Anxiety Depression
Conditions
Keywords
COVID-19, Health Disparities, Mobile Health
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.
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
Interventions
OTHEREASE 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.
OTHERINSIGHT (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.
Sponsors
University of Houston
University of Oklahoma
Oklahoma State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Everyday Impairment | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Discrimination | 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. |
| Racial Bias/Discrimination | 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. |
| Perceive Social Support | 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. |
| Subjective Social Status | 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. |
| Anxiety Sensitivity | 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. |
| Discrimination Burden | 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. |
| Fear of COVID-19 | 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. |
| Acculturation | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Zvolensky, Ph.D.
University of Houston
PRINCIPAL_INVESTIGATORMichael Businelle, Ph.D.
University of Oklahoma Health Sciences
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 413 |
| INSIGHT (Control) APP The Insight app provides users with educational videos on mindfulness and meditation techniques. | 409 |
| Total | 822 |
Baseline characteristics
| Characteristic | INSIGHT (Control) APP | Total | EASE App |
|---|---|---|---|
| Age, Continuous | 38.05 Years STANDARD_DEVIATION 12.5 | 38.34 Years STANDARD_DEVIATION 12.7 | 38.63 Years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 98 Participants | 202 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 311 Participants | 620 Participants | 309 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 105 Participants | 208 Participants | 103 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 206 Participants | 103 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 98 Participants | 202 Participants | 104 Participants |
| Race (NIH/OMB) White | 103 Participants | 206 Participants | 103 Participants |
| Sex: Female, Male Female | 262 Participants | 531 Participants | 269 Participants |
| Sex: Female, Male Male | 147 Participants | 291 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 413 | 0 / 409 |
| other Total, other adverse events | 0 / 413 | 0 / 409 |
| serious Total, serious adverse events | 0 / 413 | 0 / 409 |
Outcome results
Primary
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.
Time frame: From Screener to 6-Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| EASE App | Anxiety | Anxiety at Baseline | 10.63 Total Score |
| EASE App | Anxiety | Anxiety at 6-months | 7.32 Total Score |
| INSIGHT (Control) APP | Anxiety | Anxiety at Baseline | 10.84 Total Score |
| INSIGHT (Control) APP | Anxiety | Anxiety at 6-months | 7.59 Total Score |
Primary
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.
Time frame: From Screener to 6-Month
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| EASE App | Depression | Depression at Baseline | 9.74 Total Score |
| EASE App | Depression | Depression at 6-month | 6.45 Total Score |
| INSIGHT (Control) APP | Depression | Depression at Baseline | 9.82 Total Score |
| INSIGHT (Control) APP | Depression | Depression at 6-month | 6.58 Total Score |
Primary
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.
Time frame: From Baseline to 6-Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EASE App | Everyday Impairment | Everyday Impairment at Baseline | 15.65 Scores on a scale | Standard Deviation 2.84 |
| EASE App | Everyday Impairment | Everyday Impairment at 6-month | 12.74 Scores on a scale | Standard Deviation 4.54 |
| INSIGHT (Control) APP | Everyday Impairment | Everyday Impairment at Baseline | 15.47 Scores on a scale | Standard Deviation 2.91 |
| INSIGHT (Control) APP | Everyday Impairment | Everyday Impairment at 6-month | 13.23 Scores on a scale | Standard Deviation 4.4 |
Secondary
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
Time frame: Baseline
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. The SSASI is a total score with a range from 0 to 20, with higher scores indicating greater anxiety sensitivity.
Time frame: 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. 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.
Time frame: 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. The FCV is summed for a total score with a range from 5 to 25. Higher scores indicate greater fear of COVID-19.
Time frame: 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 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.
Time frame: 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. 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.
Time frame: 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. The CRBS is a mean score, with higher scores indicating greater coronavirus racial bias.
Time frame: 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. The MSSS is not score but has a range from 0 to 10.
Time frame: From Baseline to end of study, up to 6 months.