The goal of this clinical trial is to test the efficacy of an app-based program in reducing anxiety and exploring associated changes in brain activity.
The main question\[s\] it aims to answer are: PRIMARY AIM: Confirm that the conscious experience of open/closed correlates with P/PCC activation/deactivation. SECONDARY AIM: Determine if changes in P/PCC activity predict clinical outcomes (GAD-7 scores) in individuals with moderate to severe anxiety after using an app. Participants may be asked to: * Complete a Zoom interview * Complete online surveys at baseline and 2 months post-treatment initiation * Complete MRIs at baseline and 2 months post-treatment initiation * Wear a smartwatch and answer daily questions about their anxiety * Use an app daily
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
125
The program is delivered via a smartphone-based platform, which includes a progression through 30+ daily modules of brief didactic and experience-based mindfulness training (videos and animations), app-triggered check-ins to encourage engagement, and user-initiated guided mindfulness exercises to help disrupt worry cycles in the moment.
An app-based coloring book with a variety of designs to choose from including mandalas, animal patterns, and florals. It is designed to help individuals relax and reduce stress and anxiety based on the benefits found in past research studies.
Brown University
Providence, Rhode Island, United States
Change in GAD - 7
Generalized Anxiety Disorder 7-items (GAD-7). The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).
Time frame: collected at baseline and 2 month follow up apt
Change From Baseline in Posterior Cingulate Cortex (PCC) Blood Oxygen Level Dependent (BOLD) Signal
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
Time frame: collected at baseline and 2 month follow up apt
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a validated 16-item self-report measure of worry with items presented on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me).
Time frame: collected at baseline and 2 month follow up apt
Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale
The non-reactivity scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 7 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).
Time frame: collected at baseline and 2 month follow up apt
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