Clinical trial NCT06242080: SMILE: Clinical Trial to Evaluate Mindfulness as Intervention for Racial and Ethnic Populations During COVID-19
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Anxiety
COVID-19 Pandemic
Keywords: Digital Health Platform
Heart Rate Variability
Mindfulness
Cultural/ethnic health disparities
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: RTI International
First posted: 2024-02-05
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallel arms (MTIA intervention, MAPP intervention, wait-list control group)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline to Post-Intervention in the Generalized Anxiety Disorder-7 scale
timeFrame: Baseline, 8 week
measure: Change from Baseline to Follow-up in the Generalized Anxiety Disorder-7 scale
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Autonomic activity from Baseline to Post-Intervention as measured by heart period
timeFrame: Baseline, 8 weeks
measure: Change in Autonomic activity from Baseline to Follow-up as measured by heart period
timeFrame: Baseline, 12 weeks
measure: Change in Parasympathetic activity Baseline to Post-Intervention as measured by high-frequency heart rate variability (HF-HRV)
timeFrame: Baseline, 8 weeks
measure: Change in Parasympathetic activity Baseline to Follow-up as measured by high-frequency heart rate variability (HF-HRV)
timeFrame: Baseline, 12 weeks
measure: Change in Vagal efficiency Baseline to Post-intervention measured using HF-HRV and heart period coupling
timeFrame: Baseline, 8 weeks
measure: Change in Vagal efficiency Baseline to Follow-up measured using HF-HRV and heart period coupling
timeFrame: Baseline, 12 weeks
measure: Change in the COVID-19 Stress Scale Baseline to Post-Intervention
timeFrame: Baseline, 8 weeks
measure: Change in the COVID-19 Stress Scale Baseline to Follow-up
timeFrame: Baseline, 12 weeks
measure: Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Post-intervention.
timeFrame: Baseline, 8 weeks.
measure: Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Follow-up
timeFrame: Baseline,12 weeks.
measure: Change in the Perceived Stress Scale Baseline to Post-intervention.
timeFrame: Baseline, 8 weeks
measure: Change in the Perceived Stress Scale Baseline to Follow-up.
timeFrame: Baseline,12 weeks
measure: Change in the Post-traumatic Growth Inventory Baseline to Post-Intervention Change in the Posttraumatic Growth Inventory from Baseline to Post-Intervention
timeFrame: Baseline, 8 weeks
measure: Change in the Post-traumatic Growth Inventory Baseline to Follow-up
timeFrame: Baseline, 12 weeks
measure: Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Post-intervention.
timeFrame: Baseline, 8 weeks
measure: Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Follow-up.
timeFrame: Baseline, 12 weeks
measure: Change in the Center for Epidemiologic Studies Depression Scale from Baseline to Post-Intervention.
timeFrame: Baseline, 8 weeks.
measure: Change in the Center for Epidemiologic Studies Depression Scale from Baseline to Follow-up.
timeFrame: Baseline, 12 weeks.
measure: Change in the Connor-Davidson Resilience Scale from Baseline to Post-Intervention
timeFrame: Baseline, 8 weeks
measure: Change in the Connor-Davidson Resilience Scale from Baseline to Post-Intervention
timeFrame: Baseline, 12 weeks
measure: Change in the Mental Health Quality of Life Baseline to Post-Intervention
timeFrame: Baseline, 8 weeks
measure: Change in the Mental Health Quality of Life Baseline to Follow-up
timeFrame: Baseline, 12 weeks
measure: Change in the Problem-focused coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Post-intervention
timeFrame: Baseline, 8 weeks
measure: Change in the Emotion-focused coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Post-intervention
timeFrame: Baseline, 8 weeks
measure: Change in the Avoidant coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Post-intervention
timeFrame: Baseline, 8 weeks
measure: Change in the Problem-focused coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Follow-up
timeFrame: Baseline, 12 weeks
measure: Change in the Emotion-focused coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Follow-up
timeFrame: Baseline, 12 weeks
measure: Change in the Avoidant coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Follow-up
timeFrame: Baseline, 12 weeks
measure: Change in the Patient-Reported Outcomes Measurement Information System sleep disturbance 8b short form T-score, Baseline to Post-intervention.
timeFrame: Baseline, 8 weeks
measure: Change in the Patient-Reported Outcomes Measurement Information System sleep disturbance 8b short form T-score, Baseline to Follow-up.
timeFrame: Baseline, 12 weeks
measure: Change in the Short Form Health Survey (SF-12), Baseline to post-intervention
timeFrame: Baseline, 8 weeks
measure: Change in the Short Form Health Survey (SF-12), Baseline to Follow-up
timeFrame: Baseline, 12 weeks
measure: Proportion of participants who completed the study
timeFrame: 12 weeks
measure: Proportion of participants who complete the intervention
timeFrame: 8 weeks
measure: Client satisfaction questionnaire-internet at the end of the intervention
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Susan Gaylord, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Triangle Institute (RTI)
name: Maria Davila, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Keri J Heilman, PhD
role: PRINCIPAL_INVESTIGATOR
References: