Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- MindSciences, Inc.
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Change in worry
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.
Detailed Description
The study 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.
Investigators
Judson Brewer
Director of Research & Innovation
Brown University
Eligibility Criteria
Inclusion Criteria
- •Owns a smart phone
- •GAD - 7 is equal to or greater than 10
Exclusion Criteria
- •If using psychotropic medication - not on a stable dosage for at least 6 weeks
- •Medical disorder of the severity that would interfere with ability to participate
- •Not being fluent in English (due to instructions provided in English)
- •As needed use (i.e. prn) of benzodiazepines
- •Psychotic disorder,
- •Previous MT (e.g. MBSR, other Claritas MindSciences training programs).
Outcomes
Primary Outcomes
Change in worry
Time Frame: Baseline, two months
Penn State Worry Questionnaire (PSWQ)
UA Program engagement
Time Frame: Two months
Number of modules completed
Secondary Outcomes
- UA Program Acceptability(Two months)
- Change in non-reactivity & awareness(Baseline, two months)