TerminatedNANCT06242080

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

Sponsor: University of North Carolina, Chapel Hill

Trial Details

ConditionAnxiety, COVID-19 Pandemic
InterventionMindfulness
PhaseNA
StatusTerminated
Participants398
Est. Completion27 May 2025
Last Updated14 May 2026

Primary Outcome

Change From Baseline to Post-Intervention in the Generalized Anxiety Disorder-7 Scale; Change From Baseline to Follow-up in the Generalized Anxiety Disorder-7 Scale

Eligibility Criteria

Inclusion 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

Trial Sites

Countries

United States
View Registry Entry

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