Many legal decisions center on the thoughts or perceptions of some idealized group of individuals, referred to variously as the “average person,” “the typical consumer,” or the “reasonable person.” Substantial concerns exist, however, regarding the subjectivity and vulnerability to biases inherent in conventional means of assessing such responses, particularly the use of self-report evidence. Here, we addressed these concerns by complementing self-report evidence with neural data to inform the mental representations in question. Using an example from intellectual property law, we demonstrate that it is possible to construct a parsimonious neural index of visual similarity that can inform the reasonable person test of trademark infringement. Moreover, when aggregated across multiple participants, this index was able to detect experimenter-induced biases in self-report surveys in a sensitive and replicable fashion. Together, these findings potentially broaden the possibilities for neuroscientific data to inform legal decision-making across a range of settings.

BACKGROUND Depression is a serious, prevalent, recurrent, and under-treated disorder in adolescents. Low levels of treatment-seeking and treatment adherence in this age group, combined with a growing national crisis in access to mental health care, has increased efforts to identify effective treatment alternatives for this demographic. Digital health interventions for mental illness can provide cost-effective, engaging, and accessible means of delivering psychotherapy to adolescents. OBJECTIVE This protocol describes a virtual Randomized Controlled Trial (RCT) designed to evaluate the effectiveness and safety of a self-guided, mobile app-based implementation of Behavioral Activation therapy, SparkRx, for the adjunct treatment of symptoms of depression in adolescents. METHODS Participants are recruited directly through online and print advertisements. Following eligibility screening and consenting, participants are randomly assigned to a Treatment arm (SparkRx) or to a Control arm (assessment-enhanced Usual Care [eUC]) for 5 weeks. The primary effectiveness outcome, total score on the 8-item Patient Health Questionnaire (PHQ-8), is assessed at the end of the 5-week intervention period. Additional participant-reported outcomes are assessed at baseline, post-intervention, and 1-month follow-up. Safety of the intervention is assessed by participant-report (and legal guardian-report, if applicable) and by patterns of symptom deterioration on the PHQ-8, as part of a larger clinical safety monitoring protocol. RESULTS The primary effectiveness outcome, total PHQ-8 score at post-intervention, will be compared between SparkRx and eUC arms using mixed effect modeling, with baseline PHQ-8 and current antidepressant medication status included as covariates. Secondary effectiveness outcomes, including proportion of participants exhibiting treatment response, remission, and minimal clinically-significant improvement (all derived from total PHQ-8 scores), will be compared between groups using chi-square tests. Symptom severity at 1-month follow-up will also be compared between arms. Planned subgroup analyses will examine the robustness of treatment effects to differences in baseline symptom severity (PHQ-8 score <15, ≥ 15) and age (<18, 18+ years). The primary safety outcome, number of psychiatric serious adverse events, will be compared between trial arms using Fisher’s exact test. All other adverse events will be presented descriptively. CONCLUSIONS We hypothesize that results of this trial will support the effectiveness and safety of SparkRx in attenuating symptoms of depression in adolescents. Positive results would more broadly support the prospect of using accessible, scientifically-validated, digital therapeutics in the adjunct treatment of mental health disorders in this age range. CLINICALTRIAL ClinicalTrials.gov NCT05462652

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