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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT011502 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Education and WELLness with Migraine Group A | Experimental | 8 weekly virtual sessions plus online platform |
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| Brain Education and WELLness with Migraine Group B | Experimental | 8 weekly virtual sessions plus online platform |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Education and WELLness with Migraine Group A | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Tamol | Contact | 336-978-1362 | Help4Migraine@wfusm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca E Wells, MD, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge Health Alliance - Center for Mindfulness and Compassion | Not yet recruiting | Cambridge | Massachusetts | 02141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41065019 | Derived | Wells RE, Floyd J, O'Brien H, Tamol N, Oliver C, Nelson C, Phillips J, Estave PM, Vaidya S, Moore B, Hamilton K, Adam E, O'Connell N, Moore JB, Lipton RB, Houle TT, Schuman-Olivier Z, Gardiner P, Powers SW; BE WELL with Migraine Champion Providers Network. Building a national headache medicine research network: The BE WELL with Migraine Champion Providers Network. Headache. 2026 Jan;66(1):249-261. doi: 10.1111/head.15065. Epub 2025 Oct 9. |
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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.
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.
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
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020326 | Migraine without Aura |
| D020325 | Migraine with Aura |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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Two-arm parallel assignment in which one group receives treatment A and the other group receives treatment B
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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.
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| Brain Education and WELLness with Migraine Group B | Behavioral | 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 |
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| Immediately post-intervention at 8 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Cincinnati Children's Hospital Medical Center | Not yet recruiting | Cincinnati | Ohio | 45229-3039 | United States |
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| D009422 | Nervous System Diseases |