Online Intervention for Migraines

Overseen By Kevin Hommel, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Pervasive developmental disorder, serious mental illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online tool called Migraine Manager to determine its effectiveness in reducing headaches in adolescents with migraines. It compares Migraine Manager to a basic online activity to identify which is more effective. Participants use Migraine Manager to track healthy habits such as hydration, meals, exercise, and sleep. Children aged 11 to 17 with migraines, experiencing eight or more headaches a month, and having internet access may be eligible to join. The goal is to discover if maintaining good habits can reduce headache days and improve quality of life. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on an online intervention for managing migraines.

What prior data suggests that the Migraine Manager intervention is safe for adolescents with migraines?

Research has shown that the Migraine Manager treatment has undergone testing in previous studies. One study found that participants using Migraine Manager reduced their headache days from 17 to just 8 after two months. This suggests the treatment is effective and easy to use.

No reports of serious side effects have emerged from using Migraine Manager. As an online program promoting healthy habits like adequate hydration and good sleep, the risks appear low. The trial is in an early stage, so researchers are closely monitoring safety. However, evidence so far suggests it is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Migraine Manager because it offers a highly personalized approach to managing migraines. Unlike traditional treatments that often involve medication like triptans or preventive drugs, Migraine Manager is an online portal with 16 customizable modules. These modules are tailored to each participant based on their specific needs and daily assessments, allowing for a more individualized treatment experience. By integrating these personalized modules with daily diaries, it aims to provide actionable insights and guidance for both patients and their parents, potentially improving migraine management outcomes without the side effects associated with medications.

What evidence suggests that the Migraine Manager could be an effective treatment for migraines?

Research has shown that the Migraine Manager, which participants in this trial may receive, can reduce the number of headache days for teenagers with migraines. In earlier studies, individuals using the Migraine Manager experienced fewer headache days over an 8-week period. This online tool provides personalized tips on healthy habits such as staying hydrated, eating well, exercising, and getting good sleep, all of which can alleviate headaches. Participants also maintained daily diaries to track their progress, and the results were promising for managing migraines. The focus on personalized advice based on individual needs helps individuals adhere to these healthy habits, potentially improving migraine management overall. ^{1 4 6 7 8}

Who Is on the Research Team?

Susan LeCates, MSN, FNP

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Scott Powers, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Marielle Kabbouche-Samaha, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Kevin Hommel, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Andrew Hershey, MD, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Lee Ritterband, MD

Principal Investigator

University of Virginia

James Peugh, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Access to the internet whether public (e.g., library) or private (e.g., home, personal)

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

English fluency for patient and caregiver

Exclusion Criteria

You have a serious mental illness, like a psychotic disorder, as confirmed by your medical records.

You have been diagnosed with a pervasive developmental disorder according to your medical records.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Migraine Manager intervention or attention control intervention for eight weeks

8 weeks

Online daily diaries

Follow-up

Participants are monitored for headache outcomes and secondary measures at 3, 6, 9, and 12 months post-intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Migraine Manager

Trial Overview 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.

How Is the Trial Designed?

Group I: Migraine Manager Experimental Treatment 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

The web-based intervention significantly improved participants' self-efficacy in managing headaches and encouraged the use of positive strategies like relaxation and social support, based on assessments from 6 months involving both an experimental and a control group.

Participants in the intervention group reported lower levels of pain catastrophizing, depression, and stress, indicating that this behavioral approach could effectively complement medical treatments for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a web-based intervention to improve migraine self-management and coping. Bromberg, J., Wood, ME., Black, RA., et al.[2022]

A telephone-administered behavioral migraine management program (TAT) was well-received by adolescents, with 93% reporting a positive relationship with their phone counselor and a preference for this method over in-clinic visits.

Participants in the TAT group showed significant improvements in migraine frequency (54% and 71% reduction), disability, and quality of life, indicating that TAT may be an effective and accessible treatment option for adolescents with migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility assessment of telephone-administered behavioral treatment for adolescent migraine. Cottrell, C., Drew, J., Gibson, J., et al.[2021]

The MyMigraine Internet training aid for migraine self-management received positive feedback from both new patients (n=10) and expert patients (n=6), indicating it is clear, instructive, and user-friendly, with average ratings around 3.5 to 4.1 on various aspects.

