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.

Migraine is one of the most common chronic health problems in children and adolescents, resulting in high levels of functional disability. Symptoms frequently persist into and impact the course of adulthood for affected individuals. Current practice recommendations include a combined therapy approach of preventive medication and cognitive behavioral therapy (CBT); however, no trials have systematically assessed whether a combined therapy approach is superior to a cognitive behavioral monotherapy intervention. The REACH (Responding With Evidence and Access for Childhood Headaches) trial will compare the impact of a CBT monotherapy to a combined treatment for prevention of migraine in youth, while addressing barriers to CBT access by utilizing a teletherapy approach. The study will include youth with migraine between the ages of 10 and 17 years from 15 sites across the United States, who will be randomly assigned to a CBT + pill (amitriptyline) group or CBT-alone group. Both groups will complete six sessions of telehealth CBT, as well as three booster sessions, over the course of 6 months. Participants will report on headache and migraine frequency and related disability via a daily headache diary before (28-day baseline), during, and after completion of the intervention (the last 28 days on the protocol). The CBT + pill group will also undergo a dose titration of clinically prescribed amitriptyline throughout the active treatment phase. Primary treatment outcomes are a ≥50% reduction in headache days and reduction in migraine-related disability (i.e., Pediatric Migraine Disability Assessment score ≤20). Findings of the REACH study may confirm current practice guidelines or provide evidence of comparable effectiveness of combined therapy and CBT monotherapy for prevention of migraine. This trial is designed to reinforce current guidelines for preventive headache management strategies in youth with migraine. The study will also advance knowledge by determining whether CBT alone, without the potential side effects of medication, is sufficient.