Protocol for a randomized controlled trial evaluating a digital behavioral self-management intervention for adolescent migraine
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 160 participants or records.
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