Brief Interventions in Chronic Migraine
- Conditions
- Chronic Migraine
- Interventions
- Behavioral: Empowered ReliefBehavioral: Treatment as UsualBehavioral: Health Education (HE)
- Registration Number
- NCT05979337
- Lead Sponsor
- University of Michigan
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Empowered Relief (ER) class and Health Education (HE) class Empowered Relief If randomized to both classes, the HE class will occur first with a week break in between to the ER class. Treatment as Usual (TAU) Treatment as Usual - Empowered Relief (ER) class Empowered Relief Daily Diaries Health Education (HE) class Health Education (HE) - Empowered Relief (ER) class and Health Education (HE) class Health Education (HE) If randomized to both classes, the HE class will occur first with a week break in between to the ER class.
- Primary Outcome Measures
Name Time Method Change in Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores Baseline, 1 month 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
Name Time Method Change in Pain Catastrophizing Scale (PCS) Baseline, 6 month 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 Migraine Disability Assessment Test - 28 Day Version (MIDAS-28) Scores Baseline, 6 months 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) Baseline, 6 month 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.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States