Brief Interventions in Chronic Migraine

Chronic Migraine Clinical Trial

Official title:

Brief Behavioral Interventions for Adults With Chronic Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979337
• Other study ID #: HUM00237000
• Secondary ID: 7K23NS125004-02
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: January 2027

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Courtni Minghine-Beemer
• Phone: 734-998-0040
• Email: mcourtni[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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