AnxietySMILENCT06242080
SMILE: Clinical Trial to Evaluate Mindfulness as Intervention for Racial and Ethnic Populations During COVID-19
A study testing Mindfulness in people with Anxiety and COVID-19 Pandemic, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anxiety, COVID-19 Pandemic
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2024to 27 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7160
About this study
Official title: Digital Health Platform (DHP) to Deliver Mindfulness as a Stress Management Intervention Leveraging Electronic (SMILE) Health Records for Racial and Ethnic Populations During the COVID-19 Pandemic: Clinical Trial
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:
Read more
- 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.
Read the 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.
- Baseline assessment (week 0). Participants will complete demographic and psychological questionnaires followed by a Heart Rate Variability (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)).
- 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.
- 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
- Being tested
- Mindfulness
- Keywords
- Digital Health Platform, Heart Rate Variability, Mindfulness, Cultural/ethnic health disparities
- Medical subject headings
- Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. The among-group differences in the change scores are compared by ANOVA.
Measured: 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. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 12 weeks
Secondary outcomes (35)
Change in Autonomic Activity From Baseline to Post-Intervention as Measured by Heart Period
Heart period (time in milliseconds between heartbeats) will be measured using the Polar H10 device. Range: 200-1500 msec
Measured: Baseline, 8 weeks
Change in Autonomic Activity From Baseline to Follow-up as Measured by Heart Period
Heart period (time in milliseconds between heartbeats) will be measured using the Polar H10 device. Range: 200-1500 msec
Measured: Baseline, 12 weeks
Change in Parasympathetic Activity Baseline to Post-Intervention as Measured by High-frequency Heart Rate Variability (HF-HRV)
High-frequency heart rate variability will be calculated from heart period data using CardioBatch Plus software. Range: 0 - 15 ln (msec)^2. Greater variability indicates greater parasympathetic activity.
Measured: Baseline, 8 weeks
Change in Parasympathetic Activity Baseline to Follow-up as Measured by High-frequency Heart Rate Variability (HF-HRV)
High-frequency heart rate variability will be calculated from heart period data using CardioBatch Plus software. Range: 0 - 15 ln(msec)^2. Greater variability indicates greater parasympathetic activity.
Measured: Baseline, 12 weeks
Change in Vagal Efficiency Baseline to Post-intervention Measured Using HF-HRV and Heart Period Coupling
Vagal Efficiency (VE) is calculated as the regression slope of heart period (HP, measured in milliseconds) on respiratory sinus arrhythmia (RSA, expressed as ln(ms²)) across short-time (15-second) epochs collected during seated, standing, and recovery periods of the sit-stand-sit task. VE is reported in units of ms / ln(ms²). The measure is computed only when each condition contains usable data and at least 6 valid epochs (≥50% of the condition).
Measured: Baseline, 8 weeks
Change in Vagal Efficiency Baseline to Follow-up Measured Using HF-HRV and Heart Period Coupling
Vagal Efficiency (VE) is calculated as the regression slope of heart period (HP, measured in milliseconds) on respiratory sinus arrhythmia (RSA, expressed as ln(ms²)) across short-time (15-second) epochs collected during seated, standing, and recovery periods of the sit-stand-sit task. VE is reported in units of ms / ln(ms²). The measure is computed only when each condition contains usable data and at least 6 valid epochs (≥50% of the condition).
Measured: Baseline, 12 weeks
Change in the COVID-19 Stress Scale Baseline to Post-Intervention
The COVID-19 Stress Scale (shortened) is an 18-item self-report questionnaire designed to measure COVID-related anxiety over the past 7 days. Three highly correlated subscales are measured: Danger, Contamination, and Traumatic stress. The Danger and Contamination subscales ask about worries related to the virus with response categories ranging from 0 ("Not at all") to 4 ("Extremely). The Traumatic stress subscale asks about frequency of symptoms and varies from 0 ("Never") to 4 ("Almost Always"). Responses are summed across the subscales for a range of 0-72 with higher values indicating greater COVID-related stress. Two of the subscales, Compulsive Checking and Xenophobia related to COVID, are no longer relevant and are not included.
