Anxiety DepressionNCT05074693
Mobile Health and COVID-19
A study testing EASE app in people with Anxiety Depression, run by University of Houston at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- EASE app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 822 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2021to 26 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- Not fluent in English
- Lifetime or significant cognitive impairment
- Identifying as a race/ethnicity for which the corresponding study cell has been filled
Trial locations and contacts
2 sites in 1 country.
United States2 sites
RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment
Houston, Texas, 77204
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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
- Being tested
- EASE app, INSIGHT (Control) App
- Keywords
- COVID-19, Health Disparities, Mobile Health
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EASE appOther
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.
INSIGHT (Control) AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EASE app |
| INSIGHT (Control) APP | Other | The Insight app provides users with educational videos on mindfulness and meditation techniques. Receives: Other: INSIGHT (Control) App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From Screener to 6-Month
Secondary outcomes (8)
Perceived Discrimination
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.
Measured: 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. The CRBS is a mean score, with higher scores indicating greater coronavirus racial bias.
Measured: 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. 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.
Measured: 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. The MSSS is not score but has a range from 0 to 10.
Measured: 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. The SSASI is a total score with a range from 0 to 20, with higher scores indicating greater anxiety sensitivity.
Measured: 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. 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.
Measured: 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. The FCV is summed for a total score with a range from 5 to 25. Higher scores indicate greater fear of COVID-19.
Measured: Baseline to end of study, up to 6 months.
Acculturation
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start20 Dec 2021
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma, Oklahoma State University
- Responsible party
- Principal investigator, Michael J. Zvolensky, Ph.D., University of Houston
- Investigators
- Michael Zvolensky, Ph.D., Principal investigator, University of HoustonMichael Businelle, Ph.D., Principal investigator, University of Oklahoma Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074693
- Sponsor's protocol ID
- STUDY00002802
- Status last verified
- May 2026
- First submitted
- 2 Oct 2021
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40709831Garey 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.
PubMed 36409958
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health to Monitor Risk for COVID-19 and Improve Mental Health During the Pandemic
- ClinicalTrials.gov ID
- NCT05074693
- Acronym / sponsor ID
- STUDY00002802
- Conditions
- Anxiety Depression
- Keywords
- COVID-19, Health Disparities, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- University of Oklahoma, Oklahoma State University
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EASE App | Experimental | Other: EASE appEASE 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. |
| INSIGHT (Control) APP | Other | Other: INSIGHT (Control) AppThe Insight app provides users with educational videos on mindfulness and meditation techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- Not fluent in English
- Lifetime or significant cognitive impairment
- Identifying as a race/ethnicity for which the corresponding study cell has been filled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EASE appEASE 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 | EASE App |
| INSIGHT (Control) AppA 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. | Other | INSIGHT (Control) APP |
Primary outcome
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.
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.
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.
8 secondary outcomes
Perceived Discrimination
Time frame: 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.
Perceive Social Support
Time frame: 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.
Anxiety Sensitivity
Time frame: Baseline to end of study, up to 6 months.
Discrimination Burden
Time frame: 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.
Acculturation
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40709831Rhudy 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.
- Derived from this study: PubMed 36409958Garey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zvolensky, Ph.D. principal investigator
University of Houston
Michael Businelle, Ph.D. principal investigator
University of Oklahoma Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EASE app in people with Anxiety Depression, run by University of Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Everyday Impairment (time frame: From Baseline to 6-Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.