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

• ClinicalTrials.gov Identifier: NCT03683472
• Recruitment Status: Completed
• First Posted: September 25, 2018
• Last Update Posted: May 18, 2020
• Sponsor: MindSciences, Inc.
• Collaborator: Brown University
• Information provided by (Responsible Party): Judson Brewer, Brown University

Tracking Information

• First Submitted Date: June 11, 2018
• First Posted Date: September 25, 2018
• Last Update Posted Date: May 18, 2020
• Actual Study Start Date: May 20, 2019
• Actual Primary Completion Date: October 17, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 19, 2019)

• UA Program engagement [ Time Frame: Two months ]
  Number of modules completed
• Change in worry [ Time Frame: Baseline, two months ]
  Penn State Worry Questionnaire (PSWQ)

Original Primary Outcome Measures (submitted: September 21, 2018)

UA Program engagement [ Time Frame: Two months ]

Number of modules completed

Current Secondary Outcome Measures (submitted: June 19, 2019)

• Change in non-reactivity & awareness [ Time Frame: Baseline, two months ]
  Five Facet Mindfulness Questionnaire - Non-Reactivity subscale (FFMQ)
• UA Program Acceptability [ Time Frame: Two months ]
  Net Promoter Score (NPS)

Original Secondary Outcome Measures (submitted: September 21, 2018)

• UA Program Acceptability [ Time Frame: Two months ]
  Net promoter score
• Penn State Worry Questionnaire [ Time Frame: Baseline, one month, two month ]
  Worry
• Five Facet Mindfulness Scale [ Time Frame: Baseline, one month, two month ]
  Non-Reactivity Awareness subscale
• Self Regulation [ Time Frame: Baseline, one month, two month ]
  Multidimensional Assessment of Interoceptive Awareness

Current Other Pre-specified Outcome Measures (submitted: June 19, 2019)

• Change in anxiety [ Time Frame: Baseline, two months ]
  Generalized Anxiety Disorder - 7 items (GAD-7)
• Change in self-regulation [ Time Frame: Baseline, two months ]
  Multidimensional Assessment of Interoceptive Awareness (MAIA)

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
• Official Title: Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Anxiety Disorders

Intervention

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

Study Arms

• 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.
  Intervention: Behavioral: Unwinding Anxiety Phone App

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 6, 2019): 65
• Original Estimated Enrollment (submitted: September 21, 2018): 46
• Actual Study Completion Date: October 17, 2019
• Actual Primary Completion Date: October 17, 2019 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03683472
• Other Study ID Numbers: 1R41MH118130-01( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Judson Brewer, Brown University
• Original Responsible Party: Same as current
• Current Study Sponsor: MindSciences, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Brown University

Investigators

• Principal Investigator: Judson Brewer; Brown University

• PRS Account: MindSciences, Inc.
• Verification Date: May 2020