Study to Evaluate Efficacy of Telehealth Cognitive Behavioral Therapy for Migraine

Study will analyze whether cognitive behavioral therapy telehealth can lower headache days and disability as effectively as cognitive behavioral therapy plus a preventive medication for migraine.

A new study will analyze the efficacy of cognitive behavioral therapy (CBT) delivered via telehealth in decreasing total headache days and disability from migraine vs CBT plus a preventive medication.

The study will be led by researchers from Cincinnati Children’s Hospital, who were granted a $12.9 million Patient-Centered Outcomes Research Institute (PCORI) award for a 15-site, large-scale evaluation of the impact of virtually delivered CBT on patients with migraine.1

The researchers, led by Scott Powers, PhD, Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical Center, will analyze whether CBT telehealth can lower headache days and disability as effectively as CBT telehealth plus amitriptyline, a preventive medication for migraine. The study will include individuals with migraine 10 to 17 years of age and is expected begin recruiting subjects in May 2023 from several participating centers across the United States.

"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 press release.“We look forward to following the study's progress and working with Cincinnati Children's to share the results."

The research team from Cincinnati Children’s Hospital Medical Center previously contributed to the growth of nonmedication treatment efforts for migraine in recent years. In 2020, Andrew D. Hershey, MD, PhD, FAHS, endowed chair and director of neurology at the hospital, led a team who conducted a basic mechanistic study on alterations in brain activation and resting-state connectivity following 8 weeks of CBT in youths with migraine.

After the completion of weekly sessions, patients reported headache frequency reductions from 15 (±7.4) headaches per month to 10 (±7.4; <.001). Further, the researchers noted increased brain activations from frontal regions involved in cognitive regulation of pain as well as greater connectivity between the amygdala and frontal regions.2

In 2021, Powers and investigators from the University of Iowa published a 3-year follow-up study to the pivotal CHAMP trial (NCT01581281), in which individuals were randomized to amitriptyline, topiramate (Topamax; Janssen), or placebo. The study was conducted between May 2012 and November 2015, with follow-up time points between June 2013 and June 2018. The study drug was halted at the end of the trial, at which point participants were administered clinical care of their choice.3

During the 3-year follow-up, participants were able to consistently maintain meaningful decreases 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]).

Three years after completion of the CHAMP trial, headache days dropped from approximately 3 per week at trial baseline to 1.5 per week, whereas disability improved from moderate to low mild on the PedMIDAS.

The investigators noted that the survey study could help inform use and discontinuation timing of pharmacological therapies for migraine in individuals 8 to 17 years of age; however, additional research is needed to evaluate the mechanisms of treatment improvement and maintenance.

References
1. 15-site trial to compare telehealth cognitive behavioral therapy alone and with medication to prevent migraine in youth. News release. Cincinnati Children’s Hospital Medical Center. July 26, 2022. Accessed July 28, 2022. https://www.prnewswire.com/news-releases/15-site-trial-to-compare-telehealth-cognitive-behavior-therapy-alone-and-with-medication-to-prevent-migraine-in-youth-301593257.html
2. Nahman-Averbuch H, Scheiner VJ, Chamberlin LA, et al. Alterations in brain function after cognitive behavioral therapy for migraine in children and adolescents. Headache. 2020;60(6):1165-1182. doi:10.1111/head.13814
3. Powers SW, Coffey CS, Chamberlin LA, et al. Prevalence of headache days and disability 3 years after participation in the Childhood and Adolescent Migraine Prevention Medication trial. JAMA Netw Open. 2021;4(7):e2114712. doi:10.1001/jamanetworkopen.2021.14712