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

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

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Unwinding Anxiety Phone App

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
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UA Program engagement	Number of modules completed	Two months
Change in worry	Penn State Worry Questionnaire (PSWQ)	Baseline, two months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety	Generalized Anxiety Disorder - 7 items (GAD-7)	Baseline, two months
Change in self-regulation	Multidimensional Assessment of Interoceptive Awareness (MAIA)	Baseline, two months

Collaborators and Investigators

• Sponsor: MindSciences, Inc.
• Collaborators: Brown University
• Investigators: Principal Investigator: Judson Brewer, Brown University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): October 17, 2019
• Study Completion (Actual): October 17, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Anxiety, worry, mindfulness, meditation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1R41MH118130-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No