Measured: Baseline, 8 weeks
Change in the COVID-19 Stress Scale Baseline to Follow-up
The COVID-19 Stress Scale (shortened) is an 18-item self-report questionnaire designed to measure COVID-related anxiety over the past 7 days. Three highly correlated subscales are measured: Danger, Contamination, and Traumatic stress. The Danger and Contamination subscales ask about worries related to the virus with response categories ranging from 0 ("Not at all") to 4 ("Extremely). The Traumatic stress subscale asks about frequency of symptoms and varies from 0 ("Never") to 4 ("Almost Always"). Responses are summed across the subscales for a range of 0-72 with higher values indicating greater COVID-related stress. Two of the subscales, Compulsive Checking and Xenophobia related to COVID, are no longer relevant and are not included.
Measured: Baseline, 12 weeks
Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Post-intervention.
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self report questionnaire that measures mindfulness in a single construct. Respondents are asked to rate how much each of the statements applies to them on a 1-4 scale with 1=Rarely/Not at all and 4 = Almost always resulting in total scores of 12-48. Higher scores reflect greater mindfulness. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 8 weeks.
Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Follow-up
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self report questionnaire that measures mindfulness in a single construct. Respondents are asked to rate how much each of the statements applies to them on a 1-4 scale with 1=Rarely/Not at all and 4 = Almost always resulting in total scores of 12-48. Higher scores reflect greater mindfulness. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline,12 weeks.
Change in the Perceived Stress Scale Baseline to Post-intervention.
The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire that measures the frequency of stress-related feelings in the past month. Responses vary from 0 ("Not at all" to 4 "Very often). Responses are summed resulting in a range of 0-40. Higher scores indicate higher perceived stress. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 8 weeks
Change in the Perceived Stress Scale Baseline to Follow-up.
The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire that measures the frequency of stress-related feelings in the past month. Responses vary from 0 ("Not at all" to 4 "Very often). Responses are summed resulting in a range of 0-40. Higher scores indicate higher perceived stress. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline,12 weeks
Change in the Post-traumatic Growth Inventory Baseline to Post-Intervention
The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of growth and self-improvement after a crisis. The measure consists of statements, such as "I changed my priorities about what is important in life." Responses vary from 0 ("I did not experience this change as a result of my crisis") to 5 ("I experienced this change to a very great degree as a result of my crisis," resulting in total scores of 0-105. Higher scores indicate more growth. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 8 weeks
Change in the Post-traumatic Growth Inventory Baseline to Follow-up
The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of growth and self-improvement after a crisis. The measure consists of statements, such as "I changed my priorities about what is important in life." Responses vary from 0 ("I did not experience this change as a result of my crisis") to 5 ("I experienced this change to a very great degree as a result of my crisis," resulting in total scores of 0-105. Higher scores indicate more growth. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 12 weeks
Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Post-intervention.
The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire that measures key symptoms of PTSD in response to a traumatic event. Respondents indicate the degree to which they are bothered by each symptom with categories ranging from 0 ("Not at All") to 4 ("Extremely") resulting in total scores of 0-80. Higher scores indicate presence of more symptomatology. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 8 weeks
Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Follow-up.
The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire that measures key symptoms of PTSD in response to a traumatic event. Respondents indicate the degree to which they are bothered by each symptom with categories ranging from 0 ("Not at All") to 4 ("Extremely") resulting in total scores of 0-80. Higher scores indicate presence of more symptomatology. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 12 weeks
Change in the Center for Epidemiologic Studies Depression Scale From Baseline to Post-Intervention.
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report questionnaire for assessing symptoms associated with depression. Response options range from 0 ("Rarely or None of the Time") to 3 ("Most or Almost All the Time"). Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 8 weeks.
Change in the Center for Epidemiologic Studies Depression Scale From Baseline to Follow-up.
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report questionnaire for assessing symptoms associated with depression. Response options range from 0 ("Rarely or None of the Time") to 3 ("Most or Almost All the Time"). Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 12 weeks.
Change in the Connor-Davidson Resilience Scale From Baseline to Post-Intervention
The Connor-Davidson Resilience Scale (CD RISC) is a 25-item self-report measure of resilience when faced with difficulties. Respondents are presented with a series of statements and asked how much the statements apply to them. Responses range from 0 ("Not at all true") to 4 ("True nearly all the time"). Responses are summed to range from 0 to 100. Higher scores indicate more resilience. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 8 weeks
Change in the Connor-Davidson Resilience Scale From Baseline to Post-Intervention
The Connor-Davidson Resilience Scale (CD RISC) is a 25-item self-report measure of resilience when faced with difficulties. Respondents are presented with a series of statements and asked how much the statements apply to them. Responses range from 0 ("Not at all true") to 4 ("True nearly all the time"). Responses are summed to range from 0 to 100. Higher scores indicate more resilience. The among-group differences in the change scores are compared by ANOVA.
