IMPORTANCE: Early, safe, effective, and durable evidence-based interventions for children and adolescents with chronic migraine do not exist. OBJECTIVE: To determine the benefits of cognitive behavioral therapy (CBT) when combined with amitriptyline versus headache education plus amitriptyline. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of 135 youth (79% female) aged 10 to 17 years diagnosed with chronic migraine (> 15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to the CBT plus amitriptyline group (n = 64) or the headache education plus amitriptyline group (n = 71). The study was conducted in the Headache Center at Cincinnati Children's Hospital between October 2006 and September 2012; 129 completed 20-week follow-up and 124 completed 12-month follow-up. INTERVENTIONS: Ten CBT versus 10 headache education sessions involving equivalent time and therapist attention. Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit. In addition, follow-up visits were conducted at 3, 6, 9, and 12 months. MAIN OUTCOMES AND MEASURES: The primary end point was days with headache and the secondary end point was PedMIDAS (disability score range 0 to 240 points; 0 to 10 for little to none, 11 to 30 for mild, 31 to 50 for moderate, > 50 for severe); both end points were determined at 20 weeks. Durability was examined over the 12-month follow-up period. Clinical significance was measured by a 50% or greater reduction in days with headache and a disability score in the mild to none range (< 20 points). RESULTS: At baseline, there were a mean (SD) of 21 (5) days with headache per 28 days and the mean (SD) PedMIDAS was 68 (32) points. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group versus 6.8 for the headache education plus amitriptyline group (difference 4.7 (95% CI 1.7 to 7.7) days; p = 0.002). The PedMIDAS decreased by 52.7 points for the CBT group versus 38.6 points for the headache education group (difference 14.1 (95% CI 3.3 to 24.9) points; p = 0.01). In the CBT group, 66% had a 50% or greater reduction in headache days versus 36% in the headache education group (odds ratio 3.5 (95% CI 1.7 to 7.2); p < 0.001). At 12-month follow-up, 86% of the CBT group had a 50% or greater reduction in headache days versus 69% of the headache education group; 88% of the CBT group had a PedMIDAS of less than 20 points versus 76% of the headache education group. Measured treatment credibility and integrity was high for both groups. CONCLUSIONS AND RELEVANCE: Among young persons with chronic migraine, the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline. These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00389038.

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