Mobile Health and COVID-19

Study Overview
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Brief Summary
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The proposed research focuses on evaluating the mobile application, Easing Anxiety Sensitivity for Everyone (EASE), to improve overall public health that concerns risks and mental health status during the COVID-19 pandemic and to minimize the existing health disparities among Black, Latinx, and American Indian (BLAI) individuals during this time. EASE provides COVID-19 symptom monitoring, exposure management skills, and psychoeducation on stress and it's impact on infection and disease susceptibility. This study aims to compare the effect of EASE to an empirical measurement of standard-of-care digital intervention and to identify the effective mechanisms in EASE.

Detailed Description
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The objective of the current trial is to address health disparities in access to behavioral health care during the COVID-19 pandemic among BLAI via an adaptation of our established, initially validated, low-cost, mobile application ('app'). Participants (N = 880; 220 Black, 220 Latinx, 220 American Indian, and 220 NLW) will be randomized to either our established clinical grade app: Easing Anxiety Sensitivity for Everyone (EASE; n=440; n=110 from each of the 4 race/ethnic groups), or an active standard-of-care control digital mindfulness/meditation intervention for anxiety and depression (n=440; n=110 from each of the 4 race/ethnic groups). The present study will include a baseline assessment, a 3-month intervention period, a 3-month continued assessment period (with access to intervention materials), and 3- and 6-month post-baseline assessments with a qualitative interview via phone or online platform (e.g., Zoom) at the 6-month follow-up for some participants. Due to the high vulnerability for COVID-19 related medical complications in minority populations, all participants will receive our previously developed COVID-19 monitoring and symptoms intervention component that already is in use (see below for details) for the 6-month study period. In addition, all participants will complete two daily EMAs throughout the study period. For EASE participants, EMAs will guide the just-in-time approach to immediate, personalized behavioral health care. We have had success with participants completing EMAs in our prior work (e.g., approximately 70% of all prompted daily EMAs completed over a 6-month period). Consistent with several of our studies (e.g., Smart-T3 R01, Phoenix, Persist), all assessments will be completed remotely via REDCap and InsightTM app

Official Title
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Mobile Health to Monitor Risk for COVID-19 and Improve Mental Health During the Pandemic

Conditions
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Anxiety Depression

Intervention / Treatment
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* Other: EASE app
* Other: INSIGHT (Control) App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Self-identify as Black, Latinx, American Indian, or NLW Clinically significant anxiety and/or depressive symptoms as evinced by a score of 8 or higher on the Overall Anxiety Severity and Impairment Scale (OASIS) and/or Overall Depression Severity and Impairment Scale (ODSIS) Reside in Texas or Oklahoma Willing/able to complete EMAs on study provided or personal smartphone for 6-month study period Willing and able to complete the 3- and 6-month follow-up assessments via InsightTM app and over the phone (i.e., qualitative interview) Score ≥ 4 on the REALM-SF indicating > 6th grade English literacy level (needed to complete EMAs) Exclusion Criteria: Not fluent in English Lifetime or significant cognitive impairment Identifying as a race/ethnicity for which the corresponding study cell has been filled

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EASE App<br>EASE is a intervention designed to address anxiety and depression symptoms in its users through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress. | Other: EASE app<br>* EASE is a mobile intervention designed to reduce ongoing mental health concerns among BLAI individuals with elevated anxiety and/or depressive symptoms by targeting anxiety sensitivity. The EASE app employs a variety of features to educate its users on how to deal with increased levels of stress, anxiety, and depression, and train users on how to better cope with the negative feelings of stress. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos designed to teach participants how to better deal with stress. EASE also utilizes Ecological Momentary Assessments (EMAs) to gather information, and provide personalized messages to users in real time. Finally, EASE is outfitted with COVID-19 related elements, including a symptoms tracker (which participants can use to report symptoms of COVID-19 they may be experiencing), and a collection of COVID-19 related food, housing, and job placement resources.<br>|
| Other: INSIGHT (Control) APP<br>The Insight app provides users with educational videos on mindfulness and meditation techniques. | Other: INSIGHT (Control) App<br>* A standard of care control intervention was developed using the INSIGHT platform. This app contains a library of educational videos that cover topics such as meditation and mindfulness, as well as general stress reduction techniques. Additionally, participants have access to a Report Distress feature that enables them to report moments when they are feeling high levels of stress. Finally, participants will be able to report any COVID-19 related symptoms they experience using a COVID-19 symptom tracker feature. Participants assigned to this condition will received 2 daily EMAs, during which they will be prompted to watch one of the aforementioned educational videos.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in reported anxiety and depression related impairment experienced in major life sectors (work performance, household maintenance, social interactions, relationships) as measured by study developed items from Baseline to follow-up assessments. | Test of statistical difference between EASE and INSIGHT across this outcome is a primary analysis for this study. | From Baseline to end of study, up to 6-months | 
| Change from Screener in anxiety on the 5-item Overall Anxiety Severity and Impairment Scale at follow-up appointments. | Test of statistical difference between EASE and INSIGHT across this outcome is a primary analysis for this study. | From Baseline to end of study, up to 6 months | 
| Change from Screener in depression on the 5-item Overall Depression Severity and Impairment Scale at subsequent follow-up appointments. | Test of statistical difference between EASE and INSIGHT across this outcome is a primary analysis for this study. | From Baseline to end of study, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived discrimination | The Everyday Discrimination Scale (EDS) is a six-item scale that assesses perceptions of discrimination or unfair treatment. The Everyday Discrimination Scale will be utilized to explore whether perceived racial discrimination functions as a moderator of treatment effects on the primary outcomes listed as primary outcomes. | From Baseline to end of study, up to 6 months. | 
| Racial bias/discrimination | The Coronavirus Racial Bias Scale (CRBS) is a brief self-report questionnaire that measures levels of perceived racial bias/discrimination due to the COVID-19 pandemic. The CRBS will be utilized to explore whether perceived racial discrimination due to the COVID-19 pandemic functions as a moderator of the EASE effects. The CRBS will be utilized to explore whether perceived racial discrimination due to the COVID-19 pandemic functions as a moderator of treatment effects on the primary outcomes listed as primary outcomes. | From Baseline to end of study, up to 6 months. | 
| Perceive Social Support | The Perceived Social Support Questionnaire (F-SozU K-6) is a measure of the perceived social support. Higher scores indicate greater degrees of social support. The F-SozU K-6 will be utilized to explore whether social support functions as a moderator of the treatment effects on the primary outcomes listed as primary outcomes. | From Baseline to end of study, up to 6 months. | 
| Subjective Social Status | The MacArthur Scale of Subjective Social Status is a measures of perceived social status. The MSSS will be utilized to explore whether perceived social status functions as a moderator of the treatment effects on the primary outcomes listed as primary outcomes. | From Baseline to end of study, up to 6 months. | 
| Anxiety Sensitivity | The Short Scale Anxiety Sensitivity Index (SSASI) will be used to explore whether Intervention effects on study outcomes are mediated by reductions in anxiety sensitivity. | Baseline to end of study, up to 6 months. | 
| Discrimination Burden | The discrimination burden section of the Jackson Heart Study Discrimination Instrument will be used to measure perceived experience of discrimination. Higher scores indicate higher difficulty living a productive and full life because of perceived experience of discrimination. This measure will be used to assess whether discrimination burden functions as a moderator of the EASE effects. | From Baseline to end of study, up to 6 months. | 
| Fear of COVID-19 | The Fear of COIVD-19 scale will be used to explore whether intervention effects on study primary outcomes are mediated by reductions in fear related to the COVID-19 pandemic. | Baseline to end of study, up to 6 months. | 
| Acculturation | The Abbreviated Multidimensional Acculturation Scale assesses an individual's level of acculturation to a host culture. For questions that ask participants how strongly they feel apart of U.S. culture, higher scores indicate higher levels of acculturation. For questions that ask about their future of origin, higher score indicate lower levels of acculturation. This measure will be used to assess whether acculturation functions as a moderator of the EASE effects | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Health Disparities, Mobile Health