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-19related stress. Additionally, the SMILE app will remotely collect self-reportedpsychological and physiological metrics of mental health and autonomic regulation. Studyparticipants are adults who self-identify as African American, Black and/or Latino, andwho 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, MAPPintervention, or wait-list control. All participants will be mailed a device with theSMILE app installed, and the equipment for recording cardiac data in the home. Allparticipants will complete the baseline psychometrics measures and physiological stresstest using the instructions provided on the SMILE app. Those assigned to the MTIA or MAPPintervention groups will then participate in their assigned intervention over thesubsequent 8 weeks. During these 8 weeks, psychometric and physiological data will becompleted biweekly for all participants. 3 months following the initial baseline, allparticipants will complete a final psychometric/physiological evaluation.
All data collection will occur remotely and intervention sessions will be virtual (i.e.,
in participants' homes). Participants will be provided with a tablet loaded with the
SMILE app and a heart rate monitor and will view, or participate in, a virtual
introductory tutorial on the use of the equipment. All psychological and physiological
data will be collected via the SMILE app. Participants will be assigned to 1 of 3 groups
(MTIA, MAPP, WLC), and all participants will complete each scheduled assessment,
regardless of group assignment.
1. Baseline assessment (week 0). Participants will complete demographic and
psychological questionnaires followed by a HRV assessment protocol, which consists
of asking participants to attach the heart rate monitor and follow the
instructions/model on the app to complete a cognitive stress test and an orthostatic
test.
In addition to the demographic questionnaire, the psychological measures included in
the baseline assessment are: GAD-7, COVID Stress Scale (COVID-SS), Connor-Davidson
Resilience Scale (CD RISC), Mental Health Quality of Life (MHQoL), Coping
Orientation to Problems Experienced Inventory (Brief COPE), Perceived Stress Scale
(PSS), Posttraumatic Growth Inventory (PTGI), sleep disturbance (Adult
Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form), PTSD
Checklist, Center for Epidemiologic Studies Depression Scale (CES-D), Cognitive and
Affective Mindfulness Scale-Revised (CAMS-R), and physical health (Short Form Health
Survey, SF-12).
2. Intervention (weeks 1-8). Participants assigned to the MTIA and MAPP groups will
participate in the 8 week intervention. Both intervention programs are mindful
meditative practices, designed to cultivate regulation of attention to present
moment awareness, as well as develop mindfulness and awareness skills to improve
coping and reduce stress, thereby lowering anxiety and increasing well-being.
The MTIA will be instructor led, internet-delivered (via Zoom), interactive,
group-based mindfulness training intervention that will incorporate the training for
approximately 9 persons in a group format, with outside-of session assignments. The
MindfulnessAPP (MAPP) is a self-administered, internet-delivered intervention
developed by the SMILE study team.
Biweekly during weeks 1-6, participants in all groups will be asked to complete
assessments which include psychological questionnaires (GAD-7, COVID-SS, CD RISC,
CAMS-R) and the same HRV assessment protocol as the baseline. Participants in both
mindfulness groups will be asked to provide documentation of mindfulness practice.
3. 8 week and follow-up assessment at week 12: participants in all groups will be asked
to complete assessments which include psychological questionnaires (GAD-7, COVID-SS,
CD RISC, MHQoL, COPE, PSS, PTGI, PROMIS, PTSD Checklist, CES-D, CAMS-R, and SF-12)
and the same HRV assessment protocol as the baseline.
Behavioral: Mindfulness
Mindfulness meditation has been described as a behavioral technique involving the
intentional self-regulation of attention to present-moment experience, combined with
release of cognitive fixation on thoughts (whether simple images or complex story lines)
regarding the past or future. Through training in mindfulness, individuals learn to evoke
and sustain a non-judgmental state of present-moment awareness.
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
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Investigator: Kim Faurot, PhD
Contact: 919-966-3578
faurot@med.unc.edu
Kim Faurot, PhD
(919) 904-9842
faurot@med.unc.edu