A Smartphone-Based Intervention for Anxiety and Depression in Racially and Ethnically Diverse Adults (EASE): Protocol for a Randomized Controlled Trial.

BACKGROUND: Clear health disparities have emerged in the rates of COVID-19 exposure, hospitalization, and death among Black, Hispanic, and American Indian (BHAI) individuals, relative to non-Hispanic White (NHW) individuals. BHAI populations have been disproportionately affected by lower behavioral health access and heightened negative mental health outcomes during the pandemic. OBJECTIVE: This project directly addresses health disparities in access to behavioral health care during the COVID-19 pandemic among BHAI populations via an adaptation of the established, initially validated, low-cost, mobile app Easing Anxiety Sensitivity for Everyone (EASE) among individuals with symptoms of elevated anxiety or depression or both. METHODS: The EASE trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. Participants (N=800; n=200, 25%, Black; n=200, 25%, Hispanic; n=200, 25%, American Indian; and n=200, 25%, NHW) are randomized to receive either EASE or an active comparison condition for anxiety and depression. Participants compete an online prescreener, an enrollment call to provide informed consent, a baseline survey, a 6-month intervention period, and 3- and 6-month postbaseline assessments. Select participants also complete a 3- and 6-month postbaseline qualitative interview via phone or an online platform (eg, Zoom). Participants complete 2 scheduled daily ecological momentary assessments (EMAs) during the 6-month study period. These twice-daily EMAs guide a just-in-time approach to immediate, personalized behavioral health care. RESULTS: Outcomes include reductions in anxiety and depressive symptoms and functional impairment at 3 and 6 months postrandomization. We also will examine putative mechanisms (eg, anxiety sensitivity [AS] and COVID-19-specific stress and fear) of the intervention effects. Further, as treatment effects may differ across sociocultural factors, perceived discrimination, social support, and socioeconomic status (SES) will be evaluated as potential moderators of treatment effects on the primary outcomes. Process evaluation using data collected during the study, as well as individual interviews with participants, will complement quantitative data. CONCLUSIONS: Data from this efficacy trial will determine whether EASE successfully improves symptoms of anxiety and depression and whether these improvements outperform an active comparison control app. If successful, findings from this study have the potential to decrease anxiety and depression symptoms among vulnerable populations determined to be most at risk of exacerbated, long-lasting negative health sequelae. Data from this study may be used to support an implementation and dissemination trial of EASE within real-world behavioral health and social service settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05074693; https://clinicaltrials.gov/ct2/show/NCT05074693. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40713.

Pandemic-Related Stress May Be Associated with Symptoms of Poor Mental Health Among African Americans.

The COVID-19 pandemic has disproportionately affected African Americans and has been a significant source of stress for this population due to increased economic hardship and social isolation. This study characterized the associations between COVID-19 vulnerability (e.g., contracting the illness or losing a loved one), pandemic-related stress, and symptoms of poor mental health among African Americans. The study sample included African Americans (N = 304) who responded to an online survey. Symptoms of poor mental health were assessed using the PHQ-4, which assessed symptoms of depression and anxiety. Vulnerability to COVID-19 was measured via self-report in three ways: (1) personal vulnerability, (2) family vulnerability, and (3) community vulnerability (i.e., friends, neighbors, and co-workers). Pandemic-related stress was measured by asking participants to rate how difficult it has been to access essential resources and services, manage finances, and plan or attend social events since March 13, 2020. Data were analyzed using multivariable logistic regression. Results showed that COVID-19 vulnerability was not associated with symptoms of depression or anxiety, but pandemic-related stress was consistently associated with symptoms of poor mental health. Study findings highlight the need to monitor and intervene on pandemic-related stress to prevent further psychological distress within this vulnerable and underserved population.