Measured: Baseline, 12 weeks
Change in the Mental Health Quality of Life Baseline to Post-Intervention
Mental Health Quality of Life Total Score: Mental Health Quality of Life (MHQoL) is an 8-item self-report questionnaire. The Mental Health Quality of Life Total Score is calculated as a sum of the first 7 items (self-image, independence, mood, relationships, daily activities, physical health, and future), with response levels ranging from 0 ("Very dissatisfied") to 3 ("Very satisfied"). The total score has a range of 0-21. Higher scores indicate better quality of life.
The among-group difference in the change scores for both are compared by ANOVA.
Measured: Baseline, 8 weeks
Change in the Mental Health Quality of Life Baseline to Follow-up
Mental Health Quality of Life Total Score: Mental Health Quality of Life (MHQoL) is an 8-item self-report questionnaire. The Mental Health Quality of Life Total Score is calculated as a sum of the first 7 items (self-image, independence, mood, relationships, daily activities, physical health, and future), with response levels ranging from 0 ("Very dissatisfied") to 3 ("Very satisfied"). The total score has a range of 0-21. Higher scores indicate better quality of life.
The among-group difference in the change scores for both are compared by ANOVA.
Measured: Baseline, 12 weeks
Change in the Problem-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention
The Problem-focused coping subscale of the Coping Orientation to Problems Experienced Inventory is an 8-item, self-report subscale. Problem-focused coping refers to using informational support, planning, and positive reframing. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater problem-focused coping.
Measured: Baseline, 8 weeks
Change in the Emotion-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention
The Emotion-focused coping subscale of the Coping Orientation to Problems Experienced Inventory in a 12-item, self-report subscale. Emotion-focused coping refers to using venting, emotional support, humor, acceptance, self-blame, and religion. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater emotion-focused coping.
Measured: Baseline, 8 weeks
Change in the Avoidant Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention
The avoidant-focused coping subscale of the Coping Orientation to Problems Experienced Inventory is an 8-item, self-report subscale. Avoidant coping refers to using self-distraction, denial, substance use, and behavioral disengagement. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater avoidant coping.
Measured: Baseline, 8 weeks
Change in the Problem-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up
The Problem-focused coping subscale of the Coping Orientation to Problems Experienced Inventory is an 8-item, self-report subscale. Problem-focused coping refers to using informational support, planning, and positive reframing. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater problem-focused coping.
Measured: Baseline, 12 weeks
Change in the Emotion-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up
The Emotion-focused coping subscale of the Coping Orientation to Problems Experienced Inventory in a 12-item, self-report subscale. Emotion-focused coping refers to using venting, emotional support, humor, acceptance, self-blame, and religion. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater emotion-focused coping.
Measured: Baseline, 12 weeks
Change in the Avoidant Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up
The avoidant-focused coping subscale of the Coping Orientation to Problems Experienced Inventory is an 8-item, self-report subscale. Avoidant coping refers to using self-distraction, denial, substance use, and behavioral disengagement. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater avoidant coping.
Measured: Baseline, 12 weeks
Change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance 8b Short Form T-score, Baseline to Post-intervention.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8b Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration over the past 7 days. This instrument includes 8 items rated on a 5-point Likert scale (1 = not at all to 5 = very much). Raw scores are summed and converted to standardized T-scores based on the PROMIS adult reference population. T-scores have a mean of 50 and a standard deviation of 10, where 50 represents the average level of sleep disturbance in the general U.S. population.
Higher T-scores indicate greater sleep disturbance (worse outcome), while lower T-scores indicate less sleep disturbance (better outcome). Clinically, T-scores of approximately 60 or higher are considered indicative of elevated sleep disturbance, and scores of 70 or higher may reflect severe sleep disturbance.
