Mindfulness intervention for anxiety in racial and ethnic populations during COVID-19
Digital Health Platform (DHP) to Deliver Mindfulness as a Stress Management Intervention Leveraging Electronic (SMILE) Health Records for Racial and Ethnic Populations During the COVID-19 Pandemic: Clinical Trial
NA · University of North Carolina, Chapel Hill · NCT06242080
This study is testing a mindfulness app to see if it can help reduce anxiety and stress during COVID-19 for adults who are African American, Black, or Latino.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 404 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06242080 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the SMILE app, a digital health platform designed to deliver mindfulness interventions aimed at reducing COVID-19 related stress among adults who identify as African American, Black, or Latino. Participants will engage in an 8-week program that includes virtual sessions and self-reported assessments of psychological and physiological metrics. The study will assess the effectiveness of the intervention by comparing anxiety levels and heart rate variability before and after the program, as well as at a one-month follow-up. All data collection will occur remotely, ensuring accessibility for participants in their own homes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults who self-identify as African American, Black, or Latino and exhibit clinically significant levels of anxiety.
Not a fit: Patients with serious mental health disorders or those currently practicing formal mindfulness for more than 15 minutes a day may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce anxiety and improve quality of life for participants from racial and ethnic minority groups during the ongoing pandemic.
How similar studies have performed: Other studies have shown promise in using mindfulness interventions for anxiety, particularly in diverse populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * self-identify as African American, Black, Hispanic and/or Latino * demonstrate symptoms of anxiety, as determined based on the GAD-7 screening measure (score between 8-14) Exclusion Criteria: * Current, or history of, heart disease * History of stroke or dementia * Diagnosis of movement disorders, such as Parkinson's Disease, or paralysis * Diagnosis of genetic disorders, such as Down Syndrome or Fragile-X syndrome * Diagnosis of autism * Diagnosis of schizophrenia, psychosis, dissociative disorder, mania/bipolar disorder, major depression or a personality disorder * History of serious mental or behavioral health problems requiring a hospital or treatment center stay within the past 12 months * Taking cardiac medications (other than blood pressure medications) * Taking seizure medications * Currently taking opioids medications or supplements * Practice of formal mindfulness for more than 15 minutes/day for 4 or more days/week over the past 6 months * GAD score \<8 or \>14
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Susan Gaylord, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Kim Faurot, PhD
- Email: faurot@med.unc.edu
- Phone: (919) 904-9842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety, COVID-19 Pandemic, Digital Health Platform, Heart Rate Variability, Mindfulness, Cultural/ethnic health disparities