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Behavioral Intervention

Mindfulness Training for Anxiety

N/A

Waitlist Available

Led By Judson Brewer, MD, PhD

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 - 65 years

Be older than 18 years old

Must not have

Weight ≥ 300 lbs (due to inability to fit in scanner)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at baseline and 2 month follow up apt

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if an app can reduce anxiety and study how it affects the brain.

Who is the study for?

This trial is for adults aged 18-65 who experience anxiety, can speak English, and are able to visit Brown University for assessments. Participants must own a smartphone and score at least 10 on the GAD-7 anxiety scale. Those using drugs recently, with unstable psychotropic medication doses, pregnant or planning pregnancy, living with another participant, over 300 lbs., using benzodiazepines as needed, or having certain mental health conditions cannot join.

What is being tested?

The study tests an app-based mindfulness training (MT) program against an app-delivered coloring activity to see which better reduces anxiety symptoms. It also looks at how these activities affect brain function by observing changes in brain activity.

What are the potential side effects?

Since this trial involves non-invasive app-based interventions like mindfulness training and coloring activities, significant side effects are not expected. However, participants may experience discomfort from sitting still during brain scans or mild frustration if they find the apps difficult to use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I weigh less than 300 lbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at baseline and 2 month follow up apt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at baseline and 2 month follow up apt

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at baseline and 2 month follow up apt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Posterior Cingulate Cortex (PCC) Blood Oxygen Level Dependent (BOLD) Signal

Change in GAD - 7

Secondary study objectives

Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale

Penn State Worry Questionnaire (PSWQ)

Other study objectives

Acceptance & Action questionnaire (AAQ-II)

Anxiety Sensitivity Index (ASI)

Interest (I) Type and Deprivation (D) Type scale (I/D)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: App-Delivered Mindfulness Training (MT)Experimental Treatment1 Intervention

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.

Group II: App-Delivered ColoringActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

App-Delivered Mindfulness Training (MT)

2019

N/A

~100

0 / 2Eligibility criteria met