Measured: Baseline, 8 weeks
Change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance 8b Short Form T-score, Baseline to Follow-up.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8b Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration over the past 7 days. This instrument includes 8 items rated on a 5-point Likert scale (1 = not at all to 5 = very much). Raw scores are summed and converted to standardized T-scores based on the PROMIS adult reference population. T-scores have a mean of 50 and a standard deviation of 10, where 50 represents the average level of sleep disturbance in the general U.S. population.
Higher T-scores indicate greater sleep disturbance (worse outcome), while lower T-scores indicate less sleep disturbance (better outcome). Clinically, T-scores of approximately 60 or higher are considered indicative of elevated sleep disturbance, and scores of 70 or higher may reflect severe sleep disturbance.
Measured: Baseline, 12 weeks
Change in the Short Form Health Survey (SF-12), Baseline to Post-intervention
The Short Form Health Survey (SF-12) is a 12-item self-report questionnaire that assesses aspects of physical health and mental well-being. Scoring is complex and includes both positive and negatively worded items and is translated into a score of 0-100. Higher scores indicate better physical and mental health functioning.
Measured: Baseline, 8 weeks
Change in the Short Form Health Survey (SF-12), Baseline to Follow-up
The Short Form Health Survey (SF-12) is a 12-item self-report questionnaire that assesses aspects of physical health and mental well-being. Scoring is complex and includes both positive and negatively worded items and is translated into a score of 0-100. Higher scores indicate better physical and mental health functioning.
Measured: Baseline, 12 weeks
Proportion of Participants Who Completed the Study
Retention will be compared between the active intervention arms and is defined as the number of individuals randomized who did not withdraw from the study or were administratively censored.
Measured: 12 weeks
Proportion of Participants Who Complete the Intervention
Completers are defined as randomized participants who either attend a minimum of 5 classes (MTIA arm) or view material for a minimum of 5 weeks in the MAPP. The proportion of completers will be compared between groups.
Measured: 8 weeks
Client Satisfaction Questionnaire-internet at the End of the Intervention
The Client satisfaction questionnaire-internet (CSQ-I) is an 8-item measure developed in Germany to assess satisfaction with telehealth interventions. the CSQ-I consists of seven statements that address satisfaction with an online program and willingness to refer others. The investigators have adjusted the 4 response categories for an American sample to use the standard agreement scale (1=strongly disagree, 2= mildly disagree, 3=mildly agree, 4= strongly agree). Mean scores are calculated which can range from 1-4 with higher scores representing greater satisfaction. The questionnaire will be assessed among participants in the intervention arms at the end of the interventions.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start13 May 2024
- Primary completion27 May 2025
- Study completion27 May 2025
Why it stopped: Primary funding termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel arms (MTIA intervention, MAPP intervention, wait-list control group)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), RTI International
- Responsible party
- Sponsor
- Investigators
- Susan Gaylord, PhD, Principal investigator, University of North Carolina, Chapel HillMaria Davila, PhD, Principal investigator, Research Triangle Institute (RTI)Keri J Heilman, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242080
- Sponsor's protocol ID
- 23-0154
- Other IDs
- 5R01MD017051
- Acronym
- SMILE
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2024
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC/RTI.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Platform (DHP) to Deliver Mindfulness as a Stress Management Intervention Leveraging Electronic (SMILE) Health Records for Racial and Ethnic Populations During the COVID-19 Pandemic: Clinical Trial
- ClinicalTrials.gov ID
- NCT06242080
- Acronym / sponsor ID
- SMILE / 23-0154
- Conditions
- Anxiety, COVID-19 Pandemic
- Keywords
- Digital Health Platform, Heart Rate Variability, Mindfulness, Cultural/ethnic health disparities
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary funding termination
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), RTI International
- Study start
- 13 May 2024 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Baseline assessment (week 0). Participants will complete demographic and psychological questionnaires followed by a Heart Rate Variability (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)).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 3 parallel arms (MTIA intervention, MAPP intervention, wait-list control group)
| Arm | Type | Receives |
|---|---|---|
| "MTIA" intervention | Active comparator | Behavioral: MindfulnessThe 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. |
| "MAPP" intervention | Active comparator | Behavioral: MindfulnessThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessMindfulness 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. | Behavioural | "MAPP" intervention, "MTIA" intervention |
Primary outcome
Change From Baseline to Post-Intervention in the Generalized Anxiety Disorder-7 Scale
Time frame: Baseline, 8 week
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. The among-group differences in the change scores are compared by ANOVA.
