Clinical trial NCT04734171: Social Activity, Loneliness and Stigma During COVID-19 Outbreak
Official title: COVID-19 and Its Implications on Social Activity, Loneliness and Stigma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Fear
Loneliness
Keywords: Covid19 related stigma, fear and loneliness
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: New York State Psychiatric Institute
First posted: 2021-02-02
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Younger than 70 years old
* United States resident

Exclusion Criteria:

* Less than 18 years old

Primary outcomes:
measure: Change in total stigma score 2 weeks after the intervention
timeFrame: Baseline and 2 weeks
measure: Change in total fear score 2 weeks after the intervention
timeFrame: Baseline and 2 weeks
measure: Change in loneliness ordinal score 2 weeks after the intervention
timeFrame: Baseline and 2 weeks
measure: Change in fear of people COVID-19+ ordinal score 2 weeks after the intervention
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Change in time spent on internet ordinal score 2 weeks after the intervention
timeFrame: Baseline and 2 weeks
measure: Change in social activity ordinal score 2 weeks after the intervention
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Assistant Professor of Biostatistics
name: Linda Valeri, PhD
role: PRINCIPAL_INVESTIGATOR
References: