Mindfulness for Anxiety

(RED Trial)

Overseen By Yara Mekawi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

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

Compensation: Varies

Number of Visits: 2

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how race-related stress affects attention and how mindfulness can help. Participants will engage in various combinations of mindfulness activities or control audio sessions to determine the most effective approach. The trial seeks Black or African American individuals who have experienced or witnessed racism and are willing to spend 1.5 hours at the University of Louisville within the next two weeks.

As an unphased study, this trial offers a unique opportunity to contribute to understanding the impact of mindfulness on race-related stress.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this Stress and Mindfulness Intervention is safe?

Research has shown that mindfulness activities are generally safe for people. Studies have found that these activities help lower stress and anxiety without serious side effects. In one review, most participants found mindfulness practices easy to handle, with only a few reporting negative experiences. Another study showed that a short mindfulness program effectively reduced stress in healthcare workers without causing harm. Overall, mindfulness is considered a safe treatment that can improve mental well-being for many people. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about the Stress and Mindfulness Intervention for anxiety because it offers a holistic approach that combines mental exercises with relaxation techniques, which is different from traditional treatments like medication or cognitive behavioral therapy. This intervention focuses on reducing stress and improving mindfulness, helping participants manage their anxiety through awareness and acceptance of their thoughts and feelings. Unlike standard treatments, which often involve pharmaceuticals, this approach encourages self-regulation and empowerment, potentially reducing side effects and improving long-term mental health.

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

Research has shown that mindfulness activities can greatly reduce anxiety symptoms. A review of over 200 studies found that mindfulness therapy effectively lowers stress and anxiety. This trial will randomize participants into different groups, including those receiving a stress and mindfulness intervention. In other studies, participants reported feeling less anxious and having better control over their emotions after mindfulness training. These activities also help individuals become more self-aware and manage stress more effectively. Overall, mindfulness has a strong history of helping with anxiety and related issues. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This study is for Black or African American individuals who have experienced racism or racial microaggressions, are willing to participate in a 1.5-hour study at the University of Louisville within two weeks, and are aged 18 or older.

Inclusion Criteria

Eligibility for this study will include a positive response to the following questions: 1) Do you identify as Black or African American? 2) Have you ever in your lifetime personally experienced or witnessed another person experience any acts of racism or racial microaggressions? 3) Are you willing to complete a 1.5-hour study at the University of Louisville in the next 2 weeks? 4) Are you 18 or older?

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Manipulation

Participants undergo race-related stress manipulation and mindfulness intervention or control conditions

1 session

1 visit (in-person)

Assessment

Participants complete the Free Viewing Task and PANAS to assess attention bias to threat and affect

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any changes in psychological symptoms post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stress and Mindfulness Intervention

Trial Overview The RED Study aims to explore how race-related stress affects attention and to evaluate the effectiveness of interventions focused on stress and mindfulness in addressing these impacts.

How Is the Trial Designed?

Group I: Main sample Experimental Treatment 1 Intervention

Participants are randomized to experimental and intervention conditions. They are either in: race stress/mindfulness, race stress/control audio, control stress/mindfulness, or control stress/control audio.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11086195/

Effectiveness of mindfulness-based interventions on the well ... MBIs such as stress reduction programmes, apps, meditation and training showed small to large effects on anxiety, burnout, stress, depression, psychological ...

2. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1347336/full

Exploring the sustained impact of the Mindfulness-Based ... These improvements included reduced symptoms of anxiety and depression, increased self-awareness, and improved emotional regulation.

3. nature.com nature.com/articles/s41598-024-64183-5

A mindfulness-based intervention improves perceived ... MBIs have been shown to effectively address a wide range of conditions and outcomes, including anxiety, depression, stress, disordered eating, ...

4. apa.org apa.org/topics/mindfulness/meditation

Mindfulness meditation: A research-proven way to reduce ... Researchers reviewed more than 200 studies of mindfulness among healthy people and found mindfulness-based therapy was especially effective for reducing stress ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2769761

Effect of a Brief Mindfulness-Based Program on Stress in ... Our intervention was also effective in reducing anxiety among participants. Reduction in both stress and anxiety was maintained at follow-up ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8083197/

Mindfulness-based interventions: an overall review - PMC The effects of mindfulness-based stress reduction on depression, anxiety, and stress in older adults: a systematic review and meta-analysis.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5679245/

Mindfulness-Based Interventions for Anxiety and Depression These outcomes include clinical disorders and symptoms such as anxiety, risk of relapse for depression, current depressive symptoms, stress, medical and well- ...