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

January 26, 2024 updated by: Dr. Yohannes Woldeamanuel, MD, Stanford University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Random - ME
participants will be randomized to an intervention involving regular mealtime and regular timed exercise
Behavioral: Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Active Comparator: Random - MS
participants will be randomized to an intervention involving regular mealtime and regular sleep
Behavioral: Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Active Comparator: Random - SE
participants will be randomized to an intervention involving regular sleep and regular timed exercise
Behavioral: Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Active Comparator: Choice - ME
this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise
Behavioral: Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Active Comparator: Choice - MS
this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep
Behavioral: Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Active Comparator: Choice - SE
this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise
Behavioral: Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility in terms of recruitment and adherence rates
Time Frame: 12 weeks
recruitment rate, adherence rate
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine Frequency
Time Frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
migraine day frequency
at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Headache Self-efficacy
Time Frame: 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
at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Migraine Intensity
Time Frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
migraine intensity, self-reported
at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Yohannes W Woldeamanuel, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70767
  • K01NS124911 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication, for 2 years

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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