Clinical trial NCT05889624: Responding With Evidence and Access for Childhood Headaches
Official title: Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)
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
diaphragmatic breathing
progressive muscle relaxation
imagery
relaxation
biofeedback
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.

Detailed description: Migraine is the second most disabling disease in the world. Research has primarily focused on treating migraine in adults; however, approximately 10% of children and adolescents have migraine, suggesting that up to 7 million youth are impacted in the United States alone. Given that the majority of youth have migraine symptoms that persist into adulthood, there is a critical need to identify and improve access to the most effective preventive migraine treatments for this population as a means of reducing the long-term healthcare burden and functional impairment of this illness.

This comparative effectiveness study will test CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) to CBT alone.

Participants will be involved in the study for approximately 28 weeks, with the first 4 weeks being a baseline period and the next 8 weeks involving six telehealth CBT sessions for both study groups (CBT while taking a clinically-prescribed pill-based prevention therapy \[amitriptyline\] compared to CBT alone), and dose titration of clinically-prescribed medication (amitriptyline) for the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group. During the remaining 16 weeks the participants will maintain the dose of medication (in the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group) and attend "booster" CBT sessions held three times over 4 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee. (includes presentation with or without medication overuse headache as well)
* Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization
* Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine
* English fluency: Able to complete the study visits and questionnaires in English

Exclusion Criteria:

* Current treatment includes amitriptyline and/or CBT specific to headache care
* Current prescribed preventive antimigraine medication within a period equivalent to \< 5 half-lives of that medication before entering the baseline phase
* Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention
* Youth who are pregnant
* Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis
* Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant

Primary outcomes:
measure: Change in number of headache days
timeFrame: baseline to weeks 4-8 to weeks 20-24 (post treatment)
measure: Reduction to a PedMIDAS score of 20 or less
timeFrame: baseline to weeks 20-24 (post treatment)
Secondary outcomes:
measure: Change in absolute headache disability score on PedMIDAS
timeFrame: baseline to weeks 20-24 (post treatment)
measure: Change in absolute headache days
timeFrame: baseline to weeks 4-8 to weeks 20-24 (post treatment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Children's of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital - Barrow Neurological Institute
state: Arizona
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado/Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Nemours Children's Health System
state: Delaware
city: Atlanta
country: United States
facility: Clinical Integrative Research Center of Atlanta, Inc
state: Georgia
city: Louisville
country: United States
facility: University of Louisville Health/Norton
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State Univ/Children's Hospital of New Orleans
state: Louisiana
city: Amherst
country: United States
facility: Dent Neurological Institute
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Childrens
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Science Center/ LeBonheur Children's Hospital
state: Tennessee
city: Huntington
country: United States
facility: Marshall Health
state: West Virginia
Study officials:
affiliation: Cincinnati Childrens Medical Center, Cincinnati
name: Scott Powers, PhD
role: PRINCIPAL_INVESTIGATOR
References: