The study, expected to begin enrollment in May 2023, will evaluate whether cognitive behavioral therapy delivered by telehealth reduces headache days and disability from migraine compared with CBT plus a preventive medication.
According to a recent announcement, investigators at Cincinnati Children’s Hospital have been approved for a $12.9 million Patient-Centered Outcomes Research Institute (PCORI) award to lead a 15-site, large-scale study evaluating the impact virtually delivered cognitive behavioral therapy (CBT) has on patients with migraine.1
Led by Scott Powers, PhD, Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical Center, the project will evaluate whether CBT telehealth can reduce headache days and disability as effectively as CBT telehealth plus a preventive medication (amitriptyline). The study, which will include youths with migraine aged 10 to 17 years, is expected begin recruitment in May 2023, with several participating centers across the US.
"This study was selected for PCORI funding for its potential to provide real-world data on the comparative effectiveness of medication and nonpharmacologic treatments for the prevention of migraine among pediatric patients,” Nakela Cook, MD, MPH, executive director, PCORI, said in a statement.1 “We look forward to following the study's progress and working with Cincinnati Children's to share the results."
Powers and his colleagues at Cincinnati Children’s are no strangers to this type of research, and, in fact, have contributed to the growth of nonmedication approaches over the years. In 2020, Andrew D. Hershey, MD, PhD, FAHS, Endowed Chair and director of neurology at Cincinnati Children’s, and colleagues conducted a basic mechanistic study examining the changes in brain activation and resting-state connectivity after 8 weeks of CBT in youths with migraine. After completing the weekly sessions, patients reported headache frequency decreases from 15 (±7.4) headaches per month to 10 (±7.4; P <.001). Additionally, greater brain activations from frontal regions involved in cognitive regulation of pain were observed, along with increased connectivity between the amygdala and frontal regions.2
Most recently, in 2021, Powers and experts at the University of Iowa published a 3-year follow-up study to the pivotal CHAMP trial (NCT01581281), which randomized participants to amitriptyline, topiramate (Topamax; Janssen), or placebo. At the end of the trial, the study drug was stopped, and participants received clinical care of their choice thereafter. Conducted between May 2012 and November 2015, the follow-up included time points between June 2013 and June 2018.3
Over the course of the 3-year follow-up, participants consistently maintained meaningful reductions in headache days (mean headache days per 28 days: CHAMP baseline, 11.1 [standard deviation (SD), 6.0] days; CHAMP completion, 5.0 [SD, 5.7] days; 3-year follow-up, 6.1 [SD, 6.1] days) and disability (mean score: CHAMP baseline, 40.9 [SD, 26.4]; CHAMP completion, 17.9 [SD, 22.1]; 3-year follow-up, 12.3 [SD, 20.0]). At 3 years after completion of the CHAMP trial, headache days were approximately 1.5 per week (changed from about 3 per week at trial baseline) and disability had improved from the moderate range to the low mild range on the PedMIDAS.
Powers and his colleagues concluded that the survey study could be used to inform use and discontinuation timing of pharmacological therapies for migraine in youth ages 8 to 17, but that further research is needed to examine the mechanisms of treatment improvement and maintenance.