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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: App-Delivered Mindfulness Training (MT); Behavioral: App-Delivered Coloring

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

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Casamassima, MA; Phone Number: (401) 484-1087; Email: joseph_casamassima@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown University
      • Contact: Joseph Casamassima, MA; Phone Number: 401-484-1087; Email: joseph_casamassima@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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.
Active Comparator: 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.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Dartmouth College; Tiny Blue Dot Foundation
• Investigators: Principal Investigator: Judson Brewer, MD, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Anxiety; Mindfulness; Cell Phone
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022003264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No