Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 7K23NS125004-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
People with chronic migraine headaches face many challenges, including high levels of daily pain, disturbances to everyday activities and sleep, and problems with mood such as depression or anxiety. This trial is being completed to study whether changing an individual's behaviors may have an impact as a treatment for migraine headaches.
Eligible participants will be randomized to one of the four arms. This study will be conducted remotely without in-person contact.
Study Hypothesis:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowered Relief (ER) class | Experimental | Daily Diaries |
|
| Health Education (HE) class | Experimental |
| |
| Empowered Relief (ER) class and Health Education (HE) class | Experimental | If randomized to both classes, the HE class will occur first with a week break in between to the ER class. |
|
| Treatment as Usual (TAU) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowered Relief | Behavioral | This is a single-session (2-hour) behavioral intervention utilizing pain psychology principles (cognitive-behavioral therapy for pain, pain neuroscience education). Class will take place over zoom and have up to 25 participants. The Zoom classes will not be recorded. Participant will be asked to have the camera on during the entire class for treatment course/class validity. Participants are not required to speak during the class but are welcome to ask questions. Participants will complete daily diaries for 14 days prior to attending study classes, and another 14 days after completing study classes. In addition, participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores | The MIDAS is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability. | Baseline, 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores | The MIDAS-28 is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability. | Baseline, 2 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Sturgeon, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
De-identified datasets including participant self-report data (baseline, follow-up and daily diary-based assessments) will be maintained and made available to external researchers upon request via the Inter-University Consortium for Political and Social Research (ICPSR) data repository at University of Michigan.
De-identified datasets will be made available after publication of the primary study results and/or at the conclusion of the National Institute of Neurological Disorders and Stroke (NINDS)-funded grant study period (currently December 2026, barring any no-cost extension. Data will remain available for at least 3 years beyond the end date of the study.
Data may be shared with other investigators interested in learning more about the nature of behavioral interventions for individuals with chronic migraine. All datasets will be de-identified and shared only after interested researchers contact ICPSR and complete a restricted data use agreement.
The data and associated documentation will be made available to users only under a restricted data-sharing agreement through ICPSR that provides for (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; and (c) a commitment to destroying or returning the data after analyses are completed. Such a data-use agreement will be executed through the PI and ICPSR through the University of Michigan.
Not provided
Not provided
| ID | Term |
|---|---|
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Health Education (HE) | Behavioral | This is a single-session (2-hour) health education class reviewing principles of medically indicated self-management of migraine headaches (e.g., consistent dietary and hydration habits, exercise, understanding of and adherence to medical treatment regimens). Class will take place over zoom and have up to 25 participants. The Zoom classes will not be recorded. Participant will be asked to have the camera on during the entire class for treatment course/class validity. Participants are not required to speak during the class but are welcome to ask questions. Participants will complete daily diaries for 14 days prior to attending study classes, and another 14 days after completing study classes. In addition, participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life. |
|
| Treatment as Usual | Behavioral | Participants will complete questionnaires and information about medical and personal history, symptoms, mood, sleep, medication use, and ability to function in daily life. In addition, participants will complete daily diaries for 28 days. If participants are interested in attending classes that were not part of this group assignment, participants will be invited to do so after completing the 6-month follow-up questionnaire. |
|
| Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores | The MIDAS-28 is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability. | Baseline, 3 months |
| Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores | The MIDAS-28 is a 5-item questionnaire to measure the impact of headaches on life. Subjects indicate how many days headaches have impacted a specific activity. Score ranges: 0-5: little or no disability; 6-10: mild disability; 11-20: moderate disability: 21 (+) severe disability. | Baseline, 6 months |
| Change Migraine Symptom Severity Scale (MSSS) | A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed. | Baseline, 1 month |
| Change Migraine Symptom Severity Scale (MSSS) | A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed. | Baseline, 2 month |
| Change Migraine Symptom Severity Scale (MSSS) | A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed. | Baseline, 3 month |
| Change Migraine Symptom Severity Scale (MSSS) | A composite score of 7 self-report questions that incorporates information about headache criteria (unilateral pain, pulsatile pain, moderate, or severe pain intensity, routine activities worsen pain, nausea, photophobia, and phonophobia). The overall MSSS score ranges from 0 to 21 calculated by adding scores ranging from 0 to 3 for each of the 7 headache features assessed. | Baseline, 6 month |
| Change in Pain Catastrophizing Scale (PCS) | The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse. | Baseline, 1 month |
| Change in Pain Catastrophizing Scale (PCS) | The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse. | Baseline, 2 month |
| Change in Pain Catastrophizing Scale (PCS) | The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse. | Baseline, 3 month |
| Change in Pain Catastrophizing Scale (PCS) | The PCS has 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse. | Baseline, 6 month |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |