Clinical trial NCT04715685: Mind Body Balance for Pediatric Migraine
Official title: Mind Body Balance for Pediatric Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-01-20
Enrollment: 260
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in number of headache days
timeFrame: baseline to post treatment (8 weeks post randomization)
Secondary outcomes:
measure: Change in absolute headache disability score on PedMIDAS
timeFrame: baseline to post treatment (8 weeks post randomization)
Other outcomes:
measure: Feasibility and adherence to the session time component
timeFrame: baseline to post treatment (8 weeks post randomization)
measure: Feasibility and adherence to the home practice component
timeFrame: baseline to post treatment (8 weeks post randomization)
measure: Feasibility and adherence to the phone call component
timeFrame: baseline to post treatment (8 weeks post randomization)
Locations:
city: Aurora
country: United States
facility: University of Colorado/Children's Hospital Colorado
state: Colorado
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Scott Powers, PhD
role: PRINCIPAL_INVESTIGATOR
References: