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

Not Applicable

Recruiting

• Conditions: Migraine; Headache; Chronic Migraine; Headache Disorders
• Interventions: Behavioral: Migraine Behavioral Treatment

• Registration Number: NCT06170281
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-14
• Study Start: 2023-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Choice - SE	Migraine Behavioral Treatment	this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise
Choice - ME	Migraine Behavioral Treatment	this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise
Random - MS	Migraine Behavioral Treatment	participants will be randomized to an intervention involving regular mealtime and regular sleep
Choice - MS	Migraine Behavioral Treatment	this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep
Random - ME	Migraine Behavioral Treatment	participants will be randomized to an intervention involving regular mealtime and regular timed exercise
Random - SE	Migraine Behavioral Treatment	participants will be randomized to an intervention involving regular sleep and regular timed exercise

Primary Outcome Measures

Name	Time	Method
Feasibility in terms of recruitment and adherence rates	12 weeks	recruitment rate, adherence rate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States