An Evaluation of the Effectiveness of a CBT-Based Digital Therapeutic in Reducing Adolescent Depressive Symptoms

ABSTRACT

Objectives: Adolescent depression's impact is far-reaching, such as an elevated risk of suicide, comorbidities, and functioning impairments. Engaging mobile technology can enhance treatment adherence, and reduce costs and wait times for mental health care. SparkRx is a 5-week, self-guided, CBT-based digital therapeutic app designed to treat adolescents' depressive symptoms. An RCT (NCT04524598) evaluated SparkRx's clinical effectiveness by comparing SparkRx to a psychoeducation control app (Ctrl). Method(s) A total of 160 eligible adolescents (101 female, aged 13-21 years) with self-reported depressive symptoms were recruited nationwide. They were randomized to use SparkRx or Ctrl for 5 weeks and completed a Patient Health Questionnaire-8 (PHQ-8) weekly. Participants (and caregivers if <18) completed pre- and postintervention assessments. Intention-to-treat analyses (ITT) of all participants with moderate to severe baseline symptom severity (PHQ-8 >=10;N = 121) and per protocol (PP) analyses of only those completing all weekly assessments (N = 83) assessed intervention related depressive symptom changes. We examined engagement with SparkRx (daily active users [DAUs], modules completed and number of mood logs and behavioral activations (BAs) scheduled/completed) and symptom change moderators (gender, baseline severity, concurrent treatment, concurrent treatment changes, age, and ADHD diagnosis). Result(s) SparkRx users had clinically meaningful reductions in depressive symptoms (mu = 5.18 in ITT;mu = 5.98 in PP). ITT (SparkRx vs Ctrl) did not reach statistical significance. PP showed that SparkRx significantly reduced depressive symptoms vs Ctrl (p =.023). SparkRx's median DAUs was 41.95%. On average, SparkRx users completed 63.49% of modules, 19.73 (8.32) mood logs, and 8.71 (5.04) BAs (scheduled 9.86 [5.74]). Mixed linear effects models showed no moderating effects. Conclusion(s) SparkRx was shown to reduce adolescent depressive symptoms and was engaging. Limitations included a sample size that was not fully powered. These claims have not been reviewed by the US FDA with regard to SparkRx's safety or efficacy. In October 2021, Limbix released the initial version of SparkRx under FDA's "Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." DDD, ADOL, CBT Copyright © 2022