GOBLUE INTERNATIONAL, LLC — Department of Health and Human Services STTR Phase I: 104

Description

Abstract 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