Mobile Health and COVID-19

Anxiety Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05074693
• Other study ID #: STUDY00002802
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: August 2023
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 COVID-19 pandemic and to minimize the existing health disparities among Black, Latinx, 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.

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 Latinx, 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 824
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 InsightTM app and over the phone (i.e., qualitative interview)

• Score = 4 on the REALM-SF 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

Related Conditions & MeSH terms

• Anxiety Depression
• COVID-19

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity	Houston	Texas
United States	TSET Health Promotion Research Center	Oklahoma City	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
University of Houston	Oklahoma State University, University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Test of statistical difference between EASE and INSIGHT across this outcome is a primary analysis for this study.	From Baseline to end of study, up to 6-months
Primary	Change from Screener in anxiety on the 5-item Overall Anxiety Severity and Impairment Scale at follow-up appointments.	Test of statistical difference between EASE and INSIGHT across this outcome is a primary analysis for this study.	From Baseline to end of study, up to 6 months
Primary	Change from Screener in depression on the 5-item Overall Depression Severity and Impairment Scale at subsequent follow-up appointments.	Test of statistical difference between EASE and INSIGHT across this outcome is a primary analysis for this study.	From Baseline to end of study, up to 6 months
Secondary	Perceived discrimination	The Everyday Discrimination Scale (EDS) is a six-item scale that assesses perceptions of discrimination or unfair treatment. The Everyday Discrimination Scale will be utilized to explore whether perceived racial discrimination functions as a moderator of treatment effects on the primary outcomes listed as primary outcomes.	From Baseline to end of study, up to 6 months.
Secondary	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.	From Baseline to end of study, up to 6 months.
Secondary	Perceive Social Support	The Perceived Social Support Questionnaire (F-SozU K-6) is a measure of the perceived social support. 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.
Secondary	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.	From Baseline to end of study, up to 6 months.
Secondary	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.	Baseline to end of study, up to 6 months.
Secondary	Discrimination Burden	The discrimination burden section of the Jackson Heart Study Discrimination Instrument will be used to measure perceived experience of discrimination. 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.
Secondary	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.	Baseline to end of study, up to 6 months.
Secondary	Acculturation	The Abbreviated Multidimensional Acculturation Scale assesses an individual's level of acculturation to a host culture. 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