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OpenTrials
Completed

NCT Number: NCT03683472

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.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Unwinding Anxiety Phone App

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

MindSciences, Inc.

Industry

Collaborators

  • Brown University

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2018
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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