Brief Interventions in Chronic Migraine

Brief Behavioral Interventions for Adults With Chronic Migraine

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Migraine
• Intervention / Treatment: Behavioral: Empowered Relief; Behavioral: Health Education (HE); Behavioral: Treatment as Usual

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Age 18 years or older

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment as Usual (TAU)	Behavioral: 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.
Experimental: Empowered Relief (ER) class; Daily Diaries	Behavioral: 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.
Experimental: Health Education (HE) class	Behavioral: 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.
Experimental: 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.	Behavioral: 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.; Behavioral: 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.

What is the study measuring?

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 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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: John Sturgeon, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Health Education; Migraine-related disability; Empowered Relief
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Health Education; Therapeutics
• Other Study ID Numbers: HUM00237000; 7K23NS125004-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.

IPD Sharing Access Criteria

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.

• 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
• product manufactured in and exported from the U.S.: No