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Online Intervention for Migraines

Phase 2

Recruiting

Led By Kevin Hommel, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an online intervention can help improve headache outcomes for adolescents with migraines, compared to an attention control intervention. The primary outcome will be the number of headache days, assessed via online daily diary pre- and post-intervention.

Who is the study for?

This trial is for young people aged 11 to 17 who have migraines, with at least 8 headache days per month. They must be diagnosed according to the International Classification of Headache Disorders and need internet access. Those with developmental disorders or serious mental illnesses are not eligible.

What is being tested?

The Migraine Manager clinical trial tests an online program designed to help adolescents manage their migraines by promoting healthy habits like staying hydrated, eating regularly, exercising, and getting enough sleep against a control group.

What are the potential side effects?

Since the intervention is non-medical and focuses on lifestyle management through an online platform, there are no direct medical side effects associated with it. However, individual experiences may vary based on adherence and personal health changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with migraine, with or without aura.

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I experience 8 or more headaches a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Headache frequency

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Migraine ManagerExperimental Treatment1 Intervention

The Migraine Manager portal intervention is comprised of 16 modules that are assigned in an individually tailored manner to participants based on their answers to a brief assessment battery. Once assessments are completed, a treatment plan consisting of recommended modules is automatically generated for patient and parent guidance, and the user is directed to the list of recommended modules. Participants will also complete online daily diaries for eight weeks.

Group II: Attention ControlActive Control1 Intervention

Participants in this arm will complete the online daily diaries for eight weeks (i.e., equal time as the Migraine Manager arm) through the portal but will be restricted from receiving intervention content; they will also receive equal number of communications via the portal as the Migraine Manager arm. Data from migraine daily diaries will not be available to AC participants or their clinicians as this would likely be used clinically and lead to contamination of the control arm resulting from varying levels of intervention across participants based on their data.

0 / 2Eligibility criteria met