Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial (SMARTMig)

Stanford University

Status: Enrolling

Conditions: Headache Disorders; Chronic Migraine; Migraine; Headache

Treatments: Behavioral: Migraine Behavioral Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06170281

K01NS124911 (U.S. NIH Grant/Contract)

70767

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Random - ME

Active Comparator group

Description:

participants will be randomized to an intervention involving regular mealtime and regular timed exercise

Treatment:

Behavioral: Migraine Behavioral Treatment

Random - MS

Active Comparator group

Description:

participants will be randomized to an intervention involving regular mealtime and regular sleep

Treatment:

Behavioral: Migraine Behavioral Treatment

Random - SE

Active Comparator group

Description:

participants will be randomized to an intervention involving regular sleep and regular timed exercise

Treatment:

Behavioral: Migraine Behavioral Treatment

Choice - ME

Active Comparator group

Description:

this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise

Treatment:

Behavioral: Migraine Behavioral Treatment

Choice - MS

Active Comparator group

Description:

this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep

Treatment:

Behavioral: Migraine Behavioral Treatment

Choice - SE

Active Comparator group

Description:

this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise

Treatment:

Behavioral: Migraine Behavioral Treatment