Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
NCT ID: NCT03683472
Last Updated: 2020-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2019-05-20
2019-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment as usual (TAU)
Individuals will receive treatment as usual
No interventions assigned to this group
TAU and Unwinding Anxiety Phone App
The Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety. Together, these help individuals "unlearn"/extinguish worry at a core mechanistic level.
Unwinding Anxiety Phone App
The Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety
Interventions
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Unwinding Anxiety Phone App
The Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety
Eligibility Criteria
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Inclusion Criteria
* GAD - 7 is equal to or greater than 10
Exclusion Criteria
* 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).
18 Years
ALL
Yes
Sponsors
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Brown University
OTHER
MindSciences, Inc.
INDUSTRY
Responsible Party
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Judson Brewer
Director of Research & Innovation
Principal Investigators
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Judson Brewer
Role: PRINCIPAL_INVESTIGATOR
Brown University
Locations
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Brown University
Providence, Rhode Island, United States
Countries
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References
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Taylor VA, Roy A, Brewer JA. Cluster-based psychological phenotyping and differences in anxiety treatment outcomes. Sci Rep. 2023 Feb 21;13(1):3055. doi: 10.1038/s41598-023-28660-7.
Roy A, Hoge EA, Abrante P, Druker S, Liu T, Brewer JA. Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial. J Med Internet Res. 2021 Dec 2;23(12):e26987. doi: 10.2196/26987.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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