NCT05979337

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)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Oct 2023Jan 2027

First Submitted

Initial submission to the registry

July 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

July 28, 2023

Last Update Submit

May 6, 2026

Conditions

Chronic Migraine

Keywords

Health EducationMigraine-related disabilityEmpowered Relief

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores

    Baseline, 2 months

  • Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores

    Baseline, 3 months

  • Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores

    Baseline, 6 months

  • Change Migraine Symptom Severity Scale (MSSS)

    Baseline, 1 month

  • Change Migraine Symptom Severity Scale (MSSS)

    Baseline, 2 month

  • +6 more secondary outcomes

Study Arms (4)

Empowered Relief (ER) class

EXPERIMENTAL

Daily Diaries

Behavioral: Empowered Relief

Health Education (HE) class

EXPERIMENTAL
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.

Behavioral: Empowered ReliefBehavioral: Health Education (HE)

Treatment as Usual (TAU)

OTHER
Behavioral: Treatment as Usual

Interventions

Empowered ReliefBEHAVIORAL

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.

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

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) classHealth Education (HE) class
Treatment as UsualBEHAVIORAL

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.

Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Health Education

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • John Sturgeon, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 7, 2023

Study Start

October 11, 2023

Primary Completion (Estimated)

September 2, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.
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.

Locations

US(1)