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Mind Body Balance for Pediatric Migraine

Primary Purpose

Headache, Headache Disorders, Headache, Migraine

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

40 minute session

20 minute session

home practice e-health

home practice handout

phone call

About this trial

This is an interventional treatment trial for Headache focused on measuring headache, migraine, cognitive behavioral therapy, pediatrics, mind body intervention, diaphragmatic breathing, progressive muscle relaxation, imagery, relaxation, biofeedback

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

University of Colorado/Children's Hospital ColoradoRecruiting
Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

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

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

40 minute session, home practice handout, phone call

40 minute session, home practice handout, no phone call

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

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

20 minute session, home practice handout, phone call

20 minute session, home practice handout, no phone call

Arm 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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in number of headache days

This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between the treatment groups over time. This will be assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days before the endpoint visit.

Secondary Outcome Measures

Change in absolute headache disability score on PedMIDAS

The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this study. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities.

Full Information

NCT ID

NCT04715685

First Posted

January 15, 2021

Last Updated

April 4, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT04715685

Brief Title

Mind Body Balance for Pediatric Migraine

Official Title

Mind Body Balance for Pediatric Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 9, 2021 (Actual)

Primary Completion Date

February 28, 2025 (Anticipated)

Study Completion Date

May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache, Headache Disorders, Headache, Migraine, Migraine, Migraine Disorders, Migraine With Aura, Migraine Without Aura, Chronic Migraine

Keywords

headache, migraine, cognitive behavioral therapy, pediatrics, mind body intervention, diaphragmatic breathing, progressive muscle relaxation, imagery, relaxation, biofeedback

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Only than study staff whose role requires unblinding (project manager and the nurse or interventionist providing the treatment) will be made aware of each participant's study assignment by the statistician. Other study personnel (including assessors of key variables) will remain blinded to treatment assignment.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm 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.

Arm Title

40 minute session, home practice handout, phone call

Arm Type

Experimental

Arm Description

Arm Title

40 minute session, home practice handout, no phone call

Arm Type

Experimental

Arm 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.

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm 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.

Arm Title

20 minute session, home practice handout, phone call

Arm Type

Experimental

Arm Description

Arm Title

20 minute session, home practice handout, no phone call

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

40 minute session

Intervention Description

The 40 minute session will include all of the content contained in the 20 minute session, but will include a greater explanation of each of the mind and body skills, followed by in vivo practice of each skill with the nurse. Sessions will also include review of home practice for each group.

Intervention Type

Behavioral

Intervention Name(s)

20 minute session

Intervention Description

For participants randomized to the 20 minute session, content will include pain education, followed by brief explanations of each of the mind and body skills, in vivo diaphragmatic breathing practice and demonstration of use of biofeedback card. Sessions will also include review of home practice for each group.

Intervention Type

Behavioral

Intervention Name(s)

home practice e-health

Intervention Description

Participants will be provided and instructed on access to a migraine-specific interactive web portal, Migraine e-Health. This web-based tool actively guides participants in practicing evidence-based mind and body skills. Use of the Migraine -e-Health application for the high dose capitalizes on teaching participants mind and body skills while increasing accessibility due to implementation on mobile devices.

Intervention Type

Behavioral

Intervention Name(s)

home practice handout

Intervention Description

Participants will be given a handout of commercially available free apps relevant to the mind body skills introduced.

Intervention Type

Behavioral

Intervention Name(s)

phone call

Intervention Description

The dose of phone call will occur about 4 weeks following the face-to-face mind and body introduction session and will last approximately 5-10 minutes. The phone call will be used to promote adherence to home-practice and answer questions related to skill use/home practice completion.

Primary Outcome Measure Information:

Title

Change in number of headache days

Description

Time Frame

baseline to post treatment (8 weeks post randomization)

Secondary Outcome Measure Information:

Title

Change in absolute headache disability score on PedMIDAS

Description

Time Frame

baseline to post treatment (8 weeks post randomization)

Other Pre-specified Outcome Measures:

Title

Feasibility and adherence to the session time component

Description

Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the session time component a threshold of reasonable feasibility/adherence is specified as: nurse fidelity to introduction dose times (20 min versus 40 min) with fidelity measured as proportion of interactions where the documented time is within 5 minutes of the intended duration (i.e., 15 to 25 minutes for the 20-minute dose and 35 to 45 minutes for the 40-minute dose, as measured by nurse report at the time of the session). The acceptable threshold will be at least 80 percent fidelity within the given time window.

Time Frame

baseline to post treatment (8 weeks post randomization)

Title

Feasibility and adherence to the home practice component

Description

Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the home practice component a threshold of reasonable feasibility/adherence is specified as: eHealth versus handout - threshold >33% of practice days completed on average will be defined as sufficient adherence for both conditions.

Time Frame

baseline to post treatment (8 weeks post randomization)

Title

Feasibility and adherence to the phone call component

Description

Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the phone call component a threshold of reasonable feasibility/adherence is specified as: 50% of phone calls completed will be considered feasible/adherent for the phone call follow-up. No threshold is set for the participants who do not receive a phone call follow-up.

Time Frame

baseline to post treatment (8 weeks post randomization)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

LeighAnn Chamberlin, MEd

Phone

513-636-9739

leighann.chamberlin@cchmc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Powers, PhD

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado/Children's Hospital Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcy Yonker, MD

Phone

720-777-0911

marcy.yonker@childrenscolorado.org

First Name & Middle Initial & Last Name & Degree

Marcy Yonker, MD

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leigh Ann Chamberlin

Phone

513-636-9737

LeighAnn.Chamberlin@cchmc.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mind Body Balance for Pediatric Migraine

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