NCT06051084

Investigating How the Brain Processes Different Experiences

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	App-Delivered Mindfulness Training (MT)	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 Coloring	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.

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-01-31
• Completion: 2025-03-31
• First posted: 2023-09-22
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States