Chronic Migraine, Headache, Headache Disorders, Migraine
Conditions
Keywords
migraine, headache, behavioral intervention
Brief summary
This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.
Detailed description
After a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms - * Choice Arm: allowed to choose from a menu of migraine behavioral treatment options * Random: randomized to migraine behavioral treatment options. After 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.
Interventions
BEHAVIORALMigraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Sponsors
Mayo Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* have chronic migraine for a minimum of 1-year * aged 18 years and older
Exclusion criteria
* secondary headache disorders * children younger than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility in terms of recruitment and adherence rates | 12 weeks | recruitment rate, adherence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Frequency | at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization | migraine day frequency |
| Headache Self-efficacy | at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization | headache self-efficacy measured using validated headache self-efficacy questionnaire |
| Migraine Intensity | at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization | migraine intensity, self-reported |
Countries
United States
Contacts
CONTACTYohannes W. Woldeamanuel, MD
PRINCIPAL_INVESTIGATORYohannes W. Woldeamanuel, MD
Mayo Clinic
Outcome results
None listed