Brief Interventions in Chronic Migraine

Last updated: February 11, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Migraine (Adult)

Migraine (Pediatric)

Oral Facial Pain

Treatment

Treatment as Usual

Empowered Relief

Health Education (HE)

Clinical Study ID

NCT05979337
HUM00237000
7K23NS125004-02
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Self-reported neurologist diagnosis of chronic migraine

  • Meets diagnostic criteria for chronic migraine according to the Identify ChronicMigraine (IDCM) self-reported instrument

  • English-speaking

  • Internet access and audio-visual conferencing capability (e.g., Zoom meetings byphone or computer) in the home

  • Age 18 years or older

Exclusion

Exclusion Criteria:

  • Currently receiving cognitive-behavioral therapy for pain or migraine

  • Open litigation regarding a medical condition, as assessed in preliminary studyscreening

  • Inability to provide informed consent and complete study procedures (e.g.,indications of suspected major cognitive impairment via observations of study staffduring consenting) that would preclude comprehension or participation in studyprotocols

  • Failure to complete at least 7 out of 14 pre-intervention daily diaries

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Treatment as Usual
Phase:
Study Start date:
October 11, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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