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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683472
• Other study ID #: 1R41MH118130-01
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: October 17, 2019

Study information

• Verified date: May 2020
• Source: MindSciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
MindSciences, Inc.	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in anxiety	Generalized Anxiety Disorder - 7 items (GAD-7)	Baseline, two months
Other	Change in self-regulation	Multidimensional Assessment of Interoceptive Awareness (MAIA)	Baseline, two months
Primary	UA Program engagement	Number of modules completed	Two months
Primary	Change in worry	Penn State Worry Questionnaire (PSWQ)	Baseline, two months
Secondary	Change in non-reactivity & awareness	Five Facet Mindfulness Questionnaire - Non-Reactivity subscale (FFMQ)	Baseline, two months
Secondary	UA Program Acceptability	Net Promoter Score (NPS)	Two months