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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 369
- Locations
- 1
- Primary Endpoint
- Change from Baseline to Post-Intervention in the Generalized Anxiety Disorder-7 scale
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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. 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.
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. 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.
Secondary Outcomes
- 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 Follow-up as measured by high-frequency heart rate variability (HF-HRV)(Baseline, 12 weeks)
- Change in Vagal efficiency Baseline to Follow-up measured using HF-HRV and heart period coupling(Baseline, 12 weeks)
- Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Post-intervention.(Baseline, 8 weeks.)
- Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Post-intervention.(Baseline, 8 weeks)
- Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Follow-up.(Baseline, 12 weeks)
- Change in the Center for Epidemiologic Studies Depression Scale from Baseline to Post-Intervention.(Baseline, 8 weeks.)
- Change in Parasympathetic activity Baseline to Post-Intervention as measured by high-frequency heart rate variability (HF-HRV)(Baseline, 8 weeks)
- Change in Vagal efficiency Baseline to Post-intervention measured using HF-HRV and heart period coupling(Baseline, 8 weeks)
- Change in the COVID-19 Stress Scale Baseline to Post-Intervention(Baseline, 8 weeks)
- Change in the COVID-19 Stress Scale Baseline to Follow-up(Baseline, 12 weeks)
- Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Follow-up(Baseline,12 weeks.)
- Change in the Connor-Davidson Resilience Scale from Baseline to Post-Intervention(Baseline, 12 weeks)
- Change in the Problem-focused coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Post-intervention(Baseline, 8 weeks)
- Proportion of participants who completed the study(12 weeks)
- Proportion of participants who complete the intervention(8 weeks)
- Client satisfaction questionnaire-internet at the end of the intervention(8 weeks)
- Change in the Perceived Stress Scale Baseline to Post-intervention.(Baseline, 8 weeks)
- Change in the Post-traumatic Growth Inventory Baseline to Post-Intervention Change in the Posttraumatic Growth Inventory from Baseline to Post-Intervention(Baseline, 8 weeks)
- Change in the Mental Health Quality of Life Baseline to Follow-up(Baseline, 12 weeks)
- Change in the Perceived Stress Scale Baseline to Follow-up.(Baseline,12 weeks)
- Change in the Post-traumatic Growth Inventory Baseline to Follow-up(Baseline, 12 weeks)
- Change in the Center for Epidemiologic Studies Depression Scale from Baseline to Follow-up.(Baseline, 12 weeks.)
- Change in the Mental Health Quality of Life Baseline to Post-Intervention(Baseline, 8 weeks)
- Change in the Short Form Health Survey (SF-12), Baseline to Follow-up(Baseline, 12 weeks)
- Change in the Emotion-focused coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Post-intervention(Baseline, 8 weeks)
- Change in the Avoidant coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Post-intervention(Baseline, 8 weeks)
- Change in the Avoidant coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Follow-up(Baseline, 12 weeks)
- Change in the Patient-Reported Outcomes Measurement Information System sleep disturbance 8b short form T-score, Baseline to Follow-up.(Baseline, 12 weeks)
- Change in the Problem-focused coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Follow-up(Baseline, 12 weeks)
- Change in the Emotion-focused coping subscale of the Coping Orientation to Problems Experienced Inventory from Baseline to Follow-up(Baseline, 12 weeks)
- Change in the Patient-Reported Outcomes Measurement Information System sleep disturbance 8b short form T-score, Baseline to Post-intervention.(Baseline, 8 weeks)
- Change in the Short Form Health Survey (SF-12), Baseline to post-intervention(Baseline, 8 weeks)