NCT06170281

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Headache
• Chronic Migraine
• Headache Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Migraine Behavioral Treatment	Migraine Behavioral Treatment involving daily activities

Timeline

• Start date: 2023-12-15
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2023-12-14
• Last updated: 2024-01-29

Locations

1 site across 1 country: United States