HeadacheNCT04715685
Mind Body Balance for Pediatric Migraine
A study testing 40 minute session, 20 minute session and home practice e-health in people with Headache and Headache Disorders, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Headache, Headache Disorders, Headache, Migraine
- What is being tested?
- 40 minute session, 20 minute session and home practice e-health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Mar 2021to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read the 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.
- Conditions
- Headache, Headache Disorders, Headache, Migraine, Migraine, Migraine Disorders, Migraine With Aura
- Being tested
- 40 minute session, 20 minute session, home practice e-health, home practice handout, phone call
- Keywords
- headache, migraine, cognitive behavioral therapy, pediatrics, mind body intervention, diaphragmatic breathing, progressive muscle relaxation, imagery, relaxation, biofeedback
- Medical subject headings
- Headache, Headache Disorders, Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 minute sessionBehavioural
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.
20 minute sessionBehavioural
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.
home practice e-healthBehavioural
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.
home practice handoutBehavioural
Participants will be given a handout of commercially available free apps relevant to the mind body skills introduced.
phone callBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 40 minute session, home practice e-health, phone call | Experimental | 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. Receives: Behavioral: 40 minute session; Behavioral: home practice e-health; Behavioral: phone call |
| 40 minute session, home practice e-health, no phone call | Experimental | 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. Receives: Behavioral: 40 minute session; Behavioral: home practice e-health |
| 40 minute session, home practice handout, phone call | Experimental | 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. Receives: Behavioral: 40 minute session; Behavioral: home practice handout; Behavioral: phone call |
| 40 minute session, home practice handout, no phone call | Experimental | 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. Receives: Behavioral: 40 minute session; Behavioral: home practice handout |
| 20 minute session, home practice e-health, phone call | Experimental | 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. Receives: Behavioral: 20 minute session; Behavioral: home practice e-health; Behavioral: phone call |
| 20 minute session, home practice e-health, no phone call | Experimental | 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. Receives: Behavioral: 20 minute session; Behavioral: home practice e-health |
| 20 minute session, home practice handout, phone call | Experimental | 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. Receives: Behavioral: 20 minute session; Behavioral: home practice handout; Behavioral: phone call |
| 20 minute session, home practice handout, no phone call | Experimental | 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. Receives: Behavioral: 20 minute session; Behavioral: home practice handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to post treatment (8 weeks post randomization)
Secondary outcomes (1)
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.
Measured: baseline to post treatment (8 weeks post randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start9 Mar 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Scott Powers, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715685
- Sponsor's protocol ID
- MOST Study
- Other IDs
- U01AT010132
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Balance for Pediatric Migraine
- ClinicalTrials.gov ID
- NCT04715685
- Acronym / sponsor ID
- MOST Study
- Conditions
- Headache, Headache Disorders, Headache, Migraine, Migraine, Migraine Disorders, Migraine With Aura
- Keywords
- headache, migraine, cognitive behavioral therapy, pediatrics, mind body intervention, diaphragmatic breathing, progressive muscle relaxation, imagery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 40 minute session, home practice e-health, phone call | Experimental | Behavioral: 40 minute session, Behavioral: home practice e-health, Behavioral: phone callThis 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. |
| 40 minute session, home practice e-health, no phone call | Experimental | Behavioral: 40 minute session, Behavioral: home practice e-healthThis 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. |
| 40 minute session, home practice handout, phone call | Experimental | Behavioral: 40 minute session, Behavioral: home practice handout, Behavioral: phone callThis 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. |
| 40 minute session, home practice handout, no phone call | Experimental | Behavioral: 40 minute session, Behavioral: home practice handoutThis 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. |
| 20 minute session, home practice e-health, phone call | Experimental | Behavioral: 20 minute session, Behavioral: home practice e-health, Behavioral: phone callThis 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. |
| 20 minute session, home practice e-health, no phone call | Experimental | Behavioral: 20 minute session, Behavioral: home practice e-healthThis 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. |
| 20 minute session, home practice handout, phone call | Experimental | Behavioral: 20 minute session, Behavioral: home practice handout, Behavioral: phone callThis 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. |
| 20 minute session, home practice handout, no phone call | Experimental | Behavioral: 20 minute session, Behavioral: home practice handoutThis 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 minute sessionThe 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. | Behavioural | 40 minute session, home practice e-health, no phone call, 40 minute session, home practice e-health, phone call, 40 minute session, home practice handout, no phone call, 40 minute session, home practice handout, phone call |
| 20 minute sessionFor 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. | Behavioural | 20 minute session, home practice e-health, no phone call, 20 minute session, home practice e-health, phone call, 20 minute session, home practice handout, no phone call, 20 minute session, home practice handout, phone call |
| home practice e-healthParticipants 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. | Behavioural | 20 minute session, home practice e-health, no phone call, 20 minute session, home practice e-health, phone call, 40 minute session, home practice e-health, no phone call, 40 minute session, home practice e-health, phone call |
| home practice handoutParticipants will be given a handout of commercially available free apps relevant to the mind body skills introduced. | Behavioural | 20 minute session, home practice handout, no phone call, 20 minute session, home practice handout, phone call, 40 minute session, home practice handout, no phone call, 40 minute session, home practice handout, phone call |
| phone callThe 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. | Behavioural | 20 minute session, home practice e-health, phone call, 20 minute session, home practice handout, phone call, 40 minute session, home practice e-health, phone call, 40 minute session, home practice handout, phone call |
Primary outcome
Change in number of headache days
Time frame: baseline to post treatment (8 weeks post randomization)
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.
1 secondary outcome
Change in absolute headache disability score on PedMIDAS
Time frame: baseline to post treatment (8 weeks post randomization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Powers, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40 minute session, 20 minute session and home practice e-health in people with Headache and Headache Disorders, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of headache days (time frame: baseline to post treatment (8 weeks post randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.