Brief Interventions in Chronic Migraine

University of Michigan

Status: Active, not recruiting

Conditions: Chronic Migraine

Treatments: Behavioral: Empowered Relief; Behavioral: Health Education (HE); Behavioral: Treatment as Usual

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05979337

7K23NS125004-02 (U.S. NIH Grant/Contract)

HUM00237000

Details and patient eligibility

About

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)

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Empowered Relief (ER) class

Experimental group

Description:

Daily Diaries

Treatment:

Behavioral: Empowered Relief

Health Education (HE) class

Experimental group

Treatment:

Behavioral: Health Education (HE)

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

Experimental group

Description:

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

Treatment:

Behavioral: Health Education (HE)

Behavioral: Empowered Relief

Treatment as Usual (TAU)

Other group

Treatment:

Behavioral: Treatment as Usual