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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively an app-based program can reduce anxiety and explore changes in brain activity. Participants will use either a mindfulness training app or an app-based coloring book. The mindfulness app includes daily activities and exercises to interrupt worry cycles, while the coloring app helps relax and lower stress. The trial seeks individuals with moderate to severe anxiety who own a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new anxiety management tools.

Will I have to stop taking my current medications?

If you're on psychotropic medication, you need to be on a stable dosage for at least 6 weeks before joining the trial. If you use benzodiazepines as needed, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, a self-guided mindfulness program delivered through a mobile app proved practical and well-received by ICU survivors. Other research has shown that mindfulness apps, such as Headspace, can improve focus, enhance sleep quality, and reduce stress. Evidence also suggests that using a smartphone app for mindfulness exercises can lessen symptoms of depression and anxiety. Another study found the Headspace app effective in reducing stress and anxiety during pregnancy. Overall, app-based mindfulness training appears well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for anxiety because they offer innovative ways to tackle stress using technology. The app-delivered mindfulness training is unique because it provides a structured, interactive experience through daily modules with videos and animations, helping to break worry cycles right in the moment. Unlike many traditional therapies that require in-person sessions, this method leverages smartphone technology, making mindfulness practice more accessible and engaging. Meanwhile, the app-delivered coloring offers a relaxing alternative by providing a digital coloring book designed to reduce anxiety, drawing on the calming effects of art therapy. Both approaches aim to empower users to manage anxiety conveniently, anytime and anywhere.

What evidence suggests that this trial's treatments could be effective for anxiety?

Research has shown that mindfulness apps can help reduce anxiety. In this trial, participants will join one of two app-based interventions. One group will use the App-Delivered Mindfulness Training (MT), which progresses through over 30 daily modules of mindfulness training. Another group will use the App-Delivered Coloring, an app-based coloring book designed to promote relaxation and reduce stress. One study found that using a smartphone app for mindfulness exercises eased symptoms of depression and anxiety. Another review showed small improvements in anxiety when using mindfulness apps compared to not using them. While effects can vary, some users report feeling less stressed after using these apps. Overall, mindfulness training through apps offers a promising way to manage anxiety. ^{3 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8825782/

Effects of Mindfulness Exercise Guided by a Smartphone ... The findings indicate the potentially beneficial effect of mindfulness exercise guided by a smartphone app on symptoms of depression and anxiety.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0272735823001289

Review The efficacy of mindfulness apps on symptoms ... Mindfulness apps led to small improvements in depression and anxiety relative to controls. •. Mindfulness was not significantly different to active therapeutic ...

3. nature.com nature.com/articles/s44184-023-00048-5

The impact of mindfulness apps on psychological ... Recent reviews suggest that mindfulness app effects on clinical outcomes are often inconsistent. For example, one review found generally small ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6614998/

Efficacy of the Mindfulness Meditation Mobile App “Calm” ... Calm is an effective modality to deliver mindfulness meditation in order to reduce stress and improve mindfulness and self-compassion in stressed college ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0209482

The efficacy of a brief app-based mindfulness intervention on ... This pilot randomised controlled trial shows that self-reported improvements in psychosocial outcomes can be achieved at low cost through short-term engagement.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6460929/

Effects of mindfulness training programs delivered by a self ... A self-directed, four-session post-discharge mindfulness program for ICU survivors delivered by a mobile app was feasible, acceptable, usable, and demonstrated ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10986332/

The Real-World Impact of App-Based Mindfulness on ... Previous clinical trials on the efficacy of the Headspace app show evidence of improved mindfulness, focus, stress, sleep quality, burnout, ...

8. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2021.773296/full

Effects of Mindfulness Exercise Guided by a Smartphone ... The findings indicate the potentially beneficial effect of mindfulness exercise guided by a smartphone app on symptoms of depression and anxiety.

9. pediatrics.jmir.org pediatrics.jmir.org/2023/1/e53933/

Evaluating the Impact of an App-Delivered Mindfulness ... This study found evidence to support the Headspace app as an effective intervention to aid in stress and anxiety reduction during pregnancy.