Clinical trial NCT05074693: Mobile Health and COVID-19
Official title: Mobile Health to Monitor Risk for COVID-19 and Improve Mental Health During the Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
Keywords: COVID-19
Health Disparities
Mobile Health
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
name: Oklahoma State University
First posted: 2021-10-12
Enrollment: 824
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: From Baseline to end of study, up to 6-months
measure: Change from Screener in anxiety on the 5-item Overall Anxiety Severity and Impairment Scale at follow-up appointments.
timeFrame: From Baseline to end of study, up to 6 months
measure: Change from Screener in depression on the 5-item Overall Depression Severity and Impairment Scale at subsequent follow-up appointments.
timeFrame: From Baseline to end of study, up to 6 months
Secondary outcomes:
measure: Perceived discrimination
timeFrame: From Baseline to end of study, up to 6 months.
measure: Racial bias/discrimination
timeFrame: From Baseline to end of study, up to 6 months.
measure: Perceive Social Support
timeFrame: From Baseline to end of study, up to 6 months.
measure: Subjective Social Status
timeFrame: From Baseline to end of study, up to 6 months.
measure: Anxiety Sensitivity
timeFrame: Baseline to end of study, up to 6 months.
measure: Discrimination Burden
timeFrame: From Baseline to end of study, up to 6 months.
measure: Fear of COVID-19
timeFrame: Baseline to end of study, up to 6 months.
measure: Acculturation
timeFrame: Baseline
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: TSET Health Promotion Research Center
state: Oklahoma
city: Houston
country: United States
facility: RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
state: Texas
Study officials:
References: