POSIT SCIENCE CORP — Department of Health and Human Services SBIR Phase I: 104

Description

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 PROJECT NARRATIVE The goal of this project is to further develop to pivotal trial readiness and evaluate a multimodal closed loop assess andgt treat adjunct to treatment mobile application designed for the treatment of adults with mood disorders This unique individualized mobile treatment and monitoring strategy should help bridge the gap between patients and clinical care and may hence benefit a large population of adults that suffer from mood disorders and lack of long term viable treatment options