# Automating and Obtaining FDA Approval for a Digital Intervention for Depression

> **NIH NIH R44** · HEALTH RHYTHMS, INC. · 2020 · $974,672

## Abstract

Phase IIB Abstract -FINAL
A large body of evidence supports the idea that disruptions in the regularity of behavioral routines (or ‘social rhythms’) can lead
to the onset of mood symptoms and full-blown episodes via their impact on endogenous circadian rhythms and, conversely,
that stable social routines protect against new mood episodes. Based on our conviction that monitoring, evaluating, and
increasing the regularity of behavioral rhythms has broad applicability for improving mental health, we established
HealthRhythms, Inc. (www.healthrhythms.com) with the goal of using mobile technology to enhance our capacity to monitor
and treat such conditions, with a particular emphasis on mood disorders.
Our product vision capitalizes on the ubiquity and intimacy of smartphones and their capacity to automatically and continuously
sense parameters of behavior that represent key indicators of depressive symptomatology captured on a 24/7 basis in the user’s
natural environment. It also capitalizes on the capacity of smartphones to deliver interventions that are easily accessible, can be
delivered with optimal timing and, perhaps most important, are enormously scalable. Finally, smartphone technology gives us
the capacity to bring empirically validated psychosocial interventions to the hundreds of thousands of depressed patients who
otherwise would not be able to access such interventions and, thus, speed their recovery and prevent relapse.
Under the auspices of our Phase II SBIR funding (R44MH113520-01-02), we have developed both such a monitoring product
(Measure) and have developed and tested such a digital intervention platform (Cue). Analyses conducted to date indicate that
Cue leads to significantly greater decreases in depressive symptomatology than monitoring alone via Measure. We now propose
to: 1) upgrade to Cue and its accompanying clinician dashboard to be commercially marketable and 2) carry out the clinical trial
necessary for FDA licensing of Cue 2.0 as a mobile device. Cue 2.0 will include enhanced designs, more in-depth
psychoeducational material, and a fully automated engine for delivering behavior change suggestions to improve the regularity
of users’ social and behavioral routines. Building on the accomplishments of our Phase II funding, this SBIR Phase IIB proposal
is focused on bringing Cue to market as a scientifically validated and profitable digital intervention for individuals with depression
with or without co-occurring anxiety disorder. The Specific Aims are: Aim 1: Develop and validate Cue 2.0 a fully automated
digital intervention platform. Aim 2: Carry out all necessary steps to apply for FDA licensing of Cue 2.0.

## Key facts

- **NIH application ID:** 10081882
- **Project number:** 2R44MH113520-03
- **Recipient organization:** HEALTH RHYTHMS, INC.
- **Principal Investigator:** Ellen Frank
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $974,672
- **Award type:** 2
- **Project period:** 2017-08-15 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10081882

## Citation

> US National Institutes of Health, RePORTER application 10081882, Automating and Obtaining FDA Approval for a Digital Intervention for Depression (2R44MH113520-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10081882. Licensed CC0.

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