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

NCT06170281 | Not Yet Recruiting

• 2 other identifiers: 24-006447K01NS124911
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Headache; Chronic Migraine; Headache Disorders

Keywords

migraine; headache; behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Feasibility in terms of recruitment and adherence rates

  recruitment rate, adherence rate

  12 weeks

Secondary Outcomes (3)

• Migraine Frequency

  at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization

• Headache Self-efficacy

  at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization

• Migraine Intensity

  at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization

Study Arms (6)

Random - ME

ACTIVE COMPARATOR

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

Behavioral: Migraine Behavioral Treatment

Random - MS

ACTIVE COMPARATOR

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

Behavioral: Migraine Behavioral Treatment

Random - SE

ACTIVE COMPARATOR

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

Behavioral: Migraine Behavioral Treatment

Choice - ME

ACTIVE COMPARATOR

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

Behavioral: Migraine Behavioral Treatment

Choice - MS

ACTIVE COMPARATOR

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

Behavioral: Migraine Behavioral Treatment

Choice - SE

ACTIVE COMPARATOR

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

Behavioral: Migraine Behavioral Treatment

Interventions

Migraine Behavioral Treatment BEHAVIORAL

Migraine Behavioral Treatment involving daily activities

Choice - ME; Choice - MS; Choice - SE; Random - ME; Random - MS; Random - SE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have chronic migraine for a minimum of 1-year
• aged 18 years and older

You may not qualify if:

• secondary headache disorders
• children younger than 18 years old

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Related Publications (3)

• Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038/s41598-020-59738-1.

  PMID: 32071349 BACKGROUND

• Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007/s00415-016-8031-5. Epub 2016 Jan 25.

  PMID: 26810728 BACKGROUND

• Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6.

  PMID: 34357593 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache; Headache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yohannes W. Woldeamanuel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yohannes W. Woldeamanuel, MD

CONTACT

480-342-1385; Woldeamanuel.YohannesWoubishet@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: December 14, 2023
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication, for 2 years
• 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).

Locations

US (1)