Clinical Research

Limbix Spark Feasibility Study Overview

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.

Stage 1

Stage 2

Stage 3

Feasibility Clinical Trial

COVID-19 Virtual Trial

FDA Pivotal RCT

Stage 1 Results

Clinically significant* reduction in adolescent depressive symptoms

Over half of participants no longer met depression criteria** at program completion

Consistent engagement with Spark and assigned modules

Grounded in Behavioral Activation

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.

Behavioral activation (BA) is a specific CBT technique that aims to increase engagement with activities that promote positive feelings and a sense of accomplishment, to support individuals in reaching their goals through self-monitoring and motivational strategies. 

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. 

By providing rewards that reinforce healthy behaviors and social engagement, BA may be particularly helpful for treating depression in adolescents. A focus on encouraging and reinforcing positive behavior, as opposed to challenging negative thought patterns, may also be appealing to teenagers who struggle with the corrective approach that supports some traditional therapy models.

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* Kroenke (2012). Enhancing the clinical utility of depression screening. CMAJ, 184, 281-282 DOI:10.1503/cmaj.112004

** 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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