Clinical trial NCT05979337: Brief Interventions in Chronic Migraine
Official title: Brief Behavioral Interventions for Adults With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine
Keywords: Health Education
Migraine-related disability
Empowered Relief
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-08-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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)


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
* 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

Primary outcomes:
measure: Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
timeFrame: Baseline, 1 month
Secondary outcomes:
measure: Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
timeFrame: Baseline, 2 months
measure: Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
timeFrame: Baseline, 3 months
measure: Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores
timeFrame: Baseline, 6 months
measure: Change Migraine Symptom Severity Scale (MSSS)
timeFrame: Baseline, 1 month
measure: Change Migraine Symptom Severity Scale (MSSS)
timeFrame: Baseline, 2 month
measure: Change Migraine Symptom Severity Scale (MSSS)
timeFrame: Baseline, 3 month
measure: Change Migraine Symptom Severity Scale (MSSS)
timeFrame: Baseline, 6 month
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 1 month
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 2 month
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 3 month
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 6 month
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: John Sturgeon, PhD
role: PRINCIPAL_INVESTIGATOR
References: