Investigating How the Brain Processes Different Experiences

Brown University

Status: Invitation-only

Conditions: Anxiety

Treatments: Behavioral: App-Delivered Coloring; Behavioral: App-Delivered Mindfulness Training (MT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06051084

2022003264

Details and patient eligibility

About

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.

Full 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

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 - 65 years
2. Able to travel to Brown University for research assessment
3. Able to speak English because all study activities will be conducted in English.
4. GAD-7 ≥ 10
5. Owns a smartphone

Exclusion criteria

1. If using psychotropic medication - not on a stable dosage at least 6 weeks
2. As needed (i.e., prn) benzodiazepine use
3. Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
4. MRI contraindications
5. Claustrophobia
6. Recreational drug use past 2 weeks
7. Alcohol abuse
8. Pregnancy or plans to become pregnant
9. Cohabiting with a study participant
10. Weight ≥ 300 lbs (due to inability to fit in scanner)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 2 patient groups

App-Delivered Mindfulness Training (MT)

Experimental group

Description:

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.

Treatment:

Behavioral: App-Delivered Mindfulness Training (MT)

App-Delivered Coloring

Active Comparator group

Description:

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.

Treatment:

Behavioral: App-Delivered Coloring