Assessing the Efficacy and Safety of a Digital Therapeutic for Symptoms of Depression in Adolescents: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

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