Investigating How the Brain Processes Different Experiences

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Advancing Our Understanding and Treatment of Anxiety Through Bringing Together Facets of Conscious Experience and Brain Mechanisms: Open/Closed Meets the Default Mode Network

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: App-Delivered Mindfulness Training (MT)
* Behavioral: App-Delivered Coloring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 65 years Able to travel to Brown University for research assessment Able to speak English because all study activities will be conducted in English. GAD-7 ≥ 10 Owns a smartphone Exclusion Criteria: If using psychotropic medication - not on a stable dosage at least 6 weeks As needed (i.e., prn) benzodiazepine use Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis) MRI contraindications Claustrophobia Recreational drug use past 2 weeks Alcohol abuse Pregnancy or plans to become pregnant Cohabiting with a study participant Weight ≥ 300 lbs (due to inability to fit in scanner)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-Delivered Mindfulness Training (MT)<br>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. | Behavioral: App-Delivered Mindfulness Training (MT)<br>* 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.<br>|
| Active Comparator: App-Delivered Coloring<br>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. | Behavioral: App-Delivered Coloring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | collected at baseline and 2 month follow up apt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | collected at baseline and 2 month follow up apt | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Mindfulness, MRI, Cell Phone