Brief Interventions in Chronic Migraine

Study Overview
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Brief Summary
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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: There is a main effect of attending either the Empowered Relief and Health Education intervention on reductions in migraine-related disability 1 month after completing either intervention There is a main effect of Empowered Relief and Health Education interventions on reducing pain-related catastrophizing and migraine symptom severity 1 month after completing either intervention (secondary hypothesis) The expected reductions in migraine-related disability, pain catastrophizing, and migraine symptom severity will be maintained at secondary time points (2 months, 3 months, and 6 months after completing either intervention) (secondary hypothesis)

Official Title
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Brief Behavioral Interventions for Adults With Chronic Migraine

Conditions
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Chronic Migraine

Intervention / Treatment
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* Behavioral: Empowered Relief
* Behavioral: Health Education (HE)
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported neurologist diagnosis of chronic migraine Meets diagnostic criteria for chronic migraine according to the Identify Chronic Migraine (IDCM) self-reported instrument English-speaking Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home Exclusion Criteria: Currently receiving cognitive-behavioral therapy for pain or migraine Open litigation regarding a medical condition, as assessed in preliminary study screening Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols Failure to complete at least 7 out of 14 pre-intervention daily diaries

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empowered Relief (ER) class<br>Daily Diaries | Behavioral: Empowered Relief<br>* 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.<br>|
| Experimental: Health Education (HE) class<br> | Behavioral: Health Education (HE)<br>* 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.<br>|
| Experimental: Empowered Relief (ER) class and Health Education (HE) class<br>If randomized to both classes, the HE class will occur first with a week break in between to the ER class. | Behavioral: Empowered Relief<br>* 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.<br>Behavioral: Health Education (HE)<br>* 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.<br>|
| Other: Treatment as Usual (TAU)<br> | Behavioral: Treatment as Usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Education, Migraine-related disability, Empowered Relief