In 2019, Limbix conducted a registered clinical trial (NCT04165681) focused on assessing feasibility and early evidence of efficacy for Limbix Spark in adolescents with depressive symptoms. A total of 30 participants between the ages of 12 and 21 were enrolled in the single-arm trial and asked to complete the 5-week, self-guided Limbix Spark program at home. Participants completed weekly PHQ-8 assessments in the Limbix Spark app during the intervention, as well as self-reported measures and qualitative interviews at a post-intervention site visit. Participants also completed a 1-month follow-up questionnaire by email.
Limbix is conducting a registered, fully-remote randomized controlled clinical trial (NCT04524598) evaluating the clinical effectiveness and safety of Limbix Spark in adolescents (13-21) with depressive symptoms. Preliminary evidence shows a clinically significant reduction in depressive symptoms when using Spark and a statistically significant (p = 0.043) reduction in depressive symptoms when compared to a psychoeducational control arm.
Limbix has been awarded a Fast Track Phase I/II Small Business Innovation Research (SBIR) grant providing up to $3.6M from the National Institute of Mental Health (NIMH). The grant will support the clinical validation of Limbix Spark in a large-scale pivotal trial in partnership with the Duke Clinical Research Institute.
The Duke Clinical Research Institute (DCRI) is the world’s largest academic research organization and a leader in the advancement of digital health technologies. The Limbix-DCRI pivotal RCT is scheduled to begin in 2021.
Cognitive-behavioral therapy (CBT) has been shown to be effective in the prevention and treatment of depression in children and adolescents, and is recommended as a first-line treatment for depression by the American Academy of Pediatrics.
Because certain neural systems in the brains of adolescents are still developing, teenagers demonstrate more reward-seeking behaviors than adults and have a greater tendency to engage in harmful and avoidant behaviors during depressive episodes.
Reinforcing healthy behaviors and social engagement may be particularly helpful for treating depression in adolescents. A focus on psychoeducation and encouraging and reinforcing positive behavior may also be appealing to teenagers who struggle with the corrective approach that supports some traditional therapy models.
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2. Wu et al. (2019). Equivalency of the diagnostic accuracy of the PHQ-8 and PHQ-9: a systematic review and individual participant data meta-analysis. Psychol Med, doi: 10.1017/S0033291719001314
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