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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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).

Contacts and Locations

Locations

United States, Rhode Island

Brown University

Providence, Rhode Island, United States, 02912

Sponsors and Collaborators

MindSciences, Inc.

Brown University

Investigators

• Principal Investigator: Judson Brewer; Brown University

  Study Documents (Full-Text)

Documents provided by Judson Brewer, Brown University:

Informed Consent Form  [PDF] May 2, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: May 18, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Anxiety Disorders; Mental Disorders