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Brief Interventions in Chronic Migraine

Primary Purpose

Chronic Migraine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empowered Relief
Health Education (HE)
Treatment as Usual
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring Health Education, Migraine-related disability, Empowered Relief

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Empowered Relief (ER) class

Health Education (HE) class

Empowered Relief (ER) class and Health Education (HE) class

Treatment as Usual (TAU)

Arm Description

Daily Diaries

If randomized to both classes, the HE class will occur first with a week break in between to the ER class.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 28, 2023
Last Updated
October 18, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05979337
Brief Title
Brief Interventions in Chronic Migraine
Official Title
Brief Behavioral Interventions for Adults With Chronic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2023 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
Health Education, Migraine-related disability, Empowered Relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empowered Relief (ER) class
Arm Type
Experimental
Arm Description
Daily Diaries
Arm Title
Health Education (HE) class
Arm Type
Experimental
Arm Title
Empowered Relief (ER) class and Health Education (HE) class
Arm Type
Experimental
Arm Description
If randomized to both classes, the HE class will occur first with a week break in between to the ER class.
Arm Title
Treatment as Usual (TAU)
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Empowered Relief
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education (HE)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Description
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.
Time Frame
Baseline, 1 month
Secondary Outcome Measure Information:
Title
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Description
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.
Time Frame
Baseline, 2 months
Title
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Description
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.
Time Frame
Baseline, 3 months
Title
Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
Description
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.
Time Frame
Baseline, 6 months
Title
Change Migraine Symptom Severity Scale (MSSS)
Description
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.
Time Frame
Baseline, 1 month
Title
Change Migraine Symptom Severity Scale (MSSS)
Description
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.
Time Frame
Baseline, 2 month
Title
Change Migraine Symptom Severity Scale (MSSS)
Description
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.
Time Frame
Baseline, 3 month
Title
Change Migraine Symptom Severity Scale (MSSS)
Description
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.
Time Frame
Baseline, 6 month
Title
Change in Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline, 1 month
Title
Change in Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline, 2 month
Title
Change in Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline, 3 month
Title
Change in Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Baseline, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Fauser
Phone
734-998-7034
Email
fausera@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sturgeon, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Fauser
Phone
734-998-7034
Email
fausera@umich.edu
First Name & Middle Initial & Last Name & Degree
John Sturgeon, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Brief Interventions in Chronic Migraine

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