Migraine Manager (R01)

Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04567355

Enrollment

160

Registered

2020-09-28

Start date

2021-06-10

Completion date

2026-06-30

Last updated

2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine, Migraine Disorders

Keywords

Migraine

Brief summary

The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.

Interventions

BEHAVIORALMigraine Manager

Answers provided during the online assessment will result in certain intervention recommendations. Once assessments are completed, a treatment plan will be automatically generated for patient and parent guidance.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments will be blinded. Only one team member (lead CRC) will have access to the assignment of each participant.

Eligibility

Sex/Gender

ALL

Age

11 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura * Frequency of 8 or more headaches per month * Access to the internet whether public (e.g., library) or private (e.g., home, personal) * English fluency for patient and caregiver

Exclusion criteria

* Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review * Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review

Design outcomes

Primary

Measure	Time frame	Description
Headache frequency	15 months	Change in number of days with a headache