BE WELL With Migraine: Brain Education and WELLness With Migraine

April 23, 2024 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02141
        • Cambridge Health Alliance - Center for Mindfulness and Compassion
        • Contact:
        • Sub-Investigator:
          • Paula Gardner, MD, MPH
        • Sub-Investigator:
          • Zev Schuman-Oliver, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Rebecca E Wells, MD, MPH
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Scott Powers, PhD, ABPP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain Education and WELLness with Migraine Group A
8 weekly virtual sessions plus online platform
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
Other Names:
  • Migraine Group A
Experimental: Brain Education and WELLness with Migraine Group B
8 weekly virtual sessions plus online platform
Behavioral: 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
Other Names:
  • Migraine Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
Time Frame: Immediately post-intervention at 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks
Time Frame: Immediately post-intervention at 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
Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks
Time Frame: Immediately post-intervention at 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
Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks
Time Frame: Immediately post-intervention at 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
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks
Time Frame: Post-intervention at 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
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks
Time Frame: Post-intervention at 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
Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks
Time Frame: Immediately post-intervention at 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
Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks
Time Frame: Immediately post-intervention 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
Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks
Time Frame: Immediately post-intervention at 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Rebecca E Wells, MD, MPH, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00079570
  • R01AT011502 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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