Advancing Our Understanding and Treatment of Anxiety Through Bringing Together Facets of Conscious Experience and Brain Mechanisms: Open/Closed Meets the Default Mode Network
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- Brown University
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Change in GAD - 7
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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.
- •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)
Outcomes
Primary Outcomes
Change in GAD - 7
Time Frame: collected at baseline and 2 month follow up apt
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).
Change From Baseline in Posterior Cingulate Cortex (PCC) Blood Oxygen Level Dependent (BOLD) Signal
Time Frame: collected at baseline and 2 month follow up apt
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
Secondary Outcomes
- Penn State Worry Questionnaire (PSWQ)(collected at baseline and 2 month follow up apt)
- Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale(collected at baseline and 2 month follow up apt)