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

NCT ID: NCT06242080

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2025-05-27

Brief Summary

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.

Detailed Description

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.

Conditions

Anxiety; COVID-19 Pandemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

"MTIA" intervention

The Mindfulness Training Instructor Administered ("MTIA") intervention will incorporate the following elements: training in an 8-week, 90-minute per week, modified mindfulness program, which places additional emphasis on training which is feasible and relevant to race/ethnic groups, including: a) didactics on relevance to stress, coping and resilience, b) mindful compassion for self and others; c) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking. 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.

Group Type: ACTIVE_COMPARATOR

Mindfulness

Intervention Type: BEHAVIORAL

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.

"MAPP" intervention

The MindfulnessAPP ("MAPP") is a self-administered intervention developed by the SMILE study team. The MAPP is for individual use, with eight MAPP sessions composed of mindfulness exercises and didactics that correspond to the MTIA sessions. As the MTIA weekly class will be 90 minutes in length, the MAPP assignments will recommend spending approximately 90 minutes per week covering the assigned lesson, but in a flexible format convenient for the participant. In addition, each session will contain mindfulness-based practice assignments generally ranging from 10 to 30 minutes per day. The total number of suggested days for completion will be 49 days, comparable to the time from start to finish of a traditional 8 week MTIA session; however, there will be flexibility within this individualized program.

Group Type: ACTIVE_COMPARATOR

Mindfulness

Intervention Type: BEHAVIORAL

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.

Wait-list Control

The Wait-list Control (WLC) group will participate in all research assessment sessions, but will not be offered the Mindfulness intervention until after their role in the research is complete.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Gaylord, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Maria Davila, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Triangle Institute (RTI)

Keri J Heilman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01MD017051

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0154

Identifier Type: -

Identifier Source: org_study_id