identified for this purpose - For individual participant data meta-analysis - Data will be made available on clinicaltrials.gov
Learn more about this trial
Be WELL With Migraine: Brain Education and WELLness With Migraine
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