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

MindSciences

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: Unwinding Anxiety Phone App

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03683472

1R41MH118130-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Treatment as usual (TAU)

No Intervention group

Description:

Individuals will receive treatment as usual

TAU and Unwinding Anxiety Phone App

Active Comparator group

Description:

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.

Treatment:

Behavioral: Unwinding Anxiety Phone App