# Limbix Spark: a CBT-based mobile intervention for adolescent depression

> **NIH NIH R44** · LIMBIX HEALTH, INC. · 2021 · $449,928

## Abstract

Project Abstract
Depression affects more than 3.2 million adolescents in the USA, with rising incidence and suicide rates that
carry devastating personal, societal, and economic impact. Effective care for adolescent depression is limited
due to lack of access, shortage of providers, long waitlists, stigma, and ineffective or partially effective
pharmacological options. Many adolescents with depression are initially diagnosed and receive treatment from
primary care providers, who, unfortunately, often have limited time, training, and options to be effective
gatekeepers for treatment. There is an urgent need for accessible, cost-effective, and clinically-validated
treatment options for adolescents diagnosed with depression, particularly in primary care settings. Digital
health interventions represent an exciting and promising new direction for mental health treatment with strong
potential to increase access to care. Such technology is especially critical and timely during this period of
mandated physical distancing, which is expected to increase social isolation and exacerbate difficulties in
receiving care. Currently available commercial digital health options widely lack clinical validation, cannot make
strong medical claims, and are not specifically designed for adolescents. We aim to develop an FDA-cleared,
self-guided, cognitive behavioral therapy (CBT)-based mobile program (Limbix Spark) to be prescribed by
primary care providers and psychiatrists and commercialized for at-home patient use as first line treatment.
Limbix Spark implements behavioral activation, a key CBT skill that provides a sense of pleasure or mastery
through self-monitored activities to reduce depressive symptoms and improve functional outcomes. Given
youth ease with and preference for technological solutions, an age-appropriate and engaging mobile
intervention can be both beneficial and enjoyable. Building on outcomes from a feasibility trial demonstrating
high feasibility and engagement, and preliminary evidence of clinically meaningful reductions in depressive
symptoms, in Phase I of the proposed Fast Track, we will conduct rigorous testing to optimize our Limbix Spark
program and show high usability, build a regulatory compliant platform, and prepare for a Phase II clinical trial.
In Phase II, we will demonstrate clinical effectiveness of Limbix Spark by conducting a double-blind, placebo
controlled, randomized clinical trial with patients recruited and enrolled from primary care and psychiatric
clinics. The team, led by veteran entrepreneurs, research professionals, industry leaders, and clinical experts,
is singularly qualified to conduct the proposed research and commercialize Limbix Spark as an adolescent
depression prescription digital therapeutic, accelerating access to care for a severely underserved population.

## Key facts

- **NIH application ID:** 10151241
- **Project number:** 1R44MH125636-01
- **Recipient organization:** LIMBIX HEALTH, INC.
- **Principal Investigator:** SCOTT N COMPTON
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $449,928
- **Award type:** 1
- **Project period:** 2021-02-01 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10151241

## Citation

> US National Institutes of Health, RePORTER application 10151241, Limbix Spark: a CBT-based mobile intervention for adolescent depression (1R44MH125636-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10151241. Licensed CC0.

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