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Development and testing of a behavioral activation mobile therapy for elevated depressivesymptoms

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42MH108219-02
Agency Tracking Number: R42MH108219
Amount: $2,221,831.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 104
Solicitation Number: PA18-579
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-03-01
Award End Date (Contract End Date): 2023-02-28
Small Business Information
Chevy Chase, MD 20815-7007
United States
DUNS: 078733869
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (443) 625-8435
Business Contact
Phone: (202) 670-8020
Research Institution
CHARLESTON, SC 29407-4636
United States

 Nonprofit College or University

Depression is the leading cause of disability worldwide, with more than 300 million people affected. Most adults
with depressive symptoms make at least one annual visit to a primary care physician (PCP). As such, primary
care offers a ripe opportunity to identify and treat adults with depressive symptomatology. Yet, depression has
historically been undertreated in primary care, and more than two-thirds of U.S. adults who screen positive for
depression do not receive treatment. Mobile health (mHealth) technologies, and specifically mobile apps, offer
an ideal strategy to meet the need for evidence-based psychological treatment via primary care. Via our Phase
I STTR, we developed and preliminarily clinically evaluated “Moodivate”, a self-help mobile app depression
treatment informed by the Brief Behavioral Activation (BA) Treatment for Depression. Moodivate was designed
specifically to address the need for disseminable, evidence-based depression treatment via primary care. Our
Phase I STTR was successful in meeting all aims, resulting in publication of both a treatment development paper
and a primary outcomes paper. Specific to feasibility and acceptability, 70% of Moodivate participants recruited
from primary care continued to use the app one month after download and 50% two months after download.
Specific to efficacy, Moodivate (vs. treatment as usual) led to significantly greater decreases in depression over
time, with treatment gains sustained over two-months of follow-up. Although these data are promising, several
key issues must be resolved before Moodivate commercialization. First, although the end user and one customer
for Moodivate is the patient, an additional customer is the healthcare system. Thus, Moodivate must be integrated
with the healthcare system (i.e., with the Electronic Health Record (EHR)) to facilitate provider referral and
monitoring of treatment response. Second, our experience shows that minor product modifications are needed
prior to additional clinical testing and eventual commercialization. Third, to advance toward commercialization
and collect data potentially necessary for FDA approval, a larger-scale clinical trial is needed. Fourth, any
downstream commercialization of Moodivate within healthcare systems requires that we first quantify in financial
terms its cost-effectiveness, both as a stand-alone app and as integrated with the EHR. Thus, the Aims of this
Phase II STTR are to 1) Refine Moodivate and develop the EHR provider portal, 2) Via a three-arm randomized
controlled trial (N=600), examine the efficacy of Moodivate vs. Moodivate + EHR integration vs. treatment as
usual for the treatment of depressive symptoms within primary care, and 3) Conduct a cost-effectiveness
analysis to quantify the financial benefits of Moodivate and Moodivate + EHR implementation within primary
care. Phase II research activities are coupled with a strong commercialization plan which together will propel our
company toward Phase III and will address the public health need for primary care-based depression treatment.PROJECT NARRATIVE
Via a successfully completed Phase I STTR, our investigative team developed and demonstrated the feasibility
and preliminary efficacy of Moodivate, a self-help evidence-based mobile app to be utilized for depression
treatment within primary care. This Phase II STTR will allow us to refine, improve, and rigorously evaluate
Moodivate to ready the product for commercialization. Phase II STTR outcomes will position our company well
within the current movement across healthcare in which traditional care delivery is being replaced with patient-
centric care, facilitated by digital health tools and will address the critical and costly public health need for
psychological depression treatment via primary care.

* Information listed above is at the time of submission. *

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