Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-10-11
2027-01-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Empowered Relief (ER) class
Daily Diaries
Empowered Relief
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.
Health Education (HE) class
Health Education (HE)
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.
Empowered Relief (ER) class and Health Education (HE) class
If randomized to both classes, the HE class will occur first with a week break in between to the ER class.
Empowered Relief
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.
Health Education (HE)
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 (TAU)
Treatment as Usual
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.
Interventions
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Empowered Relief
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.
Health Education (HE)
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Age 18 years or older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Michigan
OTHER
Responsible Party
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John Sturgeon
Assistant Professor of Anesthesiology
Principal Investigators
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John Sturgeon, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00237000
Identifier Type: -
Identifier Source: org_study_id
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