A Cbt-based Prescription Digital Therapeutic Is Effective in Reducing Symptoms of Depression in Adolescents

Background: Depression is the most common mental health disorder among adolescents with continued increases in prevalence. The impacts of depression are far-reaching and include an increased risk of suicide, increased likelihood for comorbid health concerns, and long-lasting impairments in academic, work, and social functioning. Pediatric primary care guidelines recommend that all adolescents be screened for depression annually, but effective treatment options and immediate access to specialized mental healthcare are often limited. Limbix Spark [1] is a 5-week, self-guided, cognitive behavioral therapy (CBT)-based, prescription digital therapeutic (PDT) mobile application designed to treat depressive symptoms in adolescents within primary care settings. To evaluate the clinical effectiveness of Limbix Spark as a treatment for depressive symptoms during the COVID-19 pandemic, a virtual randomized controlled trial (RCT; NCT04524598) was conducted to compare Limbix Spark to a psychoeducation control mobile app.

Methods: A community sample of 159 eligible adolescents (101 female; 43 male; 15 non-binary), aged 13-21, with self-reported symptoms of depression were recruited nationwide to participate in the RCT. Participants were randomly assigned to use either the Spark or the control app for the five week intervention period. Participants and their legal guardians (if under 18) completed pre and post-intervention questionnaires and participants completed weekly in-app PHQ-8 assessments. Intervention-related changes in depression symptoms (PHQ-8) and secondary outcomes including anxiety (GAD-7), global health (PROMIS), parent-reported outcomes, as well as app usage were evaluated. Data collection is ongoing and interim analyses in 62 participants (40 female; 14 male; 8 nonbinary), with moderate-severe levels of depression symptoms (PHQ-8 ≥ 10), have been conducted.

Results: Interim results showed a clinically significant reduction in depressive symptoms in the Spark group (mean = 5.7) and a statistically significant (p = 0.043) reduction in depressive symptoms between Spark and the control arm (Figure 1a). The Spark app was also associated with a decrease in anxiety symptoms (p = 0.02; Figure 1b) and reductions in parent-reported mood symptoms (p = 0.0003). There was high engagement in Spark compared to depression apps implemented both in research and real-world settings (Figure 2) and participants rated the app as highly enjoyable.

Conclusion: Preliminary evidence demonstrates that Limbix Spark reduces depression symptoms in adolescents and is a highly engaging and enjoyable experience compared to other apps on the market. For pediatric primary care physicians, Limbix Spark can serve as an immediate and readily available treatment for depression symptoms and increase critical early access to mental health care for their adolescent patients.