Protocol for a randomized controlled trial evaluating a digital behavioral self-management intervention for...

Poor disease self-management is a significant issue in migraine in children and adolescents. Comprehensive treatment for migraine may include pharmacological, non-pharmacological, and biobehavioral interventions as well as engagement in healthy habits. With the annual cost of nonadherence in US health care exceeding $300 billion, self-management of chronic conditions is critical to reducing morbidity. Although barriers to self-management are amenable to behavioral intervention/CBT, many adolescents lack the self-management skills to overcome them on their own, and clinic-based self-management efforts have proven inadequate. Additionally, the reach of this treatment is restricted due to limited access (e.g., lack of available trained providers, distance between patient homes and treatment facility). We have addressed these accessibility issues by iteratively developing the first migraine-specific digital therapeutic self-management tool, Migraine Manager. We describe a randomized controlled clinical trial of Migraine Manager on headache frequency, health-related quality of life (HRQOL), and migraine-related disability in 160 adolescents with migraine compared to an attention control arm. We anticipate that participants in the Migraine Manager arm will demonstrate a statistically significant improvement in headache frequency, HRQOL, and migraine-related disability at post-treatment and 3-, 6-, 9-, and 12-month follow-up compared to participants in the attention control arm. If efficacious, Migraine Manager could have a significant impact on public health by providing greater access to evidence-based care in a large proportion of patients who otherwise would not receive treatment, thereby reducing health care disparities for families that have limited access to services and serving as a model for self-management intervention across pediatric populations.