Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
Award last edited on: 3/26/2019

Sponsored Program
Awarding Agency
Total Award Amount
Award Phase
Solicitation Topic Code
Principal Investigator
Judson A Brewer

Company Information

Mindsciences Inc (AKA: Goblue International LLC~Claritas Mindsciences)

45 Hickory Drive
Worcester, MA 01609
   (617) 863-7703

Research Institution

University of Massachusetts Medical

Phase I

Contract Number: 1R41MH118130-01
Start Date: 9/19/2018    Completed: 9/18/2019
Phase I year
Phase I Amount
Worry is a habitual thought process that is observed in individuals with anxiety disorders. A leading theory posits that although worrying may be unpleasant, the immediate emotions that are avoided by concentrating on worry are often perceived as more aversive (eg, fear, anger, grief). From a mechanistic perspective, worry is thought to be learned and reinforced in a similar manner to other types of operantly conditioned behaviors. Therefore, with cycles of reinforcement learning, the individual with an anxiety disorder learns a maladaptive, distracting thinking style that uses worry to focus on the future rather than the present. Worry is a major obstacle to sleep, through increasing physiological arousal. Thus, there is an important need to develop treatments that decrease worry thinking, as they may have significant impact on both anxiety and sleep. Mindfulness training involves focusing on cognitive, affective, and physiological experiences occurring in the present moment. Mindfulness teaches individuals to focus on current thoughts, feelings, and physiological sensations, no matter what the present experience might entail. As such, one may learn to consciously act rather than unconsciously react to external or internal stimuli. With mindfulness practice, individuals learn to move away from maladaptive habitual thought processes, such as worry as a distraction strategy. We have developed a digital therapeutic program for anxiety that delivers mindfulness training via an app-based platform to help adults overcome anxiety (Unwinding Anxiety). We have designed it to mechanistically target the reinforcement learning process. We propose to develop and adapt Unwinding Anxiety specifically for individuals with generalized anxiety disorder. Our aims are to (1) develop and refine Unwinding Anxiety for individuals with generalized anxiety disorder, (2) determine user engagement and acceptability as well as measure effect sizes of the program vs. treatment as usual, and (3) preliminarily test mechanisms of action. The knowledge gained will set the stage for a number of future studies related to further elucidating the mechanisms of mindfulness, and the clinical efficacy and utility of this type of training delivered via digital therapeutics in general. Specifically, this study will provide necessary variances for powering larger phase 2 studies.

Public Health Relevance Statement:
Project Narrative Statement Mindfulness training may help people manage anxiety, but the effects of delivering mindfulness training through a digital platform (app-based digital therapeutics) has yet to be studied. The proposed study will test a mobile mindfulness training program for generalized anxiety disorder. to help individuals decrease worry.

Project Terms:
Address; Adult; Affect; Affective; Aftercare; American; Anger; Anxiety; Anxiety Disorders; anxiety management; anxiety symptoms; anxiety treatment; anxious; Arousal; Aversive Stimulus; Awareness; base; Behavior; Biological Assay; clinical efficacy; Clinical Trials; Cognitive; Conscious; Data; design; digital; Disease; distraction; efficacy study; Emotional; Emotions; Esthesia; experience; Feedback; Feeling; Fright; Future; Generalized Anxiety Disorder; Grief reaction; Habits; Impairment; improved; Individual; innovation; interest; Knowledge; Lead; Learning; Learning Disorders; Measures; Mental disorders; mindfulness; Mindfulness Training; novel; Participant; Pattern; phase 1 study; phase 2 study; Phase II Clinical Trials; Physiological; Population; primary care setting; primary outcome; Process; Program Acceptability; programs; promoter; psychologic; Psychological reinforcement; Public Health; Questionnaires; Randomized; Sleep; social; Standardization; Stimulus; success; Target Populations; Testing; theories; Therapeutic; Thinking; Time; Training; Training Programs; treatment as usual; Treatment Efficacy; Unconscious State; United States; usability; Work

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
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