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

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

Detailed Description
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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.

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Unwinding Anxiety Phone App


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual (TAU)<br>Individuals will receive treatment as usual | |
| Active Comparator: TAU and Unwinding Anxiety Phone App<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, worry, mindfulness, meditation