COVID-19 and Its Implications on Social Activity, Loneliness and Stigma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Change in total fear score 2 weeks after the intervention
研究概览
简要总结
The overall goal of this study is to evaluate the association of quarantine measures for COVID-19 and perceived anxiety, stigma and loneliness and to evaluate the efficacy of interventions in reducing anxiety, loneliness and perception of stigma induced by self-isolation during the outbreak.
Specific Aims:
In the proposed study, participants will include members of the United States general population who will be randomly assigned to either (a) a vignette to learn about the COVID-19 outbreak, (b) a vignette to learn about the COVID-19 outbreak AND a video aimed at encouraging the use of a digital device (i.e. not in person contact) to meet with friends, (c) a vignette to learn about the COVID-19 outbreak AND a video aimed at sensitizing participants to COVID-19 related stigma, (d) Control arm. Web-based self-report questionnaires will be conducted to compare interventions and control groups. The short and low-cost online module will allow recruitment of a large sample of people.
Hypotheses:
(1) the video-based intervention groups will demonstrate lower rates of anxiety and loneliness than vignette and control groups, (2) the video-based group that presents an individual with COVID-19 will demonstrate lower rate of stigma than other groups.
详细描述
Currently, the world is experiencing a Coronavirus outbreak, COVID-19, which originated in mainland China in December 2019, spread rapidly to South Korea and Europe, Italy in particular, between January and March of 2020 and is currently spreading in all continents and has been recognized as a pandemic. It is of high importance to monitor how the trends in COVID-19 outbreak are shaping the social contexts and norms across communities and families. In a time in which individuals all over the world are experiencing quarantine, it is important to evaluate the potential surge of the phenomena of social anxiety, stigma, and of perceived fear and loneliness. Furthermore, it is critical to study interventions that aim to reduce each of these. The overall goal of this study is to evaluate the association of quarantine measures for COVID-19 and perceived anxiety, stigma and loneliness and to evaluate the efficacy of interventions in reducing anxiety, loneliness and perception of stigma induced by self-isolation during the outbreak. The hypotheses will be tested using ANOVA and multinomial logistic regressions. An alpha level of 0.01 will be used to account for multiple testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Younger than 70 years old
- •United States resident
排除标准
- •Less than 18 years old
结局指标
主要结局
Change in total fear score 2 weeks after the intervention
时间窗: Baseline and 2 weeks
This is designed to measure fear associated with COVID-19. A continuous variable will be obtained as a sum of questionnaire items (4 questions, score range 4-16, 4 = low fear, 16 = high fear) addressing fear of contracting COVID-19 and fear of consequences of COVID-19. 1. Not at all = 1 2. A bit = 2 3. Quite a bit = 3 4. A lot = 4 OR 1. Strongly disagree = 1 2. Disagree = 2 3. Agree = 3 4. Strongly agree = 4 5. Prefer not to answer = missing value
Change in fear of people COVID-19+ ordinal score 2 weeks after the intervention
时间窗: Baseline and 2 weeks
Ordinal variable from the questionnaire item (1 = low fear of people, 4 = high fear of people): How much are you afraid of people diagnosed with Coronavirus (COVID-19)? 1. Not at all = 1 2. A bit = 2 3. Quite a bit = 3 4. A lot = 4
Change in loneliness ordinal score 2 weeks after the intervention
时间窗: Baseline and 2 weeks
Subjects will answer the following questionnaire item and an ordinal variable will be calculated (1 = low loneliness, 4 = high loneliness): How lonely do you feel? 1. Not at all = 1 2. A bit = 2 3. Quite a bit = 3 4. A lot = 4
Change in total stigma score 2 weeks after the intervention
时间窗: Baseline and 2 weeks
This is designed to measure stigma associated with COVID-19. A continuous variable will be obtained as a sum of questionnaire items ordinal answers (4 questions, score range 4-16, 4 = low stigma, 16 = high stigma) adapted from the HIV stigma validated questionnaire (HIV stigma scale, Berger et al., 2001). 1. Strongly disagree = 1 2. Disagree = 2 3. Agree = 3 4. Strongly agree = 4 5. prefer not to answer: missing value
次要结局
- Change in time spent on internet ordinal score 2 weeks after the intervention(Baseline and 2 weeks)
- Change in social activity ordinal score 2 weeks after the intervention(Baseline and 2 weeks)
研究者
Linda Valeri
Assistant Professor of Biostatistics, Department of Biostatistics
Columbia University