Mobile Health and COVID-19

NCT05074693 | Completed Results DMC

• 1 other identifier: STUDY00002802
• Study Type: interventional
• Target: 822
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anxiety Depression

Keywords

COVID-19; Health Disparities; Mobile Health

Outcome Measures

Primary Outcomes (3)

• Everyday Impairment

  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

  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

  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 Outcomes (8)

• Perceived Discrimination

  From Baseline to end of study, up to 6 months.

• Racial Bias/Discrimination

  From Baseline to end of study, up to 6 months.

• Perceive Social Support

  From Baseline to end of study, up to 6 months.

• Subjective Social Status

  From Baseline to end of study, up to 6 months.

• Anxiety Sensitivity

  Baseline to end of study, up to 6 months.

Study Arms (2)

EASE App

EXPERIMENTAL

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

INSIGHT (Control) APP

OTHER

The Insight app provides users with educational videos on mindfulness and meditation techniques.

Other: INSIGHT (Control) App

Interventions

EASE app OTHER

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.

EASE App

INSIGHT (Control) App OTHER

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.

INSIGHT (Control) APP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• Not fluent in English
• Lifetime or significant cognitive impairment
• Identifying as a race/ethnicity for which the corresponding study cell has been filled

Sponsors & Collaborators

• University of Houston: lead
• University of Oklahoma: collaborator
• Oklahoma State University: collaborator

Study Sites (2)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment

Houston, Texas, 77204, United States

Location

Related Publications (2)

• Rhudy JL, Kell PA, Shadlow JO, Lowe TS, Stephens LD, Zvolensky MJ, Garey L, Kendzor DE, Businelle MS. Assessing racial/ethnic differences in sleep-pain relationships using intensive longitudinal modeling among Native Americans. Sleep. 2026 Jan 13;49(1):zsaf216. doi: 10.1093/sleep/zsaf216.

  PMID: 40709831 DERIVED

• Garey L, Zvolensky MJ, Gallagher MW, Vujanovic A, Kendzor DE, Stephens L, Cheney MK, Cole AB, Kezbers K, Matoska CT, Robison J, Montgomery A, Zappi CV, Businelle MS. A Smartphone-Based Intervention for Anxiety and Depression in Racially and Ethnically Diverse Adults (EASE): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Dec 5;11(12):e40713. doi: 10.2196/40713.

  PMID: 36409958 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Michael Zvolensky, Ph.D.
• Organization: University of Houston

mjzvolen@Central.UH.EDU

713-743-8056

Study Officials

• Michael Zvolensky, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

• Michael Businelle, Ph.D.

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hugh Roy and Lillie Cranz Cullen Distinguished University Professor

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 12, 2021
• Study Start: December 20, 2021
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Locations

US (2)