Change From Baseline to Follow-up in the Generalized Anxiety Disorder-7 Scale
Time frame: Baseline, 12 weeks
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. The among-group differences in the change scores are compared by ANOVA.
35 secondary outcomes
Change in Autonomic Activity From Baseline to Post-Intervention as Measured by Heart Period
Time frame: Baseline, 8 weeks
Change in Autonomic Activity From Baseline to Follow-up as Measured by Heart Period
Time frame: Baseline, 12 weeks
Change in Parasympathetic Activity Baseline to Post-Intervention as Measured by High-frequency Heart Rate Variability (HF-HRV)
Time frame: Baseline, 8 weeks
Change in Parasympathetic Activity Baseline to Follow-up as Measured by High-frequency Heart Rate Variability (HF-HRV)
Time frame: Baseline, 12 weeks
Change in Vagal Efficiency Baseline to Post-intervention Measured Using HF-HRV and Heart Period Coupling
Time frame: Baseline, 8 weeks
Change in Vagal Efficiency Baseline to Follow-up Measured Using HF-HRV and Heart Period Coupling
Time frame: Baseline, 12 weeks
Change in the COVID-19 Stress Scale Baseline to Post-Intervention
Time frame: Baseline, 8 weeks
Change in the COVID-19 Stress Scale Baseline to Follow-up
Time frame: Baseline, 12 weeks
Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Post-intervention.
Time frame: Baseline, 8 weeks.
Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Follow-up
Time frame: Baseline,12 weeks.
Change in the Perceived Stress Scale Baseline to Post-intervention.
Time frame: Baseline, 8 weeks
Change in the Perceived Stress Scale Baseline to Follow-up.
Time frame: Baseline,12 weeks
Change in the Post-traumatic Growth Inventory Baseline to Post-Intervention
Time frame: Baseline, 8 weeks
Change in the Post-traumatic Growth Inventory Baseline to Follow-up
Time frame: Baseline, 12 weeks
Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Post-intervention.
Time frame: Baseline, 8 weeks
Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Follow-up.
Time frame: Baseline, 12 weeks
Change in the Center for Epidemiologic Studies Depression Scale From Baseline to Post-Intervention.
Time frame: Baseline, 8 weeks.
Change in the Center for Epidemiologic Studies Depression Scale From Baseline to Follow-up.
Time frame: Baseline, 12 weeks.
Change in the Connor-Davidson Resilience Scale From Baseline to Post-Intervention
Time frame: Baseline, 8 weeks
Change in the Connor-Davidson Resilience Scale From Baseline to Post-Intervention
Time frame: Baseline, 12 weeks
Change in the Mental Health Quality of Life Baseline to Post-Intervention
Time frame: Baseline, 8 weeks
Change in the Mental Health Quality of Life Baseline to Follow-up
Time frame: Baseline, 12 weeks
Change in the Problem-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention
Time frame: Baseline, 8 weeks
Change in the Emotion-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention
Time frame: Baseline, 8 weeks
Change in the Avoidant Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention
Time frame: Baseline, 8 weeks
Change in the Problem-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up
Time frame: Baseline, 12 weeks
Change in the Emotion-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up
Time frame: Baseline, 12 weeks
Change in the Avoidant Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up
Time frame: Baseline, 12 weeks
Change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance 8b Short Form T-score, Baseline to Post-intervention.
Time frame: Baseline, 8 weeks
Change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance 8b Short Form T-score, Baseline to Follow-up.
Time frame: Baseline, 12 weeks
Change in the Short Form Health Survey (SF-12), Baseline to Post-intervention
Time frame: Baseline, 8 weeks
Change in the Short Form Health Survey (SF-12), Baseline to Follow-up
Time frame: Baseline, 12 weeks
Proportion of Participants Who Completed the Study
Time frame: 12 weeks
Proportion of Participants Who Complete the Intervention
Time frame: 8 weeks
Client Satisfaction Questionnaire-internet at the End of the Intervention
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC/RTI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Gaylord, PhD principal investigator
University of North Carolina, Chapel Hill
Maria Davila, PhD principal investigator
Research Triangle Institute (RTI)
Keri J Heilman, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Anxiety and COVID-19 Pandemic, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Post-Intervention in the Generalized Anxiety Disorder-7 Scale (time frame: Baseline, 8 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.