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Behavioral Intervention

Behavioral Treatment for Migraines (SMARTMig Trial)

N/A
Recruiting
Led By Yohannes W Woldeamanuel, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
have chronic migraine for a minimum of 1-year
aged 18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand and improve a behavioral intervention for migraines. It will also investigate the best combinations of treatments and how people's preferences and choices can affect the trial outcomes.

Who is the study for?
This trial is for adults who have been experiencing chronic migraines for at least one year. It's designed to find the best combination of behavioral treatments.
What is being tested?
The study explores various behavioral interventions for managing migraines, examining which combinations work best and how personal preferences affect outcomes.
What are the potential side effects?
Since this trial focuses on behavioral treatments, there may be minimal to no physical side effects; however, participants might experience temporary increases in headache or stress during adjustment periods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had chronic migraines for at least 1 year.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility in terms of recruitment and adherence rates
Secondary study objectives
Headache Self-efficacy
Migraine Frequency
Migraine Intensity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Active Control
Group I: Choice - MEActive Control1 Intervention
this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise
Group II: Random - MEActive Control1 Intervention
participants will be randomized to an intervention involving regular mealtime and regular timed exercise
Group III: Random - MSActive Control1 Intervention
participants will be randomized to an intervention involving regular mealtime and regular sleep
Group IV: Random - SEActive Control1 Intervention
participants will be randomized to an intervention involving regular sleep and regular timed exercise
Group V: Choice - MSActive Control1 Intervention
this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep
Group VI: Choice - SEActive Control1 Intervention
this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
652,168 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,916 Total Patients Enrolled
Yohannes W Woldeamanuel, MDPrincipal InvestigatorStanford University
~9 spots leftby Jul 2025
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