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

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Unwinding Anxiety Phone App

• Registration Number: NCT03683472
• Lead Sponsor: MindSciences, Inc.

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 Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Study Start: 2019-05-20
• Primary Completion: 2019-10-17
• Study Completion: 2019-10-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU and Unwinding Anxiety Phone App	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.

Primary Outcome Measures

Name	Time	Method
Change in worry	Baseline, two months	Penn State Worry Questionnaire (PSWQ)
UA Program engagement	Two months	Number of modules completed

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States