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

NCT06242080 | Terminated

• 2 other identifiers: 23-01545R01MD017051
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; COVID-19 Pandemic

Keywords

Digital Health Platform; Heart Rate Variability; Mindfulness; Cultural/ethnic health disparities

Outcome Measures

Primary Outcomes (2)

• Change from Baseline to Post-Intervention in the Generalized Anxiety Disorder-7 scale

  Generalized Anxiety Disorder scale (GAD-7) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior 2 weeks. Response categories range from 0 ("Not at all") to 3 ("Nearly every day"). Scores are summed leading to a range of 0-21. Higher scores indicate greater anxiety symptoms. Among-group differences in the change scores are measured with a mixed effects model controlling for gender, ethnicity, and age as well as data dependencies (MTIA cohort number). Treatment-by-time differences will be assessed using an omnibus test (F-test) with a null hypothesis that there is no treatment-by- time effect among the three treatment arms. If the difference of treatment effect is significant at the 0.05 level, the investigators will then examine individual group contrasts with the control group as the reference category.

  Baseline, 8 week

• Change from Baseline to Follow-up in the Generalized Anxiety Disorder-7 scale

  Generalized Anxiety Disorder scale (GAD-7) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior 2 weeks. Response categories range from 0 ("Not at all") to 3 ("Nearly every day"). Scores are summed leading to a range of 0-21. Higher scores indicate greater anxiety symptoms. Among-group differences in the change scores are measured with a mixed effects model controlling for gender, ethnicity, and age as well as data dependencies (MTIA cohort number). Treatment-by-time differences will be assessed using an omnibus test (F-test) with a null hypothesis that there is no treatment-by- time effect among the three treatment arms. If the difference of treatment effect is significant at the 0.05 level, the investigators will then examine individual group contrasts with the control group as the reference category.

  Baseline, 12 weeks

Secondary Outcomes (35)

• Change in Autonomic activity from Baseline to Post-Intervention as measured by heart period

  Baseline, 8 weeks

• Change in Autonomic activity from Baseline to Follow-up as measured by heart period

  Baseline, 12 weeks

• Change in Parasympathetic activity Baseline to Post-Intervention as measured by high-frequency heart rate variability (HF-HRV)

  Baseline, 8 weeks

• Change in Parasympathetic activity Baseline to Follow-up as measured by high-frequency heart rate variability (HF-HRV)

  Baseline, 12 weeks

• Change in Vagal efficiency Baseline to Post-intervention measured using HF-HRV and heart period coupling

  Baseline, 8 weeks

Study Arms (3)

"MTIA" intervention

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness

"MAPP" intervention

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness

Wait-list Control

NO INTERVENTION

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.

Interventions

Mindfulness 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; "MTIA" intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• RTI International: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7160, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; COVID-19

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susan Gaylord, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Maria Davila, PhD

  Research Triangle Institute (RTI)

  PRINCIPAL INVESTIGATOR

• Keri J Heilman, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The research statistician will randomize the participants into one of the intervention groups as soon as at least 24-30 (8-10 individuals per group) are consented. Randomization by group will be implemented using a modified miniRand procedure implemented in R software. Randomization will be stratified by ethnicity (Hispanic/Latino vs Black/African-American) to approximate equal representation in each arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 parallel arms (MTIA intervention, MAPP intervention, wait-list control group)

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 5, 2024
• Study Start: May 13, 2024
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: For data belonging to UNC (Mindfulness program usage, participant satisfaction), users must have approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC. For data belonging to RTI (demographics, cardiac data, psychological/behavioral questionnaires collected using the SMILE app), users must execute a data use/sharing agreement with RTI.

Locations

US (1)