Clinical Research

Evidence Generation Pathway for Limbix Spark

Select Clinical Stage to Explore
Select Clinical Stage to Explore

Feasibility results show a clinically meaningful reduction in adolescent depressive symptoms

Stage 1: Feasibility results show a clinically meaningful reduction in adolescent depressive symptoms

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.

Clinically significant1 reduction in adolescent depressive symptoms

Over half of participants no longer met criteria2 for depression at program completion

Consistent engagement with Spark and assigned modules

Preliminary RCT results show a clinically and statistically significant reduction in depressive symptoms

Stage 2: Preliminary RCT results show a clinically and statistically significant reduction in depressive symptoms

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.

graph based on raw data

High levels of usage compared to depression apps both in research and real-world

Consistently high program completion rates suggest meaningful program engagement in Spark

Upcoming pivotal RCT in partnership with the Duke Clinical Research Institute, funded by the National Institute of Mental Health

Stage 3: Upcoming pivotal RCT in partnership with the Duke Clinical Research Institute, funded by the National Institute of Mental Health

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.

Grounded in Clinically Validated Treatment

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.

Collaborate with Limbix

Interested in partnering for clinical research? Please contact: research@limbix.com

Footnotes

1. Kroenke (2012). Enhancing the clinical utility of depression screening. CMAJ, 184, 281-282 DOI:10.1503/cmaj.1120042.

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

Additional References

McCauley, E., Gudmundsen, G., Schloredt, K., Martell, C., Rhew, I., Hubley, S., & Dimidjian, S. (2015). The Adolescent Behavioral Activation Program: Adapting Behavioral Activation as a Treatment for Depression in Adolescence. Journal of Clinical Child & Adolescent Psychology, 45(3), 291–304. https://doi.org/10.1080/15374416.2014.979933

McCauley, E., Schloredt, K. A., Gudmundsen, G. R., Martell, C. R., & Dimidjian, S. (2016). Behavioral Activation with Adolescents: A Clinician’s Guide (Illustrated ed.). The Guilford Press.

Pass, L., Hodgson, E., Whitney, H., & Reynolds, S. (2018). Brief Behavioral Activation Treatment for Depressed Adolescents Delivered by Nonspecialist Clinicians: A Case Illustration. Cognitive and Behavioral Practice, 25(2), 208–224. https://doi.org/10.1016/j.cbpra.2017.05.003

Pass, L., Lejuez, C. W., & Reynolds, S. (2017). Brief Behavioural Activation (Brief BA) for Adolescent Depression: A Pilot Study. Behavioural and Cognitive Psychotherapy, 46(2), 182–194. https://doi.org/10.1017/s1352465817000443

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