NCT05074693

Mobile Health and COVID-19

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 822 (actual)
• Sponsor: University of Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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 coronavirus disease of 2019 (COVID-19) pandemic and to minimize the existing health disparities among Black, Hispanic and Latino, 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

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 Hispanic and Latino, 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

Conditions

• Anxiety Depression

Interventions

Type	Name	Description
OTHER	EASE app	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.
OTHER	INSIGHT (Control) App	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.

Timeline

• Start date: 2021-12-20
• Primary completion: 2024-01-26
• Completion: 2024-01-26
• First posted: 2021-10-12
• Last updated: 2025-09-24
• Results posted: 2025-09-24

Locations

2 sites across 1 country: United States