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Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41MH118130-01
Agency Tracking Number: R41MH118130
Amount: $339,481.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 104
Solicitation Number: PA14-196
Solicitation Year: 2014
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-19
Award End Date (Contract End Date): 2019-09-18
Small Business Information
45 Hickory Dr
Worcester, MA 01609-1016
United States
DUNS: 062780625
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (401) 863-3375
Business Contact
Phone: (203) 464-5001
Research Institution
WORCESTER, MA 01655-0002
United States

 Nonprofit College or University

Worry is a habitual thought process that is observed in individuals with anxiety disordersA leading theory
posits that although worrying may be unpleasantthe immediate emotions that are avoided by concentrating on
worry are often perceived as more aversiveegfearangergriefFrom a mechanistic perspectiveworry is
thought to be learned and reinforced in a similar manner to other types of operantly conditioned behaviorsThereforewith cycles of reinforcement learningthe individual with an anxiety disorder learns a maladaptivedistracting thinking style that uses worry to focus on the future rather than the presentWorry is a major
obstacle to sleepthrough increasing physiological arousalThusthere is an important need to develop
treatments that decrease worry thinkingas they may have significant impact on both anxiety and sleepMindfulness training involves focusing on cognitiveaffectiveand physiological experiences occurring in the
present momentMindfulness teaches individuals to focus on current thoughtsfeelingsand physiological
sensationsno matter what the present experience might entailAs suchone may learn to consciously act
rather than unconsciously react to external or internal stimuliWith mindfulness practiceindividuals learn to
move away from maladaptive habitual thought processessuch as worry as a distraction strategyWe have
developed a digital therapeutic program for anxiety that delivers mindfulness training via an app based
platform to help adults overcome anxietyUnwinding AnxietyWe have designed it to mechanistically target
the reinforcement learning processWe propose to develop and adapt Unwinding Anxiety specifically for
individuals with generalized anxiety disorderOur aims are todevelop and refine Unwinding Anxiety for
individuals with generalized anxiety disorderdetermine user engagement and acceptability as well as
measure effect sizes of the program vstreatment as usualandpreliminarily test mechanisms of actionThe knowledge gained will set the stage for a number of future studies related to further elucidating the
mechanisms of mindfulnessand the clinical efficacy and utility of this type of training delivered via digital
therapeutics in generalSpecificallythis study will provide necessary variances for powering larger phasestudies Project Narrative Statement
Mindfulness training may help people manage anxietybut the effects of delivering mindfulness
training through a digital platformapp based digital therapeuticshas yet to be studiedThe
proposed study will test a mobile mindfulness training program for generalized anxiety disorderto help individuals decrease worry

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

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