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.
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
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
Parallel
CBT
BehavioralDuring 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.
Amitriptyline
DrugDuring 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).
Change in number of headache days
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.
Reduction to a PedMIDAS score of 20 or less
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.
Change in absolute reduction in severe headache days
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.
Change in absolute headache days
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.
Change in absolute headache disability score on PedMIDAS
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.
Safety and tolerability of treatments (CBT and Amitriptyline)
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).
Exploratory: Change in self-reported physical and psychosocial functioning (functional impact)
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).
Exploratory: Change in self-reported quality of life
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).
Exploratory: Impact of social determinants of health
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.
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Children's Hospital Medical Center, Cincinnati
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator