Mindfulness Training for Anxiety

Overseen By Joseph Casamassima, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Must not be taking: Psychotropics, Benzodiazepines

Disqualifiers: Psychotic disorders, Drug use, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Judson Brewer, MD, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Owns a smartphone

GAD-7 ≥ 10

Able to travel to Brown University for research assessment

Exclusion Criteria

You are afraid of being in small or confined spaces.

I weigh less than 300 lbs.

I have not been on a stable dose of my mental health medication for 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in app-based mindfulness training or coloring activities for anxiety reduction

8 weeks

Daily app usage, 1 Zoom interview, 2 MRI visits

Follow-up

Participants are monitored for changes in anxiety and brain activity post-treatment

4 weeks

Online surveys and MRI at 2 months post-treatment initiation

What Are the Treatments Tested in This Trial?

Interventions

• App-Delivered Coloring
• App-Delivered Mindfulness Training (MT)

Trial Overview 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.

How Is the Trial Designed?

Group I: App-Delivered Mindfulness Training (MT) Experimental Treatment 1 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 Coloring Active Control 1 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.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Tiny Blue Dot Foundation

Collaborator

Trials

10

Recruited

660+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Tiny Blue Dot Foundation

Collaborator

Trials

9

Recruited

640+