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Sponsor: University of North Carolina, Chapel Hill
Conditions: Anxiety, COVID-19 Pandemic
Interventions: Mindfulness
Countries: United States
The goal of this clinical trial is to evaluate the SMILE app, a Digital Health Platform (DHP), that will deliver a mindfulness intervention, designed to mitigate COVID-19 related stress. Additionally, the SMILE app will remotely collect self-reported psychological and physiological metrics of mental health and autonomic regulation. Study participants are adults who self-identify as African American, Black and/or Latino, and who have clinically significant levels of anxiety. The study aims are: * Aim 1: Establish the effectiveness and durability of an 8-week Mindfulness DHP intervention. The investigators will focus on two constructs important to mental health and hypothesize that: A) Anxiety, self-report stress and quality-of-life measures will significantly improve when comparing: A.1) Pre-to-post intervention, and; A.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. B) Arousal, autonomic indices of HRV (reflecting parasympathetic activation) will significantly improve, when comparing: B.1) Pre-to-post intervention, and; B.2) Control vs. intervention groups over 8 weeks and at 1-month follow-up. * Aim 2: Establish the sustainability of two Mindfulness DHP interventions utilizing retention, usage (frequency), and participant satisfaction. * Aim 3: Examine associations between COVID-19 related stress, mental health outcomes, and HRV. Examine the extent to which COVID-19 related stress and mental health symptoms are linked to HRV at baseline and how that relationship changes over time. Participants will be assigned to 1 of 3 arms of the study: MTIA intervention, MAPP intervention, or wait-list control. All participants will be mailed a device with the SMILE app installed, and the equipment for recording cardiac data in the home. All participants will complete the baseline psychometrics measures and physiological stress test using the instructions provided on the SMILE app. Those assigned to the MTIA or MAPP intervention groups will then participate in their assigned intervention over the subsequent 8 weeks. During these 8 weeks, psychometric and physiological data will be completed biweekly for all participants. 3 months following the initial baseline, all participants will complete a final psychometric/physiological evaluation.
Sex: ALL
Age: 18 Years to 99 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Chapel Hill, North Carolina, United States