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September 10, 2026Headache The Journal of Head and Face PainOpen Access

Responding With Evidence and Access for Childhood Headaches ( REACH ) study: A comparative effectiveness trial of cognitive behavioral therapy monotherapy versus combined cognitive behavioral therapy–pharmacotherapy with amitriptyline for the prevention of childhood migraine—The study protocol

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Authors

EFEstée C. H. FeldmanMEMichelle M. ErnstMMMaya Marzouk

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Overview

Randomized trial protocol reveals a comparative effectiveness design evaluating cognitive behavioral therapy versus amitriptyline in pediatric migraine, highlighting nonpharmacologic treatment...

Key Points

  • Determine whether cognitive behavioral therapy monotherapy delivered via telehealth is noninferior or superior to combined cognitive behavioral therapy and amitriptyline pharmacotherapy for pediatric migraine prevention.
  • Randomized comparative effectiveness trial enrolling youth aged 10–17 years from 15 multicenter sites across the United States.
  • Participants are randomly assigned to either cognitive behavioral therapy alone or cognitive behavioral therapy plus dose-titrated amitriptyline, receiving six telehealth sessions and three booster sessions over 6 months.
  • Headache frequency and disability are monitored using a daily headache diary across a 28-day baseline, active treatment, and a 28-day post-intervention assessment period.
  • Protocol-defined primary endpoints are achieving a ≥50% reduction in headache days and reducing functional disability to a Pediatric Migraine Disability Assessment score ≤20.
  • Analyses are planned to determine whether behavioral teletherapy alone achieves outcomes comparable to combined drug therapy while avoiding medication-related adverse effects.

Cite This Study

Feldman et al. (2026) studied this question.

synapsesocial.com/papers/6aa27a8e58559d80afc73348https://doi.org/10.1111/head.70176
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