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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| Tiny Blue Dot Foundation | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-Delivered Mindfulness Training (MT) | Experimental | 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. |
|
| App-Delivered Coloring | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-Delivered Mindfulness Training (MT) | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Multidimensional Assessment of Interoceptive Awareness (MAIA) | The MAIA is a validated 32-item self-report questionnaire comprised of 8 subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Items are rated on a 6-point Likert scale ranging from 0 (never) to 5 (always). | collected at baseline and 2 month follow up apt |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judson Brewer, MD, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02903 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
| App-Delivered Coloring | Behavioral | 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. |
|
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 |
| Anxiety Sensitivity Index (ASI) | The ASI is a validated 16-item self-report measure of the fear of anxiety sensations. Items are rated on a 5-point Likert scale ranging from 0 (Very little) to 4 (Very much). | collected at baseline and 2 month follow up apt |
| Interest (I) Type and Deprivation (D) Type scale (I/D) | The I/D scale is a validated 10-item self-report measure of curiosity. Items are rated on a 4-point Likert scale ranging from 1 (Almost never) to 4 (Almost always). | collected at baseline and 2 month follow up apt |
| Acceptance & Action questionnaire (AAQ-II) | The AAQ-II is a validated 7-item self-report measure of experiential avoidance. Items are rated on a 7-point Likert scale ranging from 1 (Never true) to 7 (Always true). | collected at baseline and 2 month follow up apt |
| Intolerance of Uncertainty 12-item scale (IUS-12) | The IUS-12 is a validated 12-item self-report measure of intolerance of uncertainty. Items are rated on a 5-point Likert scale ranging from 1 (Not at all characteristic of me) to 5 (Entirely characteristic of me). | collected at baseline and 2 month follow up apt |