SMILE: Clinical Trial to Evaluate Mindfulness as Intervention for Racial and Ethnic Populations During COVID-19

Publication date: Feb 05, 2024

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 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.

Concepts Keywords
Autism App
Biweekly Assessment
Chapel Baseline
Hispanic Complete
Psychometrics Covid


Type Source Name
disease IDO intervention
disease MESH COVID-19
disease VO effectiveness
disease VO report
disease IDO quality
disease VO frequency
disease VO time
disease VO device
disease MESH physiological stress
disease VO biweekly
disease IDO history
disease MESH heart disease
disease MESH stroke
disease MESH dementia
disease MESH movement disorders
disease MESH Parkinson’s Disease
disease MESH genetic disorders
disease MESH Down Syndrome
disease MESH syndrome
disease MESH autism
disease MESH schizophrenia
disease MESH psychosis
disease MESH dissociative disorder
disease MESH mania
disease MESH bipolar disorder
disease MESH personality disorder
disease IDO blood
disease MESH seizure

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