Responding With Evidence and Access for Childhood Headaches

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: CBT; Drug: Amitriptyline

Study type: Interventional

Funder types: Other

Identifiers

NCT05889624

REACH Study (Other Identifier)

MP-2021C3-24936 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline)

Experimental group

Description:

This intervention consists of Cognitive Behavioral (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. This arm will also take a daily oral dose of Amitriptyline, which will be clinically prescribed and managed by the patient's headache provider.

Treatment:

Drug: Amitriptyline

Behavioral: CBT

CBT alone

Experimental group

Description:

This intervention arm consists of 6 Cognitive Behavioral Therapy (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.

Treatment:

Behavioral: CBT