Mind Body Balance for Pediatric Migraine

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Migraine With Aura; Headache Disorders; Migraine Disorders; Chronic Migraine; Migraine Without Aura; Migraine; Headache, Migraine; Headache

Treatments: Behavioral: 40 minute session; Behavioral: home practice e-health; Behavioral: home practice handout; Behavioral: 20 minute session; Behavioral: phone call

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04715685

U01AT010132 (U.S. NIH Grant/Contract)

MOST Study

Details and patient eligibility

About

This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.

Full description

In the United States, over 6 million children and adolescents suffer from migraine headaches and it is 1 of the 5 most prevalent childhood disorders. Mind and body approaches can significantly help these youth, but getting access to this type of treatment is a challenge for families. Our mind and body study will test a mind and body intervention package delivered by health care professionals (i.e., nurses) introducing coping skills to youth ages 10 to 17 that have migraine.

Using a factorial design and the multiphase optimization strategy "MOST", in this study we are able to evaluate different doses of 3 treatment components (1. Duration of mind and body skill introduction session; 2. Home practice support intensity; and 3. Adherence prompt phone call) in one project. A screening experiment will be conducted to determine the dose of each treatment component for future evaluation of the optimized intervention package in a pragmatic or SMART trial.

Enrollment: 260 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders(ICHD) criteria
• Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 4 and ≤ 28.
• PedMIDAS: PedMIDAS Disability Score > 4, indicating at least mild disruption in daily activities and < 140, indicating extreme disability that may require more comprehensive, multi-component therapy
• Use of one or more of the following prescribed nutraceuticals and/or preventive anti-migraine medications at the time or randomization or be on a stable dose of one or more of the following throughout the 12 weeks of the study [Vitamin B2 (Riboflavin), Co-Q 10 (Coenzyme Q10), Magnesium (Mg), Vitamin D2 or D3 (Erocalciferol/Cholecalciferol), Depakote (Divalproate), Inderal (Propanerol), Elavil ((Amitripyline), Topamax (Topiramate), Periactin (Cyproheptadine)]
• Language: English speaking, able to complete interviews and questionnaires in English

Exclusion criteria

• Continuous migraine defined as unrelenting headache for a 28 day period
• Must agree not to take non-specific acute medication, such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month (to prevent medication overuse headache)
• PedMIDAS Disability Score > 140, indicating extreme disability that may require more comprehensive, multi-component therapy
• Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)
• Present severe psychiatric disease, alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) or other circumstances, that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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260 participants in 8 patient groups

40 minute session, home practice e-health, phone call

Experimental group

Description:

This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Treatment:

Behavioral: phone call

Behavioral: home practice e-health

Behavioral: 40 minute session

40 minute session, home practice e-health, no phone call

Experimental group

Description:

This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Treatment:

Behavioral: home practice e-health

Behavioral: 40 minute session

40 minute session, home practice handout, phone call

Experimental group

Description:

This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Treatment:

Behavioral: phone call

Behavioral: home practice handout

Behavioral: 40 minute session

40 minute session, home practice handout, no phone call

Experimental group

Description:

This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Treatment:

Behavioral: home practice handout

Behavioral: 40 minute session

20 minute session, home practice e-health, phone call

Experimental group

Description:

This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Treatment:

Behavioral: phone call

Behavioral: 20 minute session

Behavioral: home practice e-health

20 minute session, home practice e-health, no phone call

Experimental group

Description:

This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Treatment:

Behavioral: 20 minute session

Behavioral: home practice e-health

20 minute session, home practice handout, phone call

Experimental group

Description:

This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Treatment:

Behavioral: phone call

Behavioral: 20 minute session

Behavioral: home practice handout

20 minute session, home practice handout, no phone call

Experimental group

Description:

This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Treatment:

Behavioral: 20 minute session

Behavioral: home practice handout