BE WELL With Migraine: Brain Education and WELLness With Migraine

Migraine Clinical Trial

Official title:

BE WELL With Migraine: Brain Education and WELLness With Migraine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05987592
• Other study ID #: IRB00079570
• Secondary ID: R01AT011502
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: July 2023
• Source: Wake Forest University Health Sciences
• Contact: Junelyn Floyd
• Phone: 336-713-5776
• Email: jgfloyd[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 286
• Est. completion date: June 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• Brain Education and WELLness with Migraine Group A
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
• Brain Education and WELLness with Migraine Group B
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

Locations

Country	Name	City	State
United States	Cambridge Health Alliance - Center for Mindfulness and Compassion	Cambridge	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately post-intervention at 8 weeks
Secondary	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.	Immediately post-intervention at 8 weeks
Secondary	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.	Immediately post-intervention at 8 weeks
Secondary	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.	Immediately post-intervention at 8 weeks
Secondary	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.	Post-intervention at 20 weeks
Secondary	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.	Post-intervention at 32 weeks
Secondary	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)	Immediately post-intervention at 8 weeks
Secondary	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	Immediately post-intervention at 8 weeks
Secondary	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).	Immediately post-intervention at 8 weeks