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NCT Number: NCT05889624

Responding With Evidence and Access for Childhood Headaches

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.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Chronic Migraine Headache Disorders Headache Disorders, Primary Headache, Migraine Migraine Migraine Disorders Migraine With Aura Migraine Without Aura Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham Children's of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

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 reinforcement of maladaptive coping. Each session will be about 45 minutes.

Other names: Cognitive Behavioral Therapy

Amitriptyline

Drug

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).

Primary outcomes

  1. Change in number of headache days

    Time frame: baseline to weeks 4-8 to weeks 20-24 (post treatment)

    This outcome measures whether there is a 50% reduction in the number of headaches days based on a self reported daily headache diary, per 28-day period, between the two arms.

  2. Reduction to a PedMIDAS score of 20 or less

    Time frame: baseline to weeks 20-24 (post treatment)

    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 last three months of enrollment).

    This outcome measures whether there is a reduction in migraine related disability measured by the Pediatric Migraine Disability Scale (PedMIDAS) between the two arms. A reduction to a score of 20 or less, indicating mild impact of less is a meaningful outcome for patients and families and considered clinically significant.

Secondary outcomes

  1. Change in absolute reduction in severe headache days

    Time frame: baseline to weeks 20-24 (post treatment)

    This outcome measures whether there is an absolute reduction in the number of severe headache days based on a self-reported daily headache diary, per 28-day period, between the two arms.

  2. Change in absolute headache days

    Time frame: baseline to weeks 4-8 to weeks 20-24 (post treatment)

    This outcome measures whether there is an absolute reduction in the number of headache days based on a self-reported daily headache diary, per 28-day period, between the two arms.

  3. Change in absolute headache disability score on PedMIDAS

    Time frame: baseline to weeks 20-24 (post treatment)

    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 post treatment visit (covering last 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.

  4. Safety and tolerability of treatments (CBT and Amitriptyline)

    Time frame: randomization to weeks 20-24 (post treatment)

    This outcome measures the safety and participant satisfaction of both treatment arms by examining the number of participants who complete the CBT sessions (both arms) and the number of participants who continue to take the Amitriptyline (CBT+pill group).

Other outcomes

  1. Exploratory: Change in self-reported physical and psychosocial functioning (functional impact)

    Time frame: baseline to weeks 20-24 (post treatment)

    The functional disability inventory (FDI) scale evaluates self-reported difficulty in physical health and psychosocial functioning due to physical health. The FDI contains 15 items related to activity limitations that are rated on a 5-point scale (0-no trouble; 4-Impossible). Scores range from 0 to 60, with higher scores indicating greater disability. The total score will be used in this study.

    Questions are answered by the youth in consultation with their parents and reviewed by study staff. The FDI is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment).

  2. Exploratory: Change in self-reported quality of life

    Time frame: baseline to weeks 20-24 (post treatment)

    The Pediatric Quality of Life Inventory (PedsQL) is a measure that is commonly used for comprehensive assessment of the impact of chronic illness. The 23-item pediatric self- and parent-report scales are validated for ages 5-18 and include items covering the domains of Physical, Social, Emotional and School Functioning. A total score is calculated by transforming 0-4 scaled items to a 0-100 scale and computing an average. The total score will be used in this study.

    The PedsQL is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment).

  3. Exploratory: Impact of social determinants of health

    Time frame: baseline

    This exploratory outcome examines the impact of participant demographics (e.g. sex, gender, race, ethnicity, household income, housing, food, and transportation security, zip code) on primary outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

LeighAnn Chamberlin, MEd

CONTACT

[email protected]

513-636-9739

Megan Pfeiffer

CONTACT

[email protected]

513-636-1846

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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