Chronic MigraineNCT05979337
Brief Interventions in Chronic Migraine
A study testing Empowered Relief, Health Education (HE) and Treatment as Usual in people with Chronic Migraine, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Empowered Relief, Health Education (HE) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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)
- Conditions
- Chronic Migraine
- Being tested
- Empowered Relief, Health Education (HE), Treatment as Usual
- Keywords
- Health Education, Migraine-related disability, Empowered Relief
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
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)Behavioural
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 UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Empowered Relief (ER) class | Experimental | Daily Diaries Receives: Behavioral: Empowered Relief |
| Health Education (HE) class | Experimental | Not described Receives: Behavioral: Health Education (HE) |
| 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. Receives: Behavioral: Empowered Relief; Behavioral: Health Education (HE) |
| Treatment as Usual (TAU) | Other | Not described Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start11 Oct 2023
- Primary completion4 Mar 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, John Sturgeon, University of Michigan
- Investigators
- John Sturgeon, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979337
- Sponsor's protocol ID
- HUM00237000
- Other IDs
- 7K23NS125004-02
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Behavioral Interventions for Adults With Chronic Migraine
- ClinicalTrials.gov ID
- NCT05979337
- Acronym / sponsor ID
- HUM00237000
- Conditions
- Chronic Migraine
- Keywords
- Health Education, Migraine-related disability, Empowered Relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief (ER) class | Experimental | Behavioral: Empowered ReliefDaily Diaries |
| Health Education (HE) class | Experimental | Behavioral: Health Education (HE) |
| Empowered Relief (ER) class and Health Education (HE) class | Experimental | Behavioral: Empowered Relief, Behavioral: Health Education (HE)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 | Behavioral: Treatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered ReliefThis 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. | Behavioural | Empowered Relief (ER) class, Empowered Relief (ER) class and 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. | Behavioural | Empowered Relief (ER) class and Health Education (HE) class, Health Education (HE) class |
| Treatment as UsualParticipants 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. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Time frame: Baseline, 1 month
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.
11 secondary outcomes
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Time frame: Baseline, 2 months
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Time frame: Baseline, 3 months
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Time frame: Baseline, 6 months
Change Migraine Symptom Severity Scale (MSSS)
Time frame: Baseline, 1 month
Change Migraine Symptom Severity Scale (MSSS)
Time frame: Baseline, 2 month
Change Migraine Symptom Severity Scale (MSSS)
Time frame: Baseline, 3 month
Change Migraine Symptom Severity Scale (MSSS)
Time frame: Baseline, 6 month
Change in Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 1 month
Change in Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 2 month
Change in Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 3 month
Change in Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sturgeon, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief, Health Education (HE) and Treatment as Usual in people with Chronic Migraine, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores (time frame: Baseline, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.