Both groups found the training aid beneficial for detecting attack risks and developing preventive coping strategies, although expert patients highlighted the importance of maintaining patient-to-patient contact for additional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User acceptance of an Internet training aid for migraine self-management. Sorbi, MJ., van der Vaart, R.[2019]

The study involving 44 migraine patients demonstrated that online digital assistance (ODA) is feasible and well-accepted as a supportive tool for behavioral training (BT), with minimal technical issues and positive participant feedback.

However, the addition of ODA did not lead to significantly better outcomes in terms of migraine attack frequency or quality of life compared to those who only received BT, indicating that while ODA is useful, its effectiveness in enhancing BT results remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and preliminary effects of online digital assistance (ODA) for behavioral attack prevention in migraine. Kleiboer, A., Sorbi, M., Mérelle, S., et al.[2015]

The online behavioral training (oBT) for migraine self-management significantly improved self-efficacy and quality of life for participants, indicating its effectiveness in empowering individuals to manage their migraines better.

While both the oBT group and the waitlist control group experienced a reduction in migraine attack frequency, the oBT group showed unique benefits in self-management skills and quality of life, suggesting that the training may foster active engagement in managing migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term effectiveness of online behavioral training in migraine self-management: A randomized trial controlled over 10 months. Sorbi, MJ., Kleiboer, AM., van Silfhout, HG., et al.[2015]

A pilot study involving 139 adults with migraines found that a smartphone app delivering progressive muscle relaxation (PMR) was well-accepted, with participants rating its usability and willingness to engage in the intervention positively.

While the PMR group showed a greater decline in migraine-related disability scores compared to the control group, the results were not statistically significant, indicating potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial. Minen, MT., Adhikari, S., Padikkala, J., et al.[2022]

Online behavioral training (oBT) significantly reduced the frequency of migraine attacks by an average of 23% over 20 months in participants with frequent episodic migraines, especially benefiting those with higher baseline attack rates.

The positive effects of oBT were durable, lasting for up to 16 months after training, indicating that this self-management approach is an effective and sustainable option for migraine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up over 20 months confirms gains of online behavioural training in frequent episodic migraine. Sorbi, MJ., Balk, Y., Kleiboer, AM., et al.[2017]

Refractory migraine (RM) and refractory chronic migraine (R-CM) are defined by five key components, including significant functional interference from headaches despite adequate treatment across various domains, which is crucial for future epidemiologic research.

Two important modifiers for RM and R-CM have been identified: medication overuse and a high disability score (11 or greater on the Migraine Disability Assessment), which can further influence the understanding and management of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward an epidemiology of refractory migraine: current knowledge and issues for future research. Lipton, RB., Bigal, ME.[2009]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04567355?cond=%22Migraine%22&rank=7

Study Details | NCT04567355 | Migraine Manager (R01) 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 ...

2. ctv.veeva.com ctv.veeva.com/study/migraine-manager-r01

Migraine Manager (R01) - ClinicalTrials.Veeva The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04567355/migraine-manager-r01

Migraine Manager (R01) | Clinical Research Trial Listing The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes ...

4. withpower.com withpower.com/trial/phase-migraine-disorders-4-2021-a1a6a

Online Intervention for Migraines The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7263949/

Feasibility and Preliminary Efficacy of “Migraine Manager” Headache days during the 8-week intervention were reported via daily headache diaries completed online. There was a statistically significant decrease in ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04567355?keyword=%22Migraine%22

San Mateo Clinical Trial Migraine Manager (R01) The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to ...

7. goodday.health goodday.health/trials/4567355

MM R01 - GoodDay The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an

8. policylab.us policylab.us/clinical-trials/l/conditions/migraine?page=2

Migraine Clinical Trials - Policy Lab This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine.