Social Activity, Loneliness and Stigma During COVID-19 Outbreak

Covid19 Clinical Trial

Official title:

COVID-19 and Its Implications on Social Activity, Loneliness and Stigma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734171
• Other study ID #: AAAT0067
• Status: Completed
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: April 16, 2020

Study information

• Verified date: February 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• At least 18 years old

• Younger than 70 years old

• United States resident

Exclusion Criteria:

• Less than 18 years old

Related Conditions & MeSH terms

• Covid19
• Fear
• Loneliness

Intervention

Behavioral:
• Digital social activity video intervention
A 150 seconds video aimed at encouraging the use of a digital device (i.e. not in person contact) to meet with friends during the COVID-19 pandemic. Two friends meet via zoom instead of in person and share their experiencing supporting each other.
• Informational sheet
An informational sheet to learn about the COVID-19 outbreak (standard).
• Stigma awareness video intervention
A video aimed at sensitizing participants to COVID-19 related stigma. A COVID-19 + individual share their experience.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total stigma score 2 weeks after the intervention	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).; Strongly disagree = 1; Disagree = 2; Agree = 3; Strongly agree = 4; prefer not to answer: missing value	Baseline and 2 weeks
Primary	Change in total fear score 2 weeks after the intervention	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.; Not at all = 1; A bit = 2; Quite a bit = 3; A lot = 4; OR; Strongly disagree = 1; Disagree = 2; Agree = 3; Strongly agree = 4; Prefer not to answer = missing value	Baseline and 2 weeks
Primary	Change in loneliness ordinal score 2 weeks after the intervention	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?; Not at all = 1; A bit = 2; Quite a bit = 3; A lot = 4	Baseline and 2 weeks
Primary	Change in fear of people COVID-19+ ordinal score 2 weeks after the intervention	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)?; Not at all = 1; A bit = 2; Quite a bit = 3; A lot = 4	Baseline and 2 weeks
Secondary	Change in time spent on internet ordinal score 2 weeks after the intervention	Ordinal variable from the questionnaire item time spent on the internet (for leisure or work-related activities) in the past week (averaged in number of hours)(1 = less time, 4 = more time): <1 h = 1; 1h-4h = 2; 4h-7h = 3; >7h = 4	Baseline and 2 weeks
Secondary	Change in social activity ordinal score 2 weeks after the intervention	Ordinal variable from the questionnaire item on social contact seeking behavior in the past week (How many times did you contact [in person or via video call] your friends/family members over the last week (1 = low social activity, 4 = high social activity)?; 0-2 = 1; 2-5 = 2; 5-7 = 3; more than 7 = 4	Baseline and 2 weeks