Mobile Health to Monitor Risk for COVID-19 and Improve Mental Health During the Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 822
- 试验地点
- 4
- 主要终点
- Everyday Impairment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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)
排除标准
- •Not fluent in English
- •Lifetime or significant cognitive impairment
- •Identifying as a race/ethnicity for which the corresponding study cell has been filled
研究组 & 干预措施
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.
干预措施: EASE app (Other)
INSIGHT (Control) APP
The Insight app provides users with educational videos on mindfulness and meditation techniques.
干预措施: INSIGHT (Control) App (Other)
结局指标
主要结局
Everyday Impairment
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Perceived Discrimination(From Baseline to end of study, up to 6 months.)
- Anxiety Sensitivity(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.)
- Discrimination Burden(From Baseline to end of study, up to 6 months.)
- Fear of COVID-19(Baseline to end of study, up to 6 months.)
- Acculturation(Baseline)
- Acculturation(Baseline)
- Discrimination Burden(From Baseline to end of study, up to 6 months.)
- Fear of COVID-19(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.)
研究者
Michael J. Zvolensky, Ph.D.
Hugh Roy and Lillie Cranz Cullen Distinguished University Professor
University of Houston
