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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details
    Migraine
    Headache
    Chronic Migraine
    Headache Disorders

NCT06170281

Stanford University

17 February 2024

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