Responding With Evidence and Access for Childhood Headaches

Официальное название

Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое CBT
  During an 8-week active treatment, participants will receive 6 telehealth CBT sessions, followed by a maintenance phase (16 weeks) when participants will receive 3 "booster" CBT sessions. The sessions will be conducted by teletherapists from the Clinical Coordinating Center at Cincinnati Children's using a standardized treatment manual. A parent/legal guardian will be included in 2 sessions teaching ways to be active coaches, encouraging use of effective coping skills and refraining from reinfor
• Препарат Amitriptyline
  During an 8-week active treatment, participants will begin taking a daily pill (amitriptyline) prescribed and managed clinically by the site headache provider. Amitriptyline will be taken once a day before bedtime. The weight based dosage will gradually be increased based on tolerability and a standardized titration protocol during the 8 week active treatment. The participant will remain on a maximum tolerated dose for the final 16 weeks (maintenance).

Первичные конечные точки

• Change in number of headache days [Срок оценки: baseline to weeks 4-8 to weeks 20-24 (post treatment)]
• Reduction to a PedMIDAS score of 20 or less [Срок оценки: baseline to weeks 20-24 (post treatment)]

Вторичные конечные точки (4)

• Change in absolute reduction in severe headache days [Срок оценки: baseline to weeks 20-24 (post treatment)]
• Change in absolute headache days [Срок оценки: baseline to weeks 4-8 to weeks 20-24 (post treatment)]
• Change in absolute headache disability score on PedMIDAS [Срок оценки: baseline to weeks 20-24 (post treatment)]
• Safety and tolerability of treatments (CBT and Amitriptyline) [Срок оценки: randomization to weeks 20-24 (post treatment)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 15 центров

• University of Alabama at Birmingham Children's of Alabama — Birmingham
• Phoenix Children's Hospital - Barrow Neurological Institute — Phoenix
• University of California San Francisco — San Francisco
• University of Colorado/Children's Hospital Colorado — Aurora
• Nemours Children's Health System — Wilmington
• Clinical Integrative Research Center of Atlanta, Inc — Atlanta
• University of Louisville Health/Norton — Louisville
• Louisiana State Univ/Children's Hospital of New Orleans — New Orleans
• … и ещё 7 центров

Идентификаторы

NCT: NCT05889624 · REACH Study · MP-2021C3-24936

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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