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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683472
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Judson Brewer, Brown University

Brief Summary:
The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Unwinding Anxiety Phone App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : October 17, 2019
Actual Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Treatment as usual (TAU)
Individuals will receive treatment as usual
Active Comparator: 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.
Behavioral: 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




Primary Outcome Measures :
  1. UA Program engagement [ Time Frame: Two months ]
    Number of modules completed

  2. Change in worry [ Time Frame: Baseline, two months ]
    Penn State Worry Questionnaire (PSWQ)


Secondary Outcome Measures :
  1. Change in non-reactivity & awareness [ Time Frame: Baseline, two months ]
    Five Facet Mindfulness Questionnaire - Non-Reactivity subscale (FFMQ)

  2. UA Program Acceptability [ Time Frame: Two months ]
    Net Promoter Score (NPS)


Other Outcome Measures:
  1. Change in anxiety [ Time Frame: Baseline, two months ]
    Generalized Anxiety Disorder - 7 items (GAD-7)

  2. Change in self-regulation [ Time Frame: Baseline, two months ]
    Multidimensional Assessment of Interoceptive Awareness (MAIA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683472


Locations
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United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
MindSciences, Inc.
Brown University
Investigators
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Principal Investigator: Judson Brewer Brown University
  Study Documents (Full-Text)

Documents provided by Judson Brewer, Brown University:
Informed Consent Form  [PDF] May 2, 2019

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Responsible Party: Judson Brewer, Director of Research & Innovation, Brown University
ClinicalTrials.gov Identifier: NCT03683472    
Other Study ID Numbers: 1R41MH118130-01 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judson Brewer, Brown University:
Anxiety, worry, mindfulness, meditation
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders