Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention

Conditions
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Migraine, Headache, Chronic Migraine, Headache Disorders

Intervention / Treatment
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* Behavioral: Migraine Behavioral Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Random - ME<br>participants will be randomized to an intervention involving regular mealtime and regular timed exercise | Behavioral: Migraine Behavioral Treatment<br>* Migraine Behavioral Treatment involving daily activities<br>|
| Active Comparator: Random - MS<br>participants will be randomized to an intervention involving regular mealtime and regular sleep | Behavioral: Migraine Behavioral Treatment<br>* Migraine Behavioral Treatment involving daily activities<br>|
| Active Comparator: Random - SE<br>participants will be randomized to an intervention involving regular sleep and regular timed exercise | Behavioral: Migraine Behavioral Treatment<br>* Migraine Behavioral Treatment involving daily activities<br>|
| Active Comparator: Choice - ME<br>this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise | Behavioral: Migraine Behavioral Treatment<br>* Migraine Behavioral Treatment involving daily activities<br>|
| Active Comparator: Choice - MS<br>this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep | Behavioral: Migraine Behavioral Treatment<br>* Migraine Behavioral Treatment involving daily activities<br>|
| Active Comparator: Choice - SE<br>this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise | Behavioral: Migraine Behavioral Treatment<br>* Migraine Behavioral Treatment involving daily activities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility in terms of recruitment and adherence rates | recruitment rate, adherence rate | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine Frequency | migraine day frequency | at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization | 
| Headache Self-efficacy | headache self-efficacy measured using validated headache self-efficacy questionnaire | at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization | 
| Migraine Intensity | migraine intensity, self-reported | at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, headache, behavioral intervention