Mobile Health and COVID-19

September 4, 2025 updated by: Michael J. Zvolensky, Ph.D., University of Houston

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
822

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • TSET Health Promotion Research Center
    • Texas
      • Houston, Texas, United States, 77204
        • RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 the app and over the phone (i.e., qualitative interview)
  • Score ≥ 4 on the REALM-Short Form 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EASE App
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
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
The Insight app provides users with educational videos on mindfulness and meditation techniques.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Everyday Impairment
Time Frame: From Baseline to 6-Months
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. This measure was created by the study team and was 4 items rated from 1 (Strongly disagree) to 5 (Strongly agree). The scale is summed for a total score with ranges from 4 to 25, with higher scores indicating greater everyday impairment.
From Baseline to 6-Months
Anxiety
Time Frame: From Screener to 6-Months
Change from Screener in anxiety on the 5-item Overall Anxiety Severity and Impairment Scale (OASIS) at follow-up appointments. The OASIS is made up of 5 items rated on a scale from 0 to 4. The OASIS is summed for a total score, with a range from 0 to 25, with higher scores indicating higher anxiety severity and impairment.
From Screener to 6-Months
Depression
Time Frame: From Screener to 6-Month
Change from Screener in depression on the 5-item Overall Depression Severity and Impairment Scale (ODSIS) at subsequent follow-up appointments. The ODSIS is made up of 5 items rated on a scale from 0 to 4. The ODSIS is summed for a total score, with a range from 0 to 25, with higher scores indicating higher depression severity and impairment.
From Screener to 6-Month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Discrimination
Time Frame: From Baseline to end of study, up to 6 months.
The Everyday Discrimination Scale (EDS) is a six-item scale that assesses perceptions of discrimination or unfair treatment. The EDS will be utilized to explore whether perceived racial discrimination functions as a moderator of treatment effects on the primary outcomes listed as primary outcomes. The EDS is summed for a total score, with a range from 0 to 20. Higher scores indicate greater everyday discrimination.
From Baseline to end of study, up to 6 months.
Racial Bias/Discrimination
Time Frame: From Baseline to end of study, up to 6 months.
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. The CRBS is a mean score, with higher scores indicating greater coronavirus racial bias.
From Baseline to end of study, up to 6 months.
Perceive Social Support
Time Frame: From Baseline to end of study, up to 6 months.
The Perceived Social Support Questionnaire (F-SozU K-6) is a measure of the perceived social support. The F-SozU K-6 is summed for a total score, with a range from 6 to 24. 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
Time Frame: From Baseline to end of study, up to 6 months.
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. The MSSS is not score but has a range from 0 to 10.
From Baseline to end of study, up to 6 months.
Anxiety Sensitivity
Time Frame: Baseline to end of study, up to 6 months.
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. The SSASI is a total score with a range from 0 to 20, with higher scores indicating greater anxiety sensitivity.
Baseline to end of study, up to 6 months.
Discrimination Burden
Time Frame: From Baseline to end of study, up to 6 months.
The discrimination burden section of the Jackson Heart Study Discrimination Instrument will be used to measure perceived experience of discrimination. The measure is a total score with ranges from 4 to 12. 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
Time Frame: Baseline to end of study, up to 6 months.
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. The FCV is summed for a total score with a range from 5 to 25. Higher scores indicate greater fear of COVID-19.
Baseline to end of study, up to 6 months.
Acculturation
Time Frame: Baseline
The Abbreviated Multidimensional Acculturation Scale (AMAS) assesses an individual's level of acculturation to a host culture. The AMAS is a mean score. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oklahoma
Oklahoma State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Zvolensky, Ph.D., University of Houston
  • Principal Investigator: Michael Businelle, Ph.D., University of Oklahoma Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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