PROJECT SUMMARY
The goal of the current project is to elaborate upon, reconstruct and advance to pivotal trial readiness a
multimodal, closed loop assessment-to-treatment mobile application for individuals with mood disorders.
Major Depressive Disorder (MDD) is a recurrent and disabling condition, and a leading cause of global
disease burden. Nearly half of the patients fail to respond to psychological or pharmacological treatments due
in part to inaccessibility of treatments outside the clinic, discontinuity of connection with treatment providers
and difficulty in complying with demanding treatment regimens.
In the current proposal, we aim to bridge these large treatment gaps by finalizing the development of
Moodify, a mobile mental health application designed to provide continuous, multi-modal mood monitoring and
individualized treatments via a closed-loop algorithm. Moodify is designed to be used as an adjunct to
conventional treatment, allowing clinicians to remotely track their patients’ status and changes in mood
between clinic visits, and to refine treatment parameters to maximize potential treatment benefits. Moodify’s
innovative assessment approach documents mood using a combination of active and passive monitoring
strategies; It’s innovative treatment approach uses a closed-loop algorithm that determines, based on current
mood state reading and the patient’s status, which treatment to apply, how to apply it and when to apply it, in
an effort to optimize treatment benefits. The Moodify platform supports delivery of various treatment options,
including CBT, relaxation techniques and plasticity-based cognitive training. Preliminary testing of initial
prototypes of Moodify in MDD patients and matched controls showed promising results of the Moodify
approach, demonstrating its effectiveness in capturing mood states quickly and reliably over time.
In the proposed project, we plan to finalize Moodify’s development, to ensure users engagement over
longer time periods, and conduct a feasibility trial in the target population of patients with MDD, monitored by
their clinicians. In the first specific aim, we will improve upon existing beta version of the application with
feedback from small focus groups composed of individuals with mood disruption and clinicians to ensure that
the user experience and the user interface are sufficient to motivate four weeks of program use. Using
established methods of software design and development, we will iteratively refine the implemented design to
complete the development of the enhanced program and conduct the feasibility trial. At the completion of this
project we will have data sufficient to propose a multi-site, randomized, controlled medical device trial designed
to establish medical claims defining the efficacy of this